Step 4: Work out your introduction's risk to human health

To be able to finish your categorisation you need to work out the risks of your introduction to human health and the environment.

In Step 4, you need to work out the human health risk of your introduction - is it medium to high, low or very low? To work this out start at 4.1 and continue as far as you need to through each step.

Once you have your answer for human health, move to step 5 to work out the risk to the environment of your introduction.

At Step 6, you'll combine the human health risk and environment risk for the final category of your introduction.

Step 4.1 Introductions that are always medium to high risk for human health

Start at this step to see if your introduction is of a type that is always medium to high risk for human health.

Step 4.2 Introductions that can be low risk for human health

This step relates to international assessments and how to work out if your introduction can be low risk for human health based on its international assessment.

Step 4.3 Work out your human health exposure band

Part of the process to work out the human health risk of your introduction is to work out its exposure band. There are 4 human health exposure bands - exposure band 1 has the lowest level of human exposure and exposure band 4 the highest level. 

Step 4.4 Work out your human health hazard characteristics

A chemical has a human health hazard characteristic if the chemical can cause damage, harm or adverse effects to humans. Find out what you need to do to establish the human health hazard characteristics of your chemical, including when you can refer to our list of chemicals with high hazards for categorisation.

Step 4.5 Outcome - your human health risk for categorisation

Use the table on this page to confirm the human health risk of your introduction: medium to high, low or very low. After you do this go to step 5 to work out the risk to the environment of your introduction.

Step 4.1 Introductions that are always medium to high risk for human health

Some introductions are always medium to high risk to human health. This means they will be in the assessed introduction category and you need to apply for an assessment certificate.

 

You are here because you have already gone through Steps 0, 1, 2 and 3 of the categorisation process.

Instructions

Start from the top and check whether you are introducing any of the 3 types of chemical introductions we describe on this page.

For each one work out if you are, or are not introducing that type of chemical and follow the instructions to find out your outcome or next steps.

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Chemicals that contain a sequence of 4 to 20 fully fluorinated carbon atoms (including per- and poly-fluorinated alkyl substances, known as PFAS)

These chemicals (some known as PFAS) are commonly used in products to add resistance to heat, other chemicals and abrasion. They can also act as dispersion, wetting or surface treatment agents.

We have extra guidance on categorisation of fluorinated chemicals

No I am not introducing this type of chemical

You must have information about your chemical's identity as proof that you're not introducing this type of chemical. You (or the chemical identity holder) need to provide the information if we ask for it.

Next step: Go to 'Certain polyhalogenated organic chemicals' below.

Yes I am introducing this type of chemical

Outcome and next step: Your introduction has a medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an 'assessed introduction'. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

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Certain polyhalogenated organic chemicals

Polyhalogenated organic chemicals are carbon-based chemicals that contain more than 1 covalently bonded halogen atom, such as bromine, chlorine, fluorine or iodine. They may have long-term effects on human health and the environment. They’re commonly used as flame retardants in plastics, textiles and electronic circuitry.

We have extra guidance on the categorisation of polyhalogenated organic chemicals 

No I am not introducing this type of chemical

You must have information about your chemical's identity as proof that you're not introducing this type of chemical. You (or the chemical identity holder) need to provide the information if we ask for it.

Next step: Go to 'Certain chemicals at the nanoscale' below.

Yes I am introducing this type of chemical

If the chemical identity information that you (or the chemical identity holder) have confirms you are introducing this type of chemical, you must consider which of the following circumstances apply to your introduction.

1. Introduced at volumes less than or equal to 100 kg each year

Next step: Go to 'Certain chemicals at the nanoscale' below.

2. Introduced at volumes higher than 100 kg each year

You need to have test results about the persistence of your chemical and any of its known environmental degradation products. To prove that your chemical and any of its known environmental degradation products are not persistent, we accept study results in option 1 or 2.

Option 1

A study conducted following OECD test guideline 301 (Ready Biodegradability) that results in the pass levels being reached within one of the following time periods:

  • specified time period – such that the chemical is considered to be readily biodegradable or
  • duration of the test – but not within the specified time period for the chemical to be considered readily biodegradable, provided biodegradation has started within the specified time period

Option 2

A study conducted following OECD test guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems) that results in both a degradation half-life of less than 2 months in water and 6 months in sediment.

Next step: If you have study results described in option 1 or 2, go to 'Certain chemicals at the nanoscale' below.

If you do not have any study result described in option 1 or 2, then you cannot prove that your chemical (and any of its known environmental degradation products) are not persistent. Your introduction is medium to high indicative risk to human health and the environment. This means your introduction is in the assessed category and called an 'assessed introduction'. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

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Certain chemicals at the nanoscale

We have extra guidance on categorising chemicals at the nanoscale

Introductions of chemicals that meet all of the following criteria are medium to high indicative risk to both human health and the environment. We refer to these introductions as 'certain chemicals at the nanoscale'.

Criteria

  1. It is introduced as a solid or is in a dispersion.
  2. It consists of particles in an unbound state or as an aggregate or agglomerate. At least 50% (by number size distribution) of the particles have at least 1 external dimension in the particle size range of 1nm to 100nm (ie. the nanoscale).
  3. It is not soluble. This means the solubility of the chemical in water is less than 33.3 g/L measured following OECD test guideline 105 or 120 for water solubility; or the dissolution rate of the chemical is not more than 70%.
  4. The introduction of the nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is not incidental to the introduction of the non-nanoscale portion. This is the case if any of the following apply: 
  • the manufacture of the chemical (in Australia or overseas) at the nanoscale is the result of a deliberate manufacturing decision
  • the manufacture of the chemical (in Australia or overseas) at the nanoscale is necessary for the manufacture of the non-nanoscale portion of the chemical. This means that to make the non-nanoscale chemical, part of the chemical has to be at the nanoscale
  • the chemical at the nanoscale has specific technical characteristics that are the intended result of changes in the manufacturing process. For example, if the process of manufacturing the chemical changes in order to change the particle size of the chemical, or its properties at the nanoscale. This could happen by:
    • mechanical actions like milling, grinding, shearing, sieving or sonication
    • chemicals reactions like electrochemical exfoliation, or catalysts
    • other changes such as changes to pressure or temperature or pH or solvent

No I am not introducing this type of chemical

This means that you have information or studies to prove that your chemical does not meet any of the 4 criteria, or it only meets some of the 4 criteria. Below are examples of how you might prove that each criterion are not met.

Criterion 1: How to prove the chemical is not introduced as a solid or in a dispersion.

You might have an SDS or product information sheet that indicates the appearance (for example, in liquid form).

Criterion 2: How to prove that your chemical does not consist of particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale.

You might have a study report about the particle size distribution of the chemical.

Criterion 3: How to prove the chemical is soluble.

You might have a study report from a water solubility test.

Criterion 4: How to prove that the introduction of the nanoscale portion of your chemical is incidental to the non-nanoscale portion.

You might have information about the manufacturing process which explains that although a portion of your chemical is present at the nanoscale:

  • this was not the result of a deliberate manufacturing decision
  • this was not required to manufacture the non-nanoscale portion of your chemical
  • you did not change your manufacturing process in order to manufacture chemicals at the nanoscale with specific technical characteristics

Next step: If you can prove that at least one of the 4 criterion is not met, then continue to step 4.2.

If you can't prove this, then your introduction is considered medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an ‘assessed introduction’. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

Yes I am introducing this type of chemical

This means that your introduction meets all 4 criteria above and is a 'certain chemical at the nanoscale'.

Outcome and next step: Your introduction has a medium to high indicative risk to both human health and the environment. This means your introduction is in the assessed category and called an ‘assessed introduction’. Before you can introduce the chemical, you must apply for an assessment certificate and select 'Health and environment focus' as the application type or apply for a commercial evaluation authorisation (if you meet the strict criteria).

If you've followed the guidance on this page and can prove that your introduction is not any of these, then continue to step 4.2.

Next – Step 4.2 Introductions that can be low risk for human health

Definitions

Known environmental degradation products are the expected breakdown products of the chemical under environmentally relevant conditions. These breakdown products are ones that have been found in scientific literature or studies.

A persistent chemical remains intact in the environment for long periods of time. A chemical is persistent if its degradation half-life (T1/2) is greater than or equal to:

  • 2 days in air or
  • 2 months in water or 6 months in soil or
  • 6 months in sediment.

Step 4.2 Introductions that can be low risk for human health

If you've established your introduction is NOT medium to high risk for human health (Step 4.1), now see if your introduction CAN be low risk for human health. 

 

This step relates to introductions that are internationally assessed for human health. These must meet all of the following criteria to be considered ‘low indicative risk’ for human health.

Skip this step if you are not using an internationally assessed chemical.

Note: Your introduction might still be low indicative risk for human health but you will need to complete steps 4.3, 4.4 and 4.5 to work this out.

