Step 5.4 Work out your environment 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 environment hazard bands
A chemical has an environment hazard characteristic if the chemical can cause damage, harm or adverse effects to the environment. For example, a chemical that has the 'toxic to any aquatic life' hazard characteristic can cause toxic injury to an organism following short term aquatic exposure.
Environment hazard characteristics are split up into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.
See links below to each of the hazard bands: D, C, B and A.
Our pages for environment hazard bands D, C, B and A describe hazard characteristics (eg toxic to any aquatic life 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 environment exposure band.
If your introduction is in a lower exposure band
Generally, in the lower exposure bands, where the level of exposure to the environment 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 the environment 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 environment 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 5.5 for more information about indicative environment risk outcomes
Where to start and when you can stop considering your chemical's hazard characteristics
Always start in the highest hazard band (hazard band D) and work your way down the hazard bands as far as you need to get to your outcome (that is, D, 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 environment exposure band (which you worked out in step 5.3) doesn’t require it. For example, if your introduction’s environment exposure band is 2, you only need to consider the hazards in hazard band D to get to an indicative environment risk of either medium to high or low.
- Because the outcome for indicative environment risk that you are trying to get to doesn’t require it. For example, if your introduction’s environment exposure band is 3 and you want to get to an indicative environment risk of low, you only need to consider the hazard characteristics in environment hazard bands D and C.
In many cases, you’ll only need to consider hazard band D. But in other cases you might need to consider D, C, B and A because your introduction is in exposure band 3 or 4 and you are trying to get to very low indicative environment risk.
See step 5.5 for more about indicative environment risk outcomes
When you can stop working through your chemical’s environment hazard characteristics
Stop if you:
- determine that your chemical has a hazard characteristic in the hazard band (e.g. persistent, bioaccumulative and toxic - you are in hazard band D) 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 environment risk outcome and don’t want to go any further - see step 5.5 for more information about environment risk outcomes or
- have demonstrated that your chemical does not have any hazard characteristics in hazard bands D, C, B and A . This would only be needed for environment exposure bands 3 and 4. It means that the indicative environment 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 and move on to step 5.5.
Example: Rosemary's introduction is in environment exposure band 4. She considers all of the hazard characteristics in environment hazard band D and can demonstrate that her chemical does not have any of these hazards. Rosemary then moves on to hazard band C. She works through the hazard characteristics in this hazard band in the order that they are shown in the table. When Rosemary comes to 'very toxic to any aquatic life', she finds that her chemical has this hazard characteristic. This means Rosemary can stop there. The indicative environment risk of Rosemary's introduction is medium to high. She does not need to continue further to see if her chemical has the other hazard characteristic in hazard band C (persistent and bio-accumulative). Also Rosemary doesn't need to consider if her chemical has any of the hazard characteristics in hazard bands B or A.
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 5.5.
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 D, 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 environment 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. 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.
Resources to help you with this step
We refer to the following throughout this step:
- List of chemicals with high hazards for categorisation
- In silico information - an overview of which human health (4.4) and environment characteristics have in silico options and which in silico models are appropriate.
You can also check our glossary for the definition of in silico. - Acceptable test guidelines for each environment hazard characteristic in this step
- Suitable read across information
- Decision tools for step 5.4 (self-guided tools to help you categorise your introduction)
- hazard characteristics for environment exposure band 1, hazard characteristics for environment exposure band 2, hazard characteristics for environment exposure band 3, hazard characteristics for environment exposure band 4 - use this tool if your introduction is in this exposure band
To work out the environment characteristics your chemical does and does not have, you must know your environment exposure band (Step 5.3). The information you need to consider hazard characteristics varies depending on your introduction’s exposure band.
Environment hazard bands - what are the hazard characteristics in each hazard band?
The following 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 D.
Environment hazard band D hazard characteristics
Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.
Hazard band D has 5 hazard characteristics you need to consider:
- Contains arsenic, cadmium, lead or mercury
- Ozone depleting chemical
- Synthetic greenhouse gas
- Adverse effects mediated by an endocrine mode of action
- Persistent, bioaccumulative and toxic
Instructions
You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - ie D, C, B and A.
Work your way through 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 environment hazard band is D. Move on to the next step - step 5.5 Work out your environment 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 environment hazard band is D. Move onto the next step – step 5.5 Work out your environment 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 environment hazard band C. This depends on the exposure band of your introduction.
If your introduction is in environment exposure band 1 or 2, you can choose to stop (and go to step 5.5 to work out your environment risk for categorisation), or to continue to environment hazard band C.
If your introduction is in environment exposure band 3 or 4, continue to environment hazard band C.
Hazard characteristics and required information
Contains arsenic, cadmium, lead or mercury
Contains arsenic, cadmium, lead or mercury means that the industrial chemical contains one or more of the following:
- arsenic
- cadmium
- lead or
- mercury
There are no extra information requirements to prove that the chemical does not have this hazard characteristic.
Ozone depleting chemical
Ozone depleting chemical means that any of the following apply to the industrial chemical:
- the chemical is controlled under the Ozone Protection and Synthetic Greenhouse Gas Management Act 1989, or
- the chemical is controlled under the Montreal Protocol on Substances that Deplete the Ozone Layer.
Synthetic greenhouse gas
Synthetic greenhouse gas means that any of the following apply to the industrial chemical:
- the chemical is controlled under the Ozone Protection and Synthetic Greenhouse Gas Management Act 1989, or
- the chemical is listed on the Kyoto Protocol, Synthetic Greenhouse Gases under Annex A, or
- the chemical is controlled under the Montreal Protocol on Substances that Deplete the Ozone Layer.
Adverse effects mediated by an endocrine mode of action
Adverse effects 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 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 is an ester or a salt of a chemical that is listed in the table below, which are on the list of chemicals with high hazards for categorisation based on adverse effects mediated by an endocrine mode of action unless an exception, as identified in the table below, is met for that chemical,
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 Revised Guidance Document 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 is not on the list of chemicals with high hazards for categorisation, based on its adverse effects mediated by an endocrine mode of action and
- Confirmation that the chemical is not an ester or salt of the specified chemicals shown in the table below, which are on the list of chemicals with high hazards for categorisation, based on adverse effects mediated by an endocrine mode of action.
Adverse effects mediated by an endocrine mode of action - exception criteria
Check the following table - an ester or salt of the chemical has the adverse effects mediated by an endocrine mode of action hazard characteristic, unless one or more of the following exception criteria apply.
| CAS number | Chemical name | An ester or salt of the chemical has the adverse effects mediated by an endocrine mode of action hazard characteristic, unless one or more of the below exception criteria apply |
|---|---|---|
| 80-05-7 | Phenol, 4,4'-(1-methylethylidene)bis- (Bisphenol A) |
|
| 80-09-1 | Phenol, 4,4'-sulfonylbis- (Bisphenol S) |
|
| 98-54-4 | Phenol, 4-(1,1-dimethylethyl)- |
|
| 80-46-6 | Phenol, 4-(1,1-dimethylpropyl)- |
|
| Various | Heptylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers |
|
| Various | Octylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers |
|
| Various | Nonylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers |
|
| Various | Dodecylphenols on the list of chemicals with high hazards for categorisation – includes linear and branched isomers |
|
| Various | Octyl and Nonylphenol ethoxylates on the list of chemicals with high hazards for categorisation | No exceptions |
Note – Low levels of low molecular weight species (in relation to a polymer) means less than 10% (by mass) of molecules with a molecular weight that is less than 500 g/mol and less than 25% (by mass) of molecules with a molecular weight that is less than 1,000 g/mol.