Step 4.2.1

Refer to our Guide to categorising internationally assessed introductions. It has extra information for introducers using international assessments and covers scenarios and outcomes for chemicals that are internationally assessed for:

  • human health only
  • the environment only
  • both human health and the environment

It also lists the trusted overseas bodies we accept assessments from.

The relevant section to refer to in the guide to help you complete step 4.2 is Internationally assessed for human health only.

Step 4.2.2

Once you’ve read the guide to categorising internationally assessed introductions, you'll be able to work out whether your introduction either:

  • meets our criteria for internationally assessed for human health 
  • does not meet our criteria for internationally assessed for human health

Your introduction meets our criteria for internationally assessed for human health

Option 1

  • Keep the outcome you already have — your introduction is low risk for human health; and
  • Go to step 5 to start categorising your introduction's indicative risk for the environment.

Option 2

Check to see if your introduction can be very low risk for human health by completing the rest of step 4:

Once you’ve done this, go to step 4.5 for your final answer.

Your introduction does not meet our criteria for internationally assessed for human health

Continue with step 4 to work out your introduction's risk for human health.

Next:

Once you’ve done this, go to step 4.5 for your final answer.

Step 4.3 Work out your human health exposure band

Are you introducing a chemical with an end use in tattoo inks or personal vaporisers? If you are, your introduction is automatically in exposure band 4 for human health - go to Step 4.4 Work out your human health hazard characteristics.

Look at the questions / scenarios we pose under each exposure band to work out your exposure band.

For some scenarios, you need to know your human health categorisation volume - follow our guidance on how to work this out

  • You need to know certain information about your introduction to be able to work out your human health exposure band. For example, you might need to know the volume you are introducing.
  • There are 4 exposure bands - start at exposure band 1 and work down the page.
  • Each exposure band directs you to your next step depending on your answer.
  • When you know your exposure band, you then need to work out the human health hazard characteristics of your introduction (step 4.4)

Why you need to work out your introduction's exposure band?

It is part of the process to identify the indicative human health risk of your introduction. In step 5, you also have to work out your introduction's environment exposure band.

What does a human health exposure band identify about your introduction?

It identifies the likelihood and extent of human exposure to the chemical.  This likelihood and extent of exposure increases with each band. Exposure band 4 is the highest exposure band. Introductions in human health exposure band 4 will have the highest level of human exposure.

Information that's used to assign a chemical to its correct exposure band

Need to know your human health categorisation volume?

Follow our guidance on how to work this out

You can also get help to work this out using our online decision tool

The information you need to be able to work out your exposure band can be different depending on the exposure band criteria you will be using. Some of the exposure band criteria mainly depend on human health categorisation volume, while others mainly depend on the concentration of your chemical when it's introduced into Australia and during its end use. This is a full list of the information you might need to be able to work out your human health exposure band:

  • Human health categorisation volume (needed for scenario 1 of Exposure Band 2, scenario 1 of Exposure Band 3 and Exposure Band 4)
  • Concentration of your chemical at introduction (needed for Exposure Band 1, scenario 2 of Exposure Band 2 and scenario 2 of Exposure Band 3).
  • Concentration of your chemical across all end uses (needed for Exposure Band 1, scenario 2 of Exposure Band 2 and scenario 2 of Exposure Band 3).
  • If it has an end use in tattoo inks or personal vaporisers (which are always in human health exposure band 4)
  • If there are any consumer end uses for the chemical introduction (needed for Exposure Band 1 and scenario 2 of Exposure Band 2 and).

We define 'consumer end use' (which we refer to throughout this page) to be where the chemical is made available to the general public, either on its own, with other chemicals or as part of an article.

What's your human health exposure band?

Start with Exposure Band 1 and work down the page.

Note, if your introduction has an end use in tattoo inks or personal vaporisers, it will be in exposure band 4.

Exposure band 1 criteria

To be in exposure band 1, your introduction must meet all of the criteria:

  • The concentration of your chemical at introduction IS LESS than 0.1 % 
  • The concentration IS LESS than 0.1 % across all your introduction’s end uses 
  • The introduction is NOT for any consumer end use

If your introduction meets all criteria, go to Step 4.4 to work out the human health hazard characteristics of your introduction

If your introduction does not meet all criteria, go to Exposure band 2.

Exposure band 2 criteria

To be in exposure band 2, your introduction must be at least 1 of these scenarios:

Scenario 1

  • The human health categorisation volume for your chemical does not exceed 25kg.

Scenario 2

  • The concentration of your chemical at introduction is less than 0.1 % and
  • The concentration is less than 0.1 % across all your introduction’s end uses and
  • The introduction has at least 1 consumer end use

If your introduction meets the criteria, go to Step 4.4 to work out the human health hazard characteristics of your introduction.

If your introduction does not meet the criteria, go to Exposure Band 3.

Exposure band 3 criteria

To be in exposure band 3, your introduction must be at least 1 of these scenarios:

Scenario 1

  • The human health categorisation volume for your chemical does not exceed 100kg.

Scenario 2

  • The concentration of your chemical at introduction is less than or equal to 1% and
  • The concentration is less than or equal to 1% across all your introduction’s end uses

If your introduction meets the criteria, go to Step 4.4 to work out the human health hazard characteristics of your introduction.

If your introduction does not meet the criteria, go to Exposure Band 4.

Exposure band 4 criteria

Reminder about tattoo inks or personal vaporisers: If you're introducing a chemical with an end use in tattoo inks or personal vaporisers you are automatically in Exposure Band 4 for human health. If this is your introduction type, go to Step 4.4: Work out your human health hazard characteristics.

If the human health categorisation volume of your introduction is greater than 100kg, your introduction is in exposure band 4.

Next: Step 4.4 Work out your human health hazard characteristics

Work out your human health categorisation volume

This page accompanies Step 4.3 work out your human health exposure band. You might need to know the human health categorisation volume (HHCV) of your introduction to work out its human health exposure band. Information on this page tells you when you need to work out a HHCV and when you don't.

 

Explore our categorisation tool for help on this subject

Are you introducing a chemical with an end use in TATTOO INKS or PERSONAL VAPORISERS? If you are, your introduction is automatically in exposure band 4 for human health — go to Step 4.4: Work out your human health hazard characteristics.

Use this guidance to calculate your introduction's human health categorisation volume.

Instructions

  • We've included the equations to use and the options you have to choose from, dependent on the scenarios of your introduction.
  • You can adopt a simple method or a more detailed method (which can result in a lower introduction volume than the simpler method).
  • Once you have worked out your human health categorisation volume, you can complete step 4.3.

When you need to work out a HHCV for your chemical

You need to do this if you want to use an exposure band scenario in step 4.3 that includes HHCV as part of the criteria. This could be if you introduce and use the chemical at relatively high concentrations (> 1%).

When you do not need to work out a HHCV for your chemical

You don’t need to work out a HHCV if:

  • you want to use an exposure band scenario in step 4.3 that does not include HHCV as part of the criteria. This could be if the concentration of your chemical when it’s introduced and during its end use is low (concentrations ≤1% or concentrations <0.1%, depending on the exposure band scenario that applies)
  • it has an end use in tattoo inks or personal vaporisers

Methods you can use to work out a HHCV for your chemical

There are 2 ways to work out the human health categorisation volume.

Method 1: Simplest approach

Use this method if you want an easy way to work out your human health exposure band.

HHCV calculation for this approach

The HHCV is your chemical’s total introduction volume in a registration year for all end uses.

Method 2: More detailed approach

Use this method if you want a more refined human health categorisation volume. Using this method could result in an HHCV that is lower than the total introduction volume in a year. This could mean that your introduction ends up being in a lower human health exposure band than if the total introduction volume (method 1) had been used.

The calculation of the HHCV using method 2 is different depending on whether your chemical introduction has only 1 end use or more than 1 end use.

If your introduction has 1 end use

For a chemical with only 1 end use, calculate the HHCV by multiplying the introduction volume (IV) by the exposure reduction factor (ERF) for your chemical’s end use scenario:

Equation (1): HHCV = IV x ERF

The introduction volume you should use in your calculation is the total introduction volume in a registration year. Use the exposure reduction factor that applies to your end use scenario (see Table for ERFs for different end uses).

The ERF values range between 0 and 1. A low exposure reduction factor indicates that only a small portion of the introduction volume is likely to contribute to human exposure. A higher exposure reduction factor indicates that a higher proportion of the introduction volume could contribute to human exposure.

Exposure reduction factors (ERFs) for different end use scenarios

Your introduction's end use scenario ERF to use
Chemical imported into Australia; import containers remain closed; then exported for end use overseas 0
Chemical imported into Australia; limited handling of the chemical (such that import containers are opened); then exported for end use overseas 0.05
Chemical manufactured in Australia; exported for end use overseas 0.05
Specified consumer products with end use in Australia* 1
All other end uses in Australia 0.1

Note *Specified consumer products means any of the following products:

  • cosmetics
  • nasal sprays
  • ear sprays
  • intimate lubricants
  • massage oils and gels
  • products applied to the nails to harden, or deter the biting of, nails

Specified consumer products do not include tattoo inks and personal vaporisers. If your chemical has an end use in tattoo inks or personal vaporisers, its introduction will be in human health exposure band 4 and you do not need to calculate a HHCV for it.

If your introduction has more than 1 end use

You can choose from 2 options to calculate the HHCV where your chemical has more than one end use

Option 1: Simplest approach

Use this option if:

  • you do not know the annual introduction volume of your chemical for each end use
  • you want to simplify the process of working out your human health exposure band but still want a more refined human health categorisation volume

HHCV calculation for this approach

Allocate the total introduction volume to the end use scenario that has the highest exposure reduction factor (from the table), and use Equation (1) to calculate the HHCV. Note: do not just use the volume for one of the end uses.

Option 2: More detailed approach

Use option 2 if:

  • you know the annual introduction volume of your chemical for each end use
  • you are willing to keep track of any changes to your introduction volume for each end use. This is needed to make sure that the indicative human health risk of your introduction does not increase.

HHCV calculation for this approach

Calculate a separate human health categorisation volume for each of your end uses. Use the exposure reduction factor for the end use (from the table), and the volume that you will be introducing for that end use. Do this for all of your end uses and then add them up to get your total human health categorisation volume (use equation (2) below).

HHCV = (IV1 x ERF1) + (IV2 x ERF2) +… + (IVn x ERFn)

Note: IVn = the introduction volume for end use ‘n’

ERFn = the exposure reduction factor (ERF) for end use ‘n’.

Go back to step 4.3

Step 4.4 Work out your human health hazard characteristics

To work out the human health hazard characteristics your chemical does and does not have, you must know your human health exposure band (Step 4.3). The information you need to consider hazard characteristics varies depending on your introduction’s exposure band.

Important! Your starting point is always hazard band C (the highest hazard band)
Then work your way down the hazard bands as far as you need to get to your outcome (that is, C then B then A). After reading this page, go to human health hazard band C hazard characteristics.

You must have permission to use information that you relied on to demonstrate the absence of hazard characteristics. If we ask you for the information that you relied on to categorise your introduction, you need to provide us with the detailed information, including full study reports, of the kind we specify in this step to demonstrate the absence of the hazard characteristics. 

Hazard characteristics in human health hazard bands

A chemical has a human health hazard characteristic if the chemical can cause damage, harm or adverse effects to humans. For example, a chemical that has the 'skin corrosion' hazard characteristic can cause irreversible damage to the skin of humans.

Human health hazard characteristics are split up into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A.

Our pages for human health hazard bands C, B and A describe hazard characteristics (eg carcinogenicity and so on) in each hazard band and the information you need to have to prove your chemical does not have a particular hazard characteristic.

Information you need and hazard characteristics you need to consider

This varies depending on your introduction’s human health exposure band.

If your introduction is in a lower exposure band

Generally, in the lower exposure bands, where the level of exposure to humans is relatively low, as a minimum you have to consider only a few hazard characteristics and you don’t need much information on them.

If your introduction is in a higher exposure band

In comparison, in higher exposure bands, where the level of exposure to humans is higher, generally you’ll need to consider more hazard characteristics and need more information on them. 

Information you need for lower indicative risk

You will need more hazard information to be able to get to lower indicative risk outcomes. Generally, within any given human health exposure band you need:

  • less hazard information to get to medium to high risk
  • more hazard information to get to low risk
  • the most hazard information to get to very low risk

See Step 4.5 for more information about indicative human health risk outcomes

Where to start and when you can stop considering your chemical's hazard characteristics

Starting point — is always hazard band C.  Always start in the highest hazard band (hazard band C) and work your way down the hazard bands as far as you need to get to your outcome (that is, C then B then A).

You must consider each hazard characteristic in the hazard band you are in (unless there is a reason for you to stop sooner) — does your chemical have that hazard characteristic or not?

When you might not need to consider all of the hazard bands

  • Because your introduction’s human health exposure band (which you worked out in step 4.3) doesn’t require it. For example, if your introduction’s human health exposure band is 1, you only need to consider the hazards in hazard band C to get to an indicative human health risk of either low or very low.
  • Because the outcome for indicative human health risk that you are trying to get to doesn’t require it. For example, if your introduction’s human health exposure band is 3 and you want to get to an indicative human health risk of low, you only need to consider the hazard characteristics in human health hazard band C.

In many cases, you’ll only need to consider hazard band C. But in other cases you might need to consider C, B and A, because your introduction is in exposure band 3 or 4 and you are trying to get to very low indicative human health risk.

See step 4.5 for more about indicative human health risk outcomes

When you can stop working through your chemical’s human health hazard characteristics

Stop if you:

  • determine that your chemical has a hazard characteristic in the hazard band (eg carcinogenicity — you are in hazard band C) or
  • cannot demonstrate that your chemical does not have a certain hazard characteristic in that hazard band. This means that we consider your chemical to have this hazard characteristic or
  • get to an indicative human health risk outcome and don’t want to go any further — see step 4.5 for more information about human health risk outcomes or
  • have demonstrated that your chemical does not have any hazard characteristics in hazard bands C, B and A. This would only be needed for human health exposure bands 3 and 4. It means that the indicative human health risk of your introduction is very low.

After you stop, you don’t need to consider the remaining hazard characteristics in the hazard band where you stopped, or any of the hazard characteristics in lower hazard bands. Take note of where and why you stopped, then move to step 4.5.

Example: Anna's introduction is in human health exposure band 4. She considers all of the hazard characteristics in human health hazard band C and can demonstrate that her chemical does not have any of these hazards. Anna then moves on to hazard band B. She works through the hazard characteristics in this hazard band in the order that they are shown in the table. When Anna comes to eye damage, she finds that her chemical has the 'eye damage' hazard characteristic. This means Anna can stop there. The indicative human health risk of Anna's introduction is medium to high. She does not need to continue further to see if her chemical has any of the other hazard characteristics in hazard band B, like skin sensitisation, or specific target organ toxicity after repeated exposure. Also Anna doesn't need to consider if her chemical has any of the hazard characteristics in hazard band A, such as skin irritation.

How to consider each hazard characteristic

Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it does meet the hazard characteristic definition, stop there and move to step 4.4.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic.

Our pages on hazard bands C, B and A describe hazard characteristics and the ways to prove that your chemical does not have a hazard characteristic. 

How to prove that your chemical does not have a hazard characteristic

You can read about your options to prove that your chemical does not have a particular hazard characteristic on each human health hazard band page. These options include

  • checking if your chemical is on the list of chemicals with high hazards for categorisation
  • in silico predictions
  • in vitro test results 
  • in vivo test results
  • suitable read-across information in place of information on the chemical itself 
  • other information about your chemical that means that testing and in silico predictions are not necessary (that is, information waivers)

If you have access to existing information on the chemical or suitable read-across information, you should consider these first. If you need to generate new data to prove the absence of a hazard characteristic, you should choose non-animal test data when possible. You should only generate new animal test data as a last resort.

See our section on use of animal test data

If you can prove that your chemical does not have the hazard characteristic, move on to the next hazard characteristic in that hazard band, or from the next hazard band down.

If you cannot prove that your chemical does not have the hazard characteristic, stop there – your chemical is considered to have this hazard characteristic. Take note of the hazard band that this hazard characteristic is in and move on to step 4.5.

If your chemical is one of these:

there may be different requirements for you to prove that your chemical does not have certain hazard characteristics. 

Human health hazard band C hazard characteristics – using our list of chemicals with high hazards for categorisation

In most cases we do not expect that you will have information about the high level hazard characteristics in human health hazard band C, such as carcinogenicity. Instead, to demonstrate that your chemical does not have these hazard characteristics you can search the list of chemicals with high hazards for categorisation. This is a list that we have compiled directly from trusted international sources, and provides you with a single place to search for your chemical to check if it might be known to have these hazards. Our hazard band pages tell you when you might need to search the high hazards list.

A list of resources to help you with this step

Human health hazard bands - what are the hazard characteristics in each hazard band

These pages describe the hazard characteristics in each hazard band and the information you need to have to prove your chemical does not have a particular hazard characteristic. Follow instructions on each of these pages. Always start with hazard band C.

Human health hazard band C hazard characteristics

This page accompanies step 4.4 Work out your human health hazard characteristics.

Do not start this page unless you have read Step 4.4 Work out your human health hazard characteristics

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. 

Hazard band C has 5 hazard characteristics you need to consider:

  • carcinogenicity
  • reproductive toxicity
  • developmental toxicity
  • adverse effects mediated by an endocrine mode of action 
  • genetic toxicity

Instructions

You must always start at hazard band C. Step 4.4 tells you when you can stop working through your chemical's human health hazard characteristics and when you need to check each of them - ie C, B and A.