Persistent, bioaccumulative and toxic
Your introduction is in environment hazard band D if any of the following apply to the industrial chemical:
- the chemical is on the list of chemicals with high hazards for categorisation, based on it being persistent, bioaccumulative and toxic, or
- all of the following apply:
- the chemical is persistent (see our glossary definition)
- the chemical is bioaccumulative, and
- the chemical has the hazard characteristic, very toxic to any aquatic life
For the purposes of this hazard characteristic, bioaccumulative means any of the following apply to the chemical:
- it has a bioaccumulation factor (BAF) greater than or equal to 2000 for the aquatic compartment, or
- it has a bioconcentration factor (BCF) greater than or equal to 2000 for the aquatic compartment, or
- it has a measured log Kow greater than or equal to 4.2 for the aquatic compartment (unless a measured BAF or BCF is less than 2000), or
- it has a log Koa greater than 6 and log Kow greater than or equal to 2 for the terrestrial compartment, or
- it has a biomagnification factor (BMF) greater than 1.
Information required to demonstrate that a chemical does not have the hazard characteristic, persistent, bioaccumulative and toxic
Confirmation that the chemical is not on the list of chemicals with high hazards for categorisation based on it being persistent, bioaccumulative and toxic. In addition, if the environment exposure band for the introduction is 2 (and you are seeking to demonstrate that the introduction meets the criteria for very low risk and it is not the 'special cases' mentioned in step 5.5), or 3, or 4, the information required to demonstrate that a chemical does not have the hazard characteristic, persistent, bioaccumulative and toxic, is at least one of the following:
- information that demonstrates that the chemical is an inorganic chemical, or
- information to demonstrate that the chemical is a biological chemical, or
- information that demonstrates that the chemical has a molecular weight that is greater than 1,000 g/mol, or
- information that demonstrates that the chemical is a high molecular weight polymer with:
- less than 25% low molecular weight oligomeric species less than 1,000g/mol, and
- less than 10% low molecular weight oligomeric species less than 500g/mol, or
- information that demonstrates that the chemical has a solubility in water that is greater than 5g/L, measured following an acceptable test guideline for water solubility, or
- information that demonstrates that the chemical is a gas that is not expected to partition to the aquatic compartment, or
- information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or
- a suitable in silico prediction for partition coefficient of the chemical itself of log Kow less than 4.2 (that is not negated by a measured log Kow), or
- measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient, for which log Kow less than 4.2, or
- if the chemical is not a highly branched organic chemical* – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
- tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or
- tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or
- tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or
- a test result from a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
- tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or
- tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or
- tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or
- if the chemical is not a highly branched organic chemical* – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both:
- a degradation half-life in water of less than 2 months, and
- a degradation half-life in sediment of less than 6 months, or
- a test result from a study on the chemical, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both:
- a degradation half-life in water of less than 2 months, and
- a degradation half-life in sediment of less than 6 months, or
- if the chemical is not a biocidal active and not a persistent, highly branched organic chemical** – information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with at least one of the following results for all 3 trophic levels:
- acute aquatic toxicity greater than 1 mg/L (96h LC50 (fish), or 48h EC50 (invertebrates) or 72 or 96h ErC50 (algae)), or
- chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are not readily biodegradable), or
- chronic aquatic toxicity NOEC or EC10 > 0.01 mg/L (for chemicals that are readily biodegradable), or
- test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with a NOEC or EC10 greater than 0.1mg/L for all 3 trophic levels, or
- a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioconcentration, for which the BCF less than 2,000, or
- a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioaccumulation, for which the BAF less than 2,000.
*If the chemical is a highly branched organic chemical, in silico predictions and read across information cannot be used to demonstrate that the chemical does not have the persistence aspect of the persistent, bioaccumulative and toxic hazard characteristic – only studies on the chemical itself, as described in the next dot point, are acceptable
**If the chemical is a biocidal active or a persistent, highly branched organic chemical, in silico predictions cannot be used to demonstrate that the chemical does not have the toxicity aspect of the persistent, bioaccumulative and toxic hazard characteristic – only in vivo chronic aquatic toxicity studies, as described in the next dot point, are acceptable.
This page accompanies step 5.4 Work out environment hazard characteristics.
Environment hazard band C hazard characteristics
Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.