Work your way through each hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have. 

If it does meet the hazard characteristic definition, stop there - your introduction's human health hazard band is C. Move on to the next step - step 4.5 Work out your human health risk for categorisation

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s human health hazard band is C. Move onto the next step – step 4.5 Work out your human health risk for categorisation

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page. 

After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, decide whether you can stop there or continue to human health hazard band B. This depends on the exposure band of your introduction. 

If your introduction is in human health exposure band 1 or 2, stop here - you don’t need to consider any other hazard characteristics. Next go to step 4.5 to work out your human health risk for categorisation.

If your introduction is in human health exposure band 3 you can choose to stop (and go to step 4.5 to work out your human health risk for categorisation), or to continue to human health hazard band B and then A. 

If your introduction is in human health exposure band 4, continue to human health hazard band B

 


Carcinogenicity

Carcinogenicity means that any of the following apply to the industrial chemical: 

  • the chemical is a known, presumed or suspected human carcinogen, as described in chapter 3.6 of the GHS, with the chemical classified as carcinogenicity (category 1 or 2), or 
  • the chemical (or the chemical of which it is an ester or salt) is on the list of chemicals with high hazards for categorisation based on its carcinogenicity, or
  • an in vivo study on the chemical conducted following an acceptable test guideline for carcinogenicity, chronic toxicity, subchronic oral toxicity, subchronic dermal toxicity or subchronic inhalation toxicity results in the induction of cancer, or an increase in the incidence of cancer. 

Information required to demonstrate the absence of the hazard characteristic, carcinogenicity  

  • Confirmation that the chemical (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its carcinogenicity.
  • In addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter, information is required to justify why the chemical would not cause carcinogenicity mediated by exposure to UV light. This may include one or more of the following:
    • the chemical has a molar extinction/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
    • results from in vitro phototoxicity studies, or 
    • results from in vivo carcinogenicity studies where the methods have been modified to include photoactivation. 
 

Reproductive toxicity

Reproductive toxicity means that any of the following apply to the industrial chemical: 

  • the chemical is known, presumed or suspected to produce adverse effects on sexual function and fertility, as described in chapter 3.7 of the GHS, with the chemical classified as toxic to reproduction (category 1 or 2), or 
  • the chemical (or the chemical of which it is an ester or salt) is on the list of chemicals with high hazards for categorisation based on its reproductive toxicity, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for reproductive toxicity, carcinogenicity, chronic toxicity, subchronic oral toxicity, subchronic dermal toxicity or subchronic inhalation toxicity results in adverse effects on sexual function and fertility, as described in chapter 3.7 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, reproductive toxicity  

  • If the chemical is a polyhalogenated organic chemical and the human health exposure band for the introduction is 4
    • an in vivo test result on the chemical or suitable read across information conducted following an acceptable test guideline for reproductive toxicity, which results in none of the adverse effects on sexual function or fertility described in chapter 3.7 of the GHS;
  • Otherwise – 
    • confirmation that the chemical (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its reproductive toxicity.
 

Developmental toxicity

Developmental toxicity means that any of the following apply to the industrial chemical:

  • the chemical is known, presumed or suspected to produce adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS, with the chemical classified as follows: 
    • toxic to reproduction (category 1 or 2), or 
    • effects on or via lactation, or 
    • the chemical (or the chemical of which it is an ester or salt) is on the list of chemicals with high hazards for categorisation based on its developmental toxicity, or
    • an in vivo study on the chemical conducted following an acceptable test guideline for developmental toxicity or reproductive toxicity results in adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, developmental toxicity

  • If the chemical is a polyhalogenated organic chemical and the human health exposure band for the introduction is 4 – 
    • an in vivo test result on the chemical or suitable read across information conducted following an acceptable test guideline for developmental toxicity or reproductive toxicity which results in none of the adverse effects on the development of the offspring or effects on the offspring via lactation, as described in chapter 3.7 of the GHS
  • Otherwise – 
    • confirmation that the chemical (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its developmental toxicity.
 

Adverse effects mediated by an endocrine mode of action

Adverse effects of mediated by an endocrine mode of action means that any of the following apply to the industrial chemical: 

  • the chemical meets all of the following: 
    • it shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or lifespan of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in the susceptibility to other influences, and 
    • it has an endocrine activity, which is the capacity to alter the function(s) of the endocrine system, and 
    • the adverse effect is a consequence of the endocrine activity

or

  • the chemical (or the chemical of which it is an ester or salt) is on the list of chemicals with high hazards for categorisation, based on its adverse effects mediated by an endocrine mode of action or 
  • the chemical meets all of the following: 
    • information is available that is relevant to determining whether the chemical has the hazard characteristic, adverse effects mediated by an endocrine mode of action, and 
    • the information has been considered in a weight of evidence analysis based on the following guidance documents: 
      • the EU guidance for identifying endocrine disruptors, and 
      • the guidance provided in OECD GD 150; and 
    • the weight of evidence analysis concludes that the chemical has the hazard characteristic, adverse effects mediated by an endocrine mode of action. 

Information required to demonstrate the absence of the hazard characteristic, adverse effects mediated by an endocrine mode of action

  • If the chemical has existing information relevant to determining whether it has the hazard characteristic, adverse effects mediated by an endocrine mode of action, information is required to demonstrate that the chemical does not have this hazard characteristic: 
    • this must involve a documented weight of evidence analysis based on the EU guidance for identifying endocrine disruptors* and the guidance in OECD GD 150**, and 
    • the analysis must conclude that the chemical does not have the hazard characteristic, adverse effects mediated by an endocrine mode of action.
  • Otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, adverse effects mediated by an endocrine mode of action, is confirmation that the chemical (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its adverse effects mediated by an endocrine mode of action.

*Guidance for the identification of endocrine disruptors in the context of 39 Regulations (EU) No 528/2012 and (EC) No 1107/2009, currently a 2017 consultation draft. 

**ENV/JM/MONO(2012)22, OECD Series on Testing and Assessment, No. 150 - Guidance document on standardised test guidelines for evaluating chemicals for endocrine disruption.

 

Genetic toxicity

Genetic toxicity means that any of the following apply to the industrial chemical: 

  • the chemical is known to induce or may induce mutations in the germ cells of humans, as described in chapter 3.5 of the GHS, with the chemical classified as germ cell mutagenicity (category 1 or 2), or 
  • the chemical (or the chemical of which it is an ester or salt) is on the list of chemicals with high hazards for categorisation, based on its genetic toxicity, or 
  • an in vitro study on the chemical:
    • conducted following an acceptable test guideline for gene mutation or chromosomal abnormalities results in the prediction of mutagenic or genotoxic effects, as described in chapter 3.5 of the GHS, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for gene mutation, chromosomal abnormalities or heritable germ cell mutagenicity, or 
    • an in vivo study on the chemical conducted following an acceptable test guideline for gene mutation, chromosomal abnormalities or heritable germ cell mutagenicity results in mutagenic or genotoxic effects, as described by chapter 3.5 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, genetic toxicity

The information required to demonstrate that a chemical does not have the hazard characteristic, genetic toxicity, is: 

  • if the human health exposure band for the introduction is 4 - at least one of the following: 
    • information to demonstrate that the chemical is included on the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • information to demonstrate that the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, and that the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
    • information to demonstrate that the chemical is a high molecular weight polymer, and if you are seeking to demonstrate that the introduction meets the criteria for very low risk and is not one of the 'special cases' mentioned in step 4.5 - test results from an in vitro study on the polymer or from suitable read across information conducted following an acceptable test guideline for gene mutation, which demonstrates the absence of mutagenic effects, or 
    • test results that demonstrate the absence of mutagenic or genotoxic effects from both: 
      • study on the chemical or from suitable read across information conducted following an acceptable test guideline for gene mutation, and 
      • study on the chemical or from suitable read across information conducted following an acceptable test guideline for chromosomal abnormalities. 
    • if the human health exposure band for the introduction is 3, and you are seeking to demonstrate that the introduction meets the criteria for very low risk and is not one of the 'special cases' mentioned in step 4.5 - at least one of the following: 
      • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
      • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
      • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or
      • if the polymer is a high molecular weight polymer, test results from an in vitro study on the polymer or from suitable read across information conducted following an acceptable test guideline for gene mutations, which demonstrates the absence of mutagenic effects, or 
      • information that demonstrates the absence of mutagenic or genotoxic effects from both: 
        • information on the chemical or from suitable read across information that addresses gene mutations - this could be: 
          • a suitable in silico prediction, both with and without metabolic activation, or 
          • test results from a study conducted following an acceptable test guideline for gene mutations; and
        • test results from a study on the chemical or from suitable read across information conducted following an acceptable test guideline for chromosomal abnormalities.
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, genetic toxicity, is confirmation that the chemical (or the chemical of which it is an ester or salt) is not on the list of chemicals with high hazards for categorisation, based on its genetic toxicity. 
  • in addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter, information is required to justify why the chemical would not cause genetic toxicity mediated by UV light. This may include one or more of the following: 
    • the chemical has a molar extinction coefficient/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
    • results from in vitro phototoxicity studies, or 
    • results from in vitro or in vivo genetic toxicity studies where the methods have been modified to include photoactivation.
       