Hazard band C has 2 hazard characteristics you need to consider:
- very toxic to any aquatic life
- persistent and bioaccumlative - environment hazard band C
Instructions
You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - ie D, C, B and A.. You only need to work through the hazard characteristics on this page is your introduction is in:
- Environment exposure band 1 or 2 and you are trying to get to an outcome of very low indicative environment risk or
- Environment exposure band 3 or 4
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 environment hazard band is C. Move on to the next step - step 5.5 Work out your environment 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 environment hazard band is C. Move onto the next step – step 5.5 Work out your environment 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 environment hazard band B. This depends on the exposure band of your introduction.
If your introduction is in environment exposure band 1, stop here – you don’t need to consider any other hazard characteristics. Next go to step 5.5 to work out your environment risk for categorisation.
If your introduction is in environment exposure band 2, continue to environment hazard band B.
If your introduction is in environment exposure band 3, you can choose to stop here (and go to step 5.5 to work out your environment risk for categorisation, or to continue to environment hazard band B.
If your introduction is in environment exposure band 4, continue to environment hazard band B.
This page accompanies step 5.4 Work out environment hazard characteristics.
Very toxic to any aquatic life
Very toxic to any aquatic life means that any of the following apply to the industrial chemical:
- the chemical is known to cause:
- toxic injury to an organism following short term aquatic exposure as described in chapter 4.1 of the GHS, with the chemical classified as acute aquatic toxicity (category 1), or
- adverse effects to an organism during aquatic exposures determined in relation to the life-cycle of the organism, as described in chapter 4.1 of the GHS, with the chemical classified as chronic aquatic toxicity (category 1), or
- the chemical is on the list of chemicals with high hazards for categorisation based on it being very toxic to any aquatic life, or
- an in vivo acute study on the chemical:
- conducted following an acceptable test guideline for acute toxicity to fish results in a 96h LC50 less than or equal to 1 mg/L, or
- conducted following an acceptable test guideline for acute toxicity to invertebrates results in a 48h EC50 less than or equal to 1 mg/L, or
- conducted following an acceptable test guideline for acute toxicity to algae or other aquatic plants results in a 72 or 96h ErC50 less than or equal to 1 mg/L, or
- an in vivo chronic study on the chemical conducted following an acceptable test guideline for chronic toxicity to fish, chronic toxicity to invertebrates, or chronic toxicity to algae or other aquatic plants results in a:
- NOEC or EC10 less than equal to 0.1 mg/L (for chemicals that are not readily biodegradable), or
- NOEC or EC10 less than or equal to 0.01 mg/L (for chemicals that are readily biodegradable), or
- a suitable in silico prediction for acute aquatic toxicity results in a prediction of:
- for fish - 96h LC50 less than or equal to 1 mg/L, or
- for invertebrates - 48h EC50 less than or equal to 1 mg/L, or
- for algae or other aquatic plants - 72 or 96h ErC50 less than or equal to 1 mg/L
and the predictions have not been negated by in vivo studies conducted on the chemical for aquatic toxicity.
Information required to demonstrate the absence of the hazard characteristic, very toxic to any aquatic life
The information required to demonstrate that a chemical does not have the hazard characteristic, very toxic to any aquatic life, is:
- if the exposure band for the introduction is 1 - confirmation that the chemical is not on the list of chemicals with high hazards for categorisation based on it being very toxic to any aquatic life
- if the environment exposure band for the introduction is 2, 3, or 4, - at least one of the following:
- information that demonstrates that the chemical has a molecular weight greater than 1,000g/mol and has a low cationic density, or
- information that demonstrates that the chemical is a high molecular weight polymer that has a low cationic density, or
- information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or
- if the chemical is not a biocidal active and not a persistent, highly branched organic chemical – information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with one of the following results for each of the 3 trophic levels:
- acute aquatic toxicity greater than 1 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae)), or
- chronic aquatic toxicity NOEC or EC10 greater than 0.1 mg/L (for chemicals that are not readily biodegradable), or
- chronic aquatic toxicity NOEC or EC10 greater than 0.01 mg/L (for chemicals that are readily biodegradable), or
- test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all 3 trophic levels:
- NOEC or EC10 greater than 0.1 mg/L (for chemicals that are not readily biodegradable), or
- NOEC or EC10 greater than 0.01 mg/L (for chemicals that are readily biodegradable).