 

Human health hazard band B hazard characteristics

This page accompanies step 4.4 Work out your human health hazard characteristics

 

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. You must always start at hazard band CStep 4.4 tells you when you can stop working through your chemical's human health hazard characteristics and when you need to check each of them - ie C, B and A.

Hazard band B has 9 hazard characteristics you need to consider:

  • High molecular weight polymer that is water absorbing
  • Respiratory sensitisation
  • Corrosive to the respiratory tract
  • Specific target organ toxicity and a single exposure (significant toxicity)
  • Skin corrosion
  • Eye damage
  • Skin sensitisation
  • Acute toxicity (fatal or toxic)
  • Specific target organ toxicity after repeated exposure

Instructions

You must always start at hazard band C. 

You only need to work through the hazard characteristics on this page if your introduction is in: 

  • human health exposure band 3, and you are trying to get to an outcome of very low indicative human health risk or 
  • human health exposure band 4, and you are trying to get to an outcome of low or very low indicative human health risk.

Work your way through each hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have.

If it does meet the hazard characteristic definition, stop there - your introduction's human health hazard band is B. Move on to the next step - step 4.5 Work out your human health risk for categorisation.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s human health hazard band is B. Move onto the next step – step 4.5 Work out your human health risk for categorisation.

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page. 
After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, decide whether you can stop there or continue to human health hazard band A This depends on the exposure band of your introduction. 

If your introduction is in human health exposure band 3, continue to human health hazard band A. 

If your introduction is in human health exposure band 4, you can choose to stop (and go to step 4.5 to work out your human health risk for categorisation), or continue to human health hazard band A.


High molecular weight polymer that is water absorbing

High molecular weight polymer that is water absorbing means that all of the following apply to the industrial chemical: 

  • it is a high molecular weight polymer, and 
  • it has a number average molecular weight that is greater than or equal to 10,000 g/mol, and 
  • it is capable of absorbing its own weight, or more, in water, and 
  • it contains particles with a particle size less than 10 micrometres (microns).

Information required to demonstrate the absence of the hazard characteristic, high molecular weight polymer that is water absorbing 

If the chemical is a high molecular weight polymer, the information required to demonstrate that it does not have the hazard characteristic, high molecular weight polymer that is water absorbing, is at least one of: 

  • molecular weight information that demonstrates the number average molecular weight (NAMW) is less than 10,000 g/mol, or 
  • information that demonstrates that the polymer is not introduced in a particulate form, or 
  • particle size information that demonstrates that the particle size is greater than or equal to 10 micrometres (microns), or
  • information that demonstrates that the polymer does not absorb its own weight or more in water, such as experiments that show that it does not form a gel in water, or that if it does, the gel dissolves upon addition of more water.

Respiratory sensitisation

Respiratory sensitisation means that any of the following apply to the industrial chemical: 

  • the chemical is known or presumed to produce hypersensitivity of the airways in humans, as described in chapter 3.4 of the GHS, with the chemical classified as respiratory sensitisation (category 1), or 
  • the chemical is named: 
    • on the EU SVHC Candidate list for authorisation, based on respiratory sensitising properties (https://echa.europa.eu/candidate-list-table), or 
    • in the Danish EPA (Q)SAR Database as a predicted respiratory sensitiser (http://qsar.food.dtu.dk/), or 
    • the chemical is an enzyme, or 
    • the chemical is a polymer that contains one or more free isocyanate groups, or 
    • an in vivo study on the chemical indicates hypersensitivity of the airways, as discussed in chapter 3.4 of the GHS, or 
    • an in vitro study on the chemical: 
      • indicates hypersensitivity of the airways, as discussed in chapter 3.4 of the GHS, and 
      • the result of the study has not been negated by in vivo studies conducted on the chemical for hypersensitivity of the airways.

Information required to demonstrate the absence of the hazard characteristic, respiratory sensitisation  

There are no information requirements to demonstrate the absence of the hazard characteristic, respiratory sensitisation. If you do not have any information that demonstrates that the chemical has this hazard characteristic then you can assume it does not for the purposes of categorisation.


Corrosive to the respiratory tract

Corrosive to the respiratory tract means that any of the following apply to the industrial chemical: 

  • the chemical is known to cause destruction of the respiratory tract tissue, as described in chapter 3.1 of the GHS, with the chemical classified as corrosive to the respiratory tract (AUH071 - non-GHS hazard statement), or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for acute inhalation toxicity, subacute inhalation toxicity or subchronic inhalation toxicity results in destruction of the respiratory tract, as described in chapter 3.1 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, corrosive to the respiratory tract  

There are no information requirements to demonstrate the absence of the hazard characteristic, corrosive to the respiratory tract. If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation.


Specific target organ toxicity after a single exposure (significant toxicity)

Specific target organ toxicity after a single exposure (significant toxicity) means that any of the following apply to the industrial chemical: 

  • the chemical is known or presumed to produce significant toxicity in humans, as described in chapter 3.8 of the GHS, with the chemical classified as specific target organ toxicity – single exposure (category 1), or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at less than or equal to 300 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at less than or equal to 1,000 mg/kg bw, or
    • conducted following an acceptable test guideline for acute inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS:
      • gases - less than or equal to 2,500 ppmV/4h, or 
      • vapours -  less than or equal to mg/L/4h, or 
      • for dusts/mists/fumes - less than or equal to 1 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (significant toxicity) 

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (significant toxicity). If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation.
 


Skin corrosion

Skin corrosion means that any of the following apply to the industrial chemical: 

  • the chemical is known to produce irreversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as skin corrosion (category 1), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for skin corrosion results in the prediction of skin corrosion effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for skin irritation results in destruction of skin tissue, as described for skin corrosion in chapter 3.2 of the GHS, or 
  • the chemical is a pyrophoric liquid or a pyrophoric solid, as described in chapters 2.9 and 2.10 of the GHS respectively. 

Information required to demonstrate the absence of the hazard characteristic, skin corrosion  

The information required to demonstrate that a chemical does not have the hazard characteristic, skin corrosion, is at least one of the following: 

  • information that demonstrates that the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups: 
    • anhydride, or
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or 
  • information that demonstrates that the chemical is a high molecular weight polymer that contains any of the following reactive functional groups and the polymer has a combined functional group equivalent weight of greater than or equal to 1,000 g/mol: 
    • anhydride, or 
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or 
  • if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to skin or has no alerting groups for skin irritation, or 
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin corrosion, with a non-corrosive prediction, or 
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, with a non-irritant prediction, or 
  • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, which does not result in destruction of skin tissue, as described for skin corrosion in chapter 3.2 of the GHS.

Eye damage

Eye damage means that any of the following apply to the industrial chemical: 

  • the chemical is known to produce serious eye damage, as described in chapter 3.3 of the GHS, with the chemical classified as eye damage (category 1), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for eye damage results in the prediction of serious eye damage effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for eye irritation results in effects on the eye, as described for serious eye damage in chapter 3.3 of the GHS, or 
  • the chemical is a pyrophoric liquid or a pyrophoric solid, as described in chapters 2.9 and 2.10 of the GHS, respectively. 

Information required to demonstrate the absence of the hazard characteristic, eye damage 

The information required to demonstrate that a chemical does not have the hazard characteristic, eye damage, is at least one of the following: 

  • information that demonstrates that the chemical is a high molecular weight polymer that does not contain any of the following reactive functional groups: 
    • anhydride, or 
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or
  • information that demonstrates that the chemical is a high molecular weight polymer that contains any of the following reactive functional groups with a combined functional group equivalent weight of greater than or equal to 1,000 g/mol: 
    • anhydride, or 
    • epoxide, or 
    • sulfonic acid, or 
    • amine, or 
  • if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the eye, or 
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye damage, which predicts the chemical would not induce serious eye damage 
  • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye irritation, which does not result in effects on the eye, as described for eye damage in chapter 3.3 of the GHS.