Persistent and bioaccumulative
Persistent and bioaccumulative means that any of the following apply to the industrial chemical:
- the chemical is on the list of chemicals with high hazards for categorisation, based on it being persistent and bioaccumulative, or
- both of the following apply:
- the chemical is persistent, and
- the chemical is bioaccumulative.
For the purposes of this hazard characteristic, bioaccumulative means any of the following apply to the chemical:
- it has a bioaccumulation factor (BAF) greater than OR equal to 2000 for the aquatic compartment, or
- it has a bioconcentration factor (BCF) greater than or equal to 2000 for the aquatic compartment, or
- it has a measured log Kow greater than or equal to 4.2 for the aquatic compartment (unless a measured BCF or BAF is less than 2000), or
- it has a log Koa greater than 6 and log Kow greater than or equal to 2 for the terrestrial compartment, or
- it has a biomagnification factor (BMF) greater than 1.
Information required to demonstrate the absence of the hazard characteristic, persistent and bioaccumulative
The information required to demonstrate that a chemical does not have the hazard characteristic, persistent and bioaccumulative, is confirmation that the chemical is not on the list of chemicals with high hazards for categorisation based on it being persistent and bioaccumulative. In addition, if the environment exposure band for the introduction is 2 (and you are seeking to demonstrate that the introduction meets the criteria for very low risk and it is not the 'special cases' mentioned in step 5.5), or 3 or 4, the information required to demonstrate that a chemical does not have the hazard characteristic, persistent and bioaccumulative, is at least one of the following:
- information that demonstrates that the chemical is an inorganic chemical, or
- to demonstrate that the chemical is a biological chemical, or
- information that demonstrates that the chemical has a molecular weight that is greater than 1,000 g/mol, or
- information that demonstrates that the chemical is a high molecular weight polymer with:
- less than 25% low molecular weight oligomeric species less than 1,000g/mol, and
- less than 10% low molecular weight oligomeric species less than 500g/mol, or
- information that demonstrates that the chemical has a solubility in water that is greater than 5g/L, measured following an acceptable test guideline for water solubility, or
- information that demonstrates that the chemical is a gas that is not expected to partition to the aquatic compartment, or
- a suitable in silico prediction for partition coefficient of the chemical itself of log Kow less than 4.2 (that is not negated by a measured log Kow), or
- a measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient, for which log Kow less than 4.2, or
- if the chemical is not a highly branched organic chemical* – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
- tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or
- tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or
- tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or
- a test result from a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
- tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or
- tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or
- tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or
- if the chemical is not a highly branched organic chemical* – a test result from a study on the chemical or from suitable read across information, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both:
- a degradation half-life in water of less than 2 months, and
- a degradation half-life in sediment of less than 6 months, or
- a test result from the chemical, conducted following an acceptable test guideline for transformation in aquatic sediment systems, results in both:
- a degradation half-life in water of less than 2 months, and
- a degradation half-life in sediment of less than 6 months, or
- a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioconcentration, for which the BCF is less than 2,000, or
- a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioaccumulation, for which the BAF is less than 2,000.
*If the chemical is a biocidal active or a persistent, highly branched organic chemical, in silico predictions cannot be used to demonstrate that the chemical does not have the very toxic to any aquatic life hazard characteristic – only in vivo chronic aquatic toxicity studies, as described in the next dot point, are acceptable.
Environment hazard band B hazard characteristics
Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.
Hazard band B has 1 hazard characteristic you need to consider - toxic to any aquatic life.
Instructions
You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - ie D, C, B and A. You only need to work through the hazard characteristics on this page is your introduction is in:
- Environment exposure band 2 or 3 and you are trying to get to an outcome of very low indicative environment risk or
- Environment exposure band 4
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 environment hazard band is B. Move on to the next step - step 5.5 Work out your environment 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 environment hazard band is B.
Move onto the next step – step 5.5 Work out your environment 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 environment hazard band A. This depends on the exposure band of your introduction.