Skin sensitisation 

Skin sensitisation means that any of the following apply to the industrial chemical: 

  • the chemical is known to cause an allergic response following skin contact, as described in chapter 3.4 of the GHS, with the chemical classified as skin sensitisation (category 1), or 
  • human testing or epidemiological studies on the chemical result in evidence of an allergic response, as described in chapter 3.4 of the GHS, or 
  • an in vitro study on the chemical: 
    • conducted following an acceptable test guideline for skin sensitisation, results in the prediction of skin sensitisation effects, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for skin sensitisation, or 
  • an in chemico study on the chemical: 
    • conducted following an acceptable test guideline for skin sensitisation, results in the prediction of skin sensitisation effects, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for skin sensitisation, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for skin sensitisation, results in the induction of an allergic response, as described in chapter 3.4 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, skin sensitisation  

  • There are no information requirements to demonstrate the absence of the hazard characteristic, skin sensitisation, if the chemical is corrosive to the skin (GHS category 1) as the in vivo tests cannot be conducted 
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, skin sensitisation, is at least one of the following:  
    • information that demonstrates that the chemical is a high molecular weight polymer for which at least one of the following: 
      • contains only low concern reactive functional groups, or 
      • contains only low concern reactive functional groups and unsubstituted positions ortho and para to phenolic hydroxyl groups, or  
      • contains only reactive functional groups it contains are unsubstituted positions ortho and para to phenolic hydroxyl groups, or 
      • contains only low and moderate concern reactive functional groups , with a combined functional group equivalent weight of greater than or equal to 1000 g/mol, or 
      • it contains only moderate concern reactive functional groups, with a combined functional group equivalent weight of greater than or equal to 1000 g/mol, or 
      • has a number average molecular weight that is greater than or equal to 10,000 g/mol and both: 
        • less than 2% by mass of molecules with molecular weight that is less than 500 g/mol, and 
        • less than 5% by mass of molecules with molecular weight that is less than 1,000 g/mol, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V, of the REACH Regulation, or 
    • if the human health exposure band is 3 - all of the following: 
      • suitable in silico prediction indicating that the chemical and its metabolites (if any) do not cause skin sensitisation, and 
      • results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 2nd key event in skin sensitisation, with a non-sensitising prediction, and 
      • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 3rd key event in skin sensitisation, with a non-sensitising prediction, or 
    • all of the following: 
      • test results from an in chemico test on the chemical or from suitable read-across information, conducted following an acceptable test guideline for the 1st key event in skin sensitisation, with a non-sensitising prediction, and 
      • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 2nd key event in skin sensitisation, with a non-sensitising prediction, and 
      • results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 3rd key event in skin sensitisation, with a non-sensitising prediction
    • test results from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for skin sensitisation, which does not result in induction of an allergic response, as described in chapter 3.4 of the GHS 
  • in addition, if the human health exposure band for the introduction is 4 and the chemical is a UV filter or is introduced for an end use in a tattoo ink, information is required to justify why the chemical would not cause skin sensitisation mediated by UV light. This may include one or more of the following : 
    • the chemical has a molar extinction coefficient/absorption coefficient of less than or equal to 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
    • results from in vitro phototoxicity studies, or 
    • results from in vitro or in vivo skin sensitisation studies where the methods have been modified to include photoactivation.

Low concern reactive functional groups - see our polymer of low concern criteria page.

Moderate concern reactive functional groups - see our polymer of low concern criteria page. 


Acute toxicity (fatal or toxic) 

Acute toxicity (fatal or toxic) means that any of the following apply to the industrial chemical: 

  • the chemical is known to exhibit acute toxicity effects, as described in chapter 3.1 of the GHS, with the chemical classified as acute toxicity (category 1 or 2 or 3), or
  • an in vitro study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity, results in a predicted acute oral toxicity LD50 value of less than or equal to 300 mg/kg bw, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for acute toxicity, or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity results in an acute oral LD50 value of less than or equal to 300 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute dermal toxicity results in an acute dermal LD50 value of less than or equal to 1,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute inhalation toxicity results in an acute inhalation LC50 value of:
      • for gases - less than or equal to 2,500 ppmV/4h, or 
      • for vapours - less than or equal to 10 mg/L/4h, or 
      • for dusts/mists/fumes - less than equal to 1 mg/L/4h , or 
  • evidence in humans of systemic toxicity after eye contact, with the chemical classified with the non-GHS hazard statement – AUH070, or 
  • an in vivo study, conducted following an acceptable test guideline for eye irritation, results in overt signs of systemic toxicity or mortality, which is likely to be attributed to absorption of the chemical through the mucous membranes of the eye, with the chemical classified with the non-GHS hazard statement – AUH070.

Information required to demonstrate the absence of the hazard characteristic, acute toxicity (fatal or toxic) 

  • there are no information requirements to demonstrate the absence of the hazard characteristic, acute toxicity (fatal or toxic), if the chemical is corrosive to the skin (GHS category 1), or likely to be corrosive to the skin (that is, the chemical is a strong acid (pH less than or equal to 2.0) or base (pH greater than or equal to 11.5), and has high buffering capacity (if relevant)), as the in vivo tests cannot be conducted
  • if the chemical is for end use in a personal vaporiser - the information required to demonstrate that the chemical does not have the hazard characteristic, acute toxicity (fatal or toxic), is a test result from at least one in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for acute inhalation toxicity with an LC50: 
    • for gases -  greater than 2,500 ppmV/4h, or 
    • for vapours - greater than 10 mg/L/4h, or 
    • for dusts/mists/fumes - greater than 1 mg/L/4h, or 
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, acute toxicity (fatal or toxic), is at least one of the following: 
    • if the human health exposure band for the introduction is 3 - both of the following: 
      • a suitable in silico prediction for acute toxicity (LD50) of the chemical of greater than 2,000 mg/kg bw/day, and 
      • test results from an in vitro study on the chemical or from suitable read across information for acute toxicity (LD50), conducted following an acceptable test guideline for acute oral toxicity, of greater than 300 mg/kg bw,  or 
    • information that demonstrates that the chemical is a high molecular weight polymer that has:
      • less than 5% by mass of molecules with molecular weight less than 1,000 g/mol, and 
      • less than 2% by mass of molecules with molecular weight less than 500 g/mol, or 
    • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • the chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
    • a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available): 
      • conducted following an acceptable test guideline for acute oral toxicity with an LD50 greater than 300 mg/kg bw, or
      • conducted following an acceptable test guideline for acute dermal toxicity with an LD50 greater than 1,000 mg/kg bw, or 
      • conducted following an acceptable test guideline for acute inhalation toxicity, with an LC50: 
        • for gases -  greater than 2,500 ppmV/4h, or
        • for vapours - greater than 10 mg/L/4h, or 
        • for dusts/mists/fumes - greater than 1 mg/L/4h, or 
    • test results from an in vivo study via the oral route on the chemical or from suitable read across information, conducted following an acceptable test guideline for subacute oral toxicity, with a NOAEL greater than or equal to 1,000 mg/kg bw/day.

Specific target organ toxicity after repeated exposure

Specific target organ toxicity after repeated exposure means that any of the following apply to the industrial chemical:

  • the chemical is known to exhibit significant toxicity or be potentially harmful to human health following repeated exposure, as described in chapter 3.9 of the GHS, with the chemical classified as specific target organ toxicity – repeated exposure (category 1 or 2), or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for subacute oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (oral) value of less than 300 mg/kg bw/day, or 
    • conducted following an acceptable test guideline for subchronic oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (oral) of less than 100 mg/kg bw/day, or 
    • conducted following an acceptable test guideline for subacute dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (dermal) value of less than 600 mg/kg bw/day, or
    • conducted following an acceptable test guideline for subchronic dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEL (dermal) of less than 200 mg/kg bw/day, or 
    • conducted following an acceptable test guideline for subacute inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEC (inhalation) of: 
      • for gases - less than 750 ppmV/6 h/day, or
      • for vapours - less than 3 mg/L/6 h/day, or 
      • for dusts/mists/fumes less than 0.6 mg/L/6 h/day, or 
    • conducted following an acceptable test guideline for subchronic inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, and a NOAEC (inhalation) of: 
      • for gases - less than 250 ppmV/6 h/day, or 
      • for vapours - less than 1 mg/L/6 h/day, or
      • for dusts/mists/fumes less than 0.2 mg/L/6 h/day.

Information required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after repeated exposure  

Information is required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after repeated exposure, if: 

  • the human health exposure band for the introduction is 4, and 
  • you are seeking to demonstrate that the introduction meets the criteria for low risk or very low risk 

and any of the following apply: 

  1. the human health categorisation volume for the introduction is greater than 100 kg and the chemical is introduced for end use in any of the following types of articles: 
    • food contact, or
    • children’s toys that can be placed in the mouth, or 
    • children’s care products that can be placed in the mouth, or 
  2. the human health categorisation volume for the introduction is greater than 1000 kg and the chemical is not introduced for end use in any of the following types of articles: 
    • food contact, or 
    • children’s toys that can be placed in the mouth, or 
    • children’s care products that can be placed in the mouth, or

3.    the chemical is for end use in a personal vaporiser.

See extra guidance on categorisation of chemicals:

If 1 or 2 apply, the information required to demonstrate that a chemical does not have the hazard characteristic, specific target organ toxicity after repeated exposure, is at least one of the following: 

  • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • the chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
  • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
  • information that demonstrates that the chemical is a high molecular weight polymer that does not have the hazard characteristic, skin corrosion, or 
  • a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available): 
    • conducted following an acceptable test guideline for subacute oral toxicity, in which the NOAEL (oral) is greater than or equal to 300 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subchronic oral toxicity, in which the NOAEL (oral) is greater than or equal to 100 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subacute dermal toxicity, in which the NOAEL (dermal) is greater than or equal to 600 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subchronic dermal toxicity, in which the NOAEL (dermal) is greater than or equal to 200 mg/kg bw/day or there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or 
    • conducted following an acceptable test guideline for subacute inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is: 
      • for gases - greater than or equal to 750 ppmV/6 h/day, or 
      • for vapours - greater than or equal to 3 mg/L/6 h/day, or 
      • for dusts/mists/fumes - greater than or equal to 0.6 mg/L/6 h/day , or 
    • conducted following an acceptable test guideline for subchronic inhalation toxicity, in which there were no significant toxic effects of relevance to human health (as described in chapter 3.9 of the GHS) produced, or the NOAEC (inhalation) is: 
      • for gases - greater than or equal to 250 ppmV/6 h/day, or 
      • for vapours - greater than or equal to 1 mg/L/6 h/day, or 
      • for dusts/mists/fumes - greater than or equal to 0.2 mg/L/6 h/day.

If 3 applies (the chemical is for end use in a personal vaporiser), the information required to demonstrate that the chemical does not have the hazard characteristic, specific target organ toxicity after repeated exposure, is a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below: 

  • conducted following an acceptable test guideline for subacute inhalation toxicity, in which there were no significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, or the NOAEC (inhalation) is: 
    • for gases - greater than or equal to 750 ppmV/6 h/day, or 
    • for vapours - greater than or equal to 3 mg/L/6 h/day, or 
    • for dusts/mists/fumes - ≥ 0.6 mg/L/6 h/day, or
  • conducted following an acceptable test guideline for subchronic inhalation toxicity, in which there were no significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, or the NOAEC (inhalation) is: 
    • for gases - greater than or equal to 250 ppmV/6 h/day, or 
    • for vapours - greater than or equal to 1 mg/L/6 h/day, or 
    • for dusts/mists/fumes - greater than or equal to 0.2 mg/L/6 h/day.

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after repeated exposure, if: 

  • the human health exposure band for the introduction is 4, and 
  • you are seeking to demonstrate that the introduction meets the criteria for low risk or very low risk, 

and any of the following apply: 

  • the human health categorisation volume for the introduction is less than or equal to 100 kg and the chemical is introduced for end use in any of the following types of articles: 
    • food contact, or
    • children’s toys that can be placed in the mouth, or
    • children’s care products that can be placed in the mouth, or 
  • the human health categorisation volume for the introduction is less than or equal to 1,000 kg and the chemical is not introduced for end use in any of the following types of articles:
    • food contact, or 
    • children’s toys that can be placed in the mouth, or 
    • children’s care products that can be placed in the mouth

In these circumstances, if you do not have any information that demonstrates that the chemical has this hazard characteristic then you can assume it does not for the purposes of categorisation.

Human health hazard band A hazard characteristics

This page accompanies step 4.4 Work out your human health hazard characteristics.

 

Human health hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band C, while those of lower concern are in hazard band A. 

Hazard band A has 6 hazard characteristics you need to consider:

  • High molecular weight polymer that has lung overloading potential
  • Aspiration hazard
  • Specific target organ toxicity after a single exposure (harmful or transient effects)
  • Skin irritation
  • Eye irritation
  • Acute toxcity (harmful)

Instructions

You must always start at hazard band C. You only need to work through the hazard characteristics on this page if your introduction is in: 

  • human health exposure band 3, and you are trying to get to an outcome of very low indicative human health risk or 
  • human health exposure band 4, and you are trying to get to an outcome of very low indicative human health risk.

Work your way through each hazard characteristic on this page. Look at whether your chemical meets the hazard characteristic definition based on the information that you have. 

If it does meet the hazard characteristic definition, stop there - your introduction's human health hazard band is A.

Move on to the next step - step 4.5 Work out your human health risk for categorisation.

If it does not meet the hazard characteristic definition, you’ll need to try and prove that your chemical does not have this hazard characteristic. The information that you need to prove this for each hazard characteristic is shown below. If you do not have this information, stop there - your introduction’s human health hazard band is A.

Move onto the next step – step 4.5 Work out your human health risk for categorisation.

If you do have this information (so you can prove that the chemical does not have the hazard characteristic), move onto the next hazard characteristic on this page. 

After you have considered all the hazard characteristics on this page and have proven that the chemical does not have any of them, go to step 4.5 to work out your human health risk for categorisation).


High molecular weight polymer that has lung overloading potential

High molecular weight polymer that has lung overloading potential means that all of the following apply to the industrial chemical: 

  • it is a polymer, and 
  • it has a number average molecular weight that is greater than 70,000 g/mol, and 
  • it has a solubility in water of less than 0.1 mg/L, and 
  • it becomes aerosolised during end use.

Information required to demonstrate the absence of the hazard characteristic, high molecular weight polymer that has lung overloading potential  

If the chemical is a polymer, the information required to demonstrate that a chemical does not have the hazard characteristic, high molecular weight polymer that has lung overloading potential, is at least one of the following: 

  • molecular weight information that demonstrates that the number average molecular weight is less than or equal to 70,000 g/mol, or 
  • information that demonstrates that the polymer has a solubility in water that is greater than or equal to 0.1 mg/L measured following an acceptable test guideline for water solubility, or 
  • information that demonstrates that the polymer does not become aerosolised during end use

Aspiration hazard

Aspiration hazard means that any of the following apply to the industrial chemical:

  • the chemical is known or presumed to cause aspiration toxicity, as described in chapter 3.10 of the GHS, with the chemical classified as may be fatal if swallowed and enters airways (category 1), or 
  • the chemical is a hydrocarbon that has a kinematic viscosity less than or equal to 20.5 mm2/s, measured at 40°C.

Information required to demonstrate the absence of the hazard characteristic, aspiration hazard  

  • If the chemical is a hydrocarbon, the information required to demonstrate the absence of the hazard characteristic, aspiration hazard, is a measured kinematic viscosity greater than a20.5 mm2/s, at 40°C 
  • Otherwise, there are no information requirements to demonstrate the absence of the hazard characteristic, aspiration hazard. If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation.

Specific target organ toxicity after a single exposure (harmful or transient effects)

Specific target organ toxicity after a single exposure (harmful or transient effects) means that any of the following apply to the industrial chemical: 

  • the chemical is known or presumed to be harmful to humans or to cause transient target organ effects, as described in chapter 3.8 of the GHS, with the chemical classified as specific target organ toxicity-single exposure (category 2 or 3), or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at greater than 300 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute dermal toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at greater than 1,000 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute inhalation toxicity results in significant toxic effects of relevance to human health, as discussed in chapter 3.8 of the GHS, at: 
      • for gases -  greater than 2,500 but less than or equal to 20,000 ppmV/4h, or 
      • for vapours -  greater than 10 but less than or equal to 20 mg/L/4h, or 
      • for dusts/mists/fumes -  greater than 1 but less than or equal to 5 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (harmful or transient effects)  

There are no information requirements to demonstrate the absence of the hazard characteristic, specific target organ toxicity after a single exposure (harmful or transient effects). If you do not have any information that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation. 


Skin irritation 

Skin irritation means that any of the following apply to the industrial chemical: 

  • the chemical is known to produce reversible damage to the skin, as described in chapter 3.2 of the GHS, with the chemical classified as skin irritation (category 2), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for skin irritation results in the prediction of skin irritation effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for skin irritation results in skin reactions, as described for skin irritation (category 2) in chapter 3.2 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, skin irritation  

The information required to demonstrate that a chemical does not have the hazard characteristic, skin irritation, is at least one of the following: 

  • if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the skin, or 
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, with a non-irritant prediction, or 
  • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for skin irritation, which does not result in skin reactions, as described for skin irritation in chapter 3.2 of the GHS, or 
  • test results from an in vivo study on the chemical or from suitable read across information conducted following an acceptable test guideline for acute dermal toxicity, that when tested at 2,000 mg/kg bw/day is not irritating to the skin.

In addition, if the chemical is introduced for an end use in a tattoo ink, information is required to justify why the chemical would not cause skin irritation mediated by UV light. This may include one or more of the following: 

  • the chemical has a molar extinction coefficient/absorption coefficient of less than 1,000Lmol-1cm-1 at wavelengths between 290 and 700nm (based on the results of a study following OECD test guideline 101), or 
  • results from in vitro phototoxicity studies, or  
  • results from in vitro or in vivo irritation studies where the methods have been modified to include photoactivation.

Eye irritation

Eye irritation means that any of the following apply to the industrial chemical: 

  • the chemical is known to produce changes in the eye, as described in chapter 3.3 of the GHS, with the chemical classified as eye irritation (category 2), or 
  • an in vitro study on the chemical conducted following an acceptable test guideline for eye irritation results in the prediction of eye irritation effects, or 
  • an in vivo study on the chemical conducted following an acceptable test guideline for eye irritation results in changes in the eye, as described for eye irritation in chapter 3.3 of the GHS.

Information required to demonstrate the absence of the hazard characteristic, eye irritation  

The information required to demonstrate that a chemical does not have the hazard characteristic, eye irritation, is at least one of the following: 

  • if the human health exposure band for the introduction is 3 - a suitable in silico prediction indicating that the chemical is not irritating to the eyes, or 
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye damage or eye irritation with a non-irritant prediction, or 
  • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for eye irritation, which does not result in changes in the eyes, as described for eye irritation (category 2) in chapter 3.3 of the GHS. 

Acute toxicity (harmful) 

Acute toxicity (harmful) means that any of the following apply to the industrial chemical: 

  • the chemical is known to exhibit acute toxicity effects, as described in chapter 3.1 of the GHS, with the chemical classified as acute toxicity (category 4), or 
  • an in vitro study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity, results in a predicted acute toxicity LD50 value of greater than 300 but less than or equal to 2,000 mg/kg bw, and 
    • the results of the study have not been negated by in vivo studies conducted on the chemical for acute toxicity, or 
  • an in vivo study on the chemical: 
    • conducted following an acceptable test guideline for acute oral toxicity results in an acute oral LD50 value of greater than 300 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute dermal toxicity results in an acute dermal LD50 value of greater than 1,000 but less than or equal to 2,000 mg/kg bw, or 
    • conducted following an acceptable test guideline for acute inhalation toxicity results in an acute inhalation LC50 value of: 
      • for gases -  greater than 2500 but less than or equal to 20,000 ppmV/4h, or 
      • for vapours - greater than 10 but less than or equal to 20 mg/L/4h, or 
      • for dusts/mists/fumes - greater than 1 but less than or equal to 5 mg/L/4h.

Information required to demonstrate the absence of the hazard characteristic, acute toxicity (harmful)  

  • if the chemical is for end use in a personal vaporiser - the information required to demonstrate that the chemical does not have the hazard characteristic, acute toxicity (harmful), is a test result from at least one in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for acute inhalation toxicity with an LC50 of: 
    • for gases - greater than 20,000 ppmV/4h, or 
    • for vapours - greater than 20 mg/L/4h, or 
    • for dusts/mists/fumes - greater than 5 mg/L/4h, or 
  • otherwise, the information required to demonstrate that a chemical does not have the hazard characteristic, acute toxicity (harmful), is at least one of the following: 
    • if the human health exposure band for the introduction is 3 -  both of the following: 
      • a suitable in silico prediction for acute toxicity (LD50) of the chemical of greater than 2,000 mg/kg bw/day, and 
      • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for acute oral toxicity, with a predicted LD50 of greater than 2,000 mg/kg bw, or 
    • information that demonstrates that the chemical is a high molecular weight polymer that has: 
      • less than than 5% by mass of molecules with molecular weight less than 1,000 g/mol, and 
      • less than 2% by mass of molecules with molecular weight less than 500 g/mol 
    • inclusion of the chemical in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • the chemical has been notified to the US FDA GRAS notification program and FDA had no questions about the notifier’s conclusion of GRAS status, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • the chemical is permitted to be used as a food additive according to Schedule 15 of the Australia New Zealand Food Standards Code - Standard 1.3.1 - Food Additives, as long as the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use, or 
    • information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or 
    • a test result from at least one in vivo study on the chemical or from suitable read across information, as detailed below, with the administration route dependent on the most relevant route of exposure (or the oral route if information on the most relevant route is not available): 
      • conducted following an acceptable test guideline for acute oral toxicity with an LD50  greater than 2,000 mg/kg bw, or 
      • conducted following an acceptable test guideline for acute dermal toxicity with an LD50  greater than 2,000 mg/kg bw, or 
      • conducted following an acceptable test guideline for acute inhalation toxicity with an LC50: 
        • for gases - greater than 20,000 ppmV/4h, or 
        • for vapours - greater than 20 mg/L/4h, or 
        • for dusts/mists/fumes - greater than 5 mg/L/4h, or
    • test results from an in vivo study on the chemical or from suitable read across information, conducted following an acceptable test guideline for subacute oral toxicity, with a NOAEL greater than or equal to 1,000 mg/kg bw/day.

Step 4.5 Outcome - your human health risk for categorisation

The table on this page shows how you can work out your indicative human health risk by using your human health exposure band and the human health hazard characteristics that your chemical does or does not have.

Get help with this step — explore our categorisation decision tools

We explain the table in detail for each human health exposure band that your introduction could be in. This includes what your indicative human health risk outcome will be, depending on which hazard characteristics your chemical does or does not have. Your outcome will be that your introduction has an indicative human health risk of:

  • medium to high
  • low OR
  • very low

Refer back to step 4.4 for information about how to consider the hazard characteristics and where to start and stop when considering hazard characteristics.

Human health risk table

Work out your indicative human health risk Human health exposure band
    1 2 3 4
Human health hazard band C Low risk Medium to high risk Medium to high risk Medium to high risk
B Very low risk Very low risk Low risk Medium to high risk
A Very low risk Very low risk Low risk Low risk
Not C, B, A Very low risk Very low risk Very low risk Very low risk

If your introduction is in human health exposure band 1

If your introduction is in human health exposure band 1, you will need to consider if your chemical has any of the hazard characteristics in human health hazard band C. It’s not necessary to consider the hazard characteristics in band B or A.

The indicative human health risk of your introduction will be:

  • low if your chemical has 1 or more of the hazard characteristics in human health hazard band C OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band C

If your introduction is in human health exposure band 2

If your introduction is in human health exposure band 2, you will need to consider if your chemical has any of the hazard characteristics in human health hazard band C. It’s not necessary to consider the hazard characteristics in band B or A.

The indicative human health risk of your introduction will be:

  • medium to high if your chemical has 1 or more of the hazard characteristics in human health hazard band C OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band C

If your introduction is in human health exposure band 3

If your introduction is in human health exposure band 3, at a minimum, you will need to consider if your chemical has any of the hazard characteristics in human health hazard band C.

The indicative human health risk of your introduction will be:

  • medium to high if your chemical has 1 or more of the hazard characteristics in human health hazard band C OR
  • low if your chemical does not have any of the hazard characteristics in human health hazard band C

You can choose to stop if you get to low indicative human health risk.

If you want to see if your introduction could have a very low indicative human health risk, you will also need to consider if it has any of the hazard characteristics in human health hazard bands B and A.

The indicative human health risk of your introduction will be:

  • low if your chemical has 1 or more of the hazard characteristics in human health hazard band B or A OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band B or A

If your introduction is in human health exposure band 4

If your introduction is in human health exposure band 4, you will first need to consider if your chemical has any of the hazard characteristics in human health hazard band C. If it does not, then continue on to consider the hazard characteristics in human health hazard band B.

The indicative human health risk of your introduction will be:

  • medium to high if your chemical has 1 or more of the hazard characteristics in human health hazard band C or B OR
  • low if your chemical does not have any of the hazard characteristics in human health hazard band C or B

You can choose to stop if you get to low indicative human health risk.

If you want to see if your introduction could have a very low indicative human health risk, you will also need to consider if it has any of the hazard characteristics in human health hazard band A.

The indicative human health risk of your introduction will be:

  • low if your chemical has 1 or more of the hazard characteristics in human health hazard band A OR
  • very low if your chemical does not have any of the hazard characteristics in human health hazard band A

'Special cases' — introductions that CANNOT have a very low indicative human health risk

Your introduction CANNOT have a very low indicative human health risk if it is a:

  • UV filter OR
  • chemical that is introduced as a solid or a dispersion that is not soluble, that meets the nanoscale particle size criteria, and the introduction of the nanoscale portion of the chemical (the part that has a particle size range of 1nm to 100nm) is incidental to the introduction of the non-nanoscale portion

If your introduction is 1 of these, and you got a very low risk outcome in this step, you need to CHANGE that outcome to LOW RISK.

This means if your consideration of step 4.5 got you to an outcome of very low risk, your final outcome needs to be changed to low risk.

Definitions of these 'special cases'

UV filter is a chemical that is intended to protect the skin against ultraviolet radiation in the range of 290nm to 400nm by absorption, reflection, or scattering of ultraviolet radiation.

Nanoscale particle size criteria means that the chemical consists of particles in an unbound state or as an aggregate or agglomerate. At least 50% (by number size distribution) of the particles must have at least 1 external dimension in the particle size range of 1nm to 100nm (i.e. the nanoscale).

Not soluble means the solubility of the chemical in water is less than 33.3 g/L measured following OECD test guidelines 105 or 120 for water solubility; or the dissolution rate of the chemical is not more than 70%.

Next

Go to step 5 to work out the risk to the environment of your introduction