If your introduction is in environment exposure band 2, stop here – you don’t need to consider any other hazard characteristics. Next go to step 5.5 to work out your environment risk for categorisation.
If your introduction is in environment exposure band 3, continue to environment hazard band A.
If your introduction is in environment exposure band 4, you can choose to stop here (and go to step 5.5 to work out your environment risk for categorisation, or to continue to environment hazard band A.
Toxic to any aquatic life
Toxic to any aquatic life means that any of the following apply to the industrial chemical:
- the chemical is known to cause:
- toxic injury to an organism following short term aquatic exposure as described in chapter 4.1 of the GHS, with the chemical classified as acute aquatic toxicity (category 2), or
- adverse effects to an organism during aquatic exposures determined in relation to the life-cycle of the organism, as described in chapter 4.1 of the GHS, with the chemical classified as chronic aquatic toxicity (category 2), or
- an in vivo acute study on the chemical:
- conducted following an acceptable test guideline for acute toxicity to fish results in a 96h LC50 greater than 1mg/L but less than or equal to 10mg/L, or
- conducted following an acceptable test guideline for acute toxicity to invertebrates results in a 48h EC50 greater than 1mg/L but less than or equal to 10mg/L, or
- conducted following an acceptable test guideline for acute toxicity to algae or other aquatic plants results in a 72 or 96h ErC50 greater than 1mg/L but less than or equal to 10mg/L, or
- an in vivo chronic study on the chemical conducted following an acceptable test guideline for chronic toxicity to fish, chronic toxicity to invertebrates, or chronic toxicity to algae or other aquatic plants results in a:
- NOEC or EC10 greater than 0.1mg/L but less than or equal to 1mg/L (for chemicals that are not readily biodegradable), or
- NOEC or EC10 greater than 0.01mg/L but less than or equal to 0.1mg/L (for chemicals that are readily biodegradable), or
- a suitable in silico prediction for acute aquatic toxicity results in a prediction of:
- for fish - 96h LC50 greater than 1mg/L but less than or equal to 10mg/L, or
- for invertebrates - 48h EC50 greater than 1mg/L but less than or equal to 10mg/L, or
- for algae or other aquatic plants - 72 or 96h ErC50 greater than 1mg/L but less than or equal to 10mg/L, or
and the predictions have not been negated by in vivo studies conducted on the chemical for aquatic toxicity.
Information required to demonstrate the absence of the hazard characteristic, toxic to any aquatic life
The information required to demonstrate that a chemical does not have the hazard characteristic, toxic to any aquatic life, is at least one of the following:
- information that demonstrates that the chemical has a molecular weight greater than 1,000 g/mol and has a low cationic density, or
- information that demonstrates that the chemical is a high molecular weight polymer that has a low cationic density, or
- information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or
- if the chemical is not a biocidal active and not a persistent, highly branched organic chemical – information on aquatic toxicity for all three trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with the following results for all three trophic levels:
- acute aquatic toxicity greater than 10 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae)), or
- chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that are not readily biodegradable), or
- chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable), or
- test results for all three trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all three trophic levels:
- NOEC or EC10 greater than 1mg/L (for chemicals that are not readily biodegradable), or
- NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable).
This page accompanies step 5.4 Work out environment hazard characteristics.
Environment hazard band A hazard characteristics
This page accompanies step 5.4 Work out environment hazard characteristics.
Environment hazard characteristics are split into hazard bands. Hazard characteristics of most concern are in hazard band D, while those of lower concern are in hazard band A.
Hazard band A has 6 hazard characteristics you need to consider:
- Contains aluminium, chromium, copper, nickel, selenium, silver or zinc
- Polymer that does not have a low cationic density
- Polymer that is not stable
- Bioaccumulation potential
- Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability
- Harmful to any aquatic life
Instructions
You must always start at hazard band D. Step 5.4 tells you when you can stop working through your chemical's environment hazard characteristics and when you need to check each of them - that is, D, C, B and A. You only need to work through the hazard characteristics on this page is your introduction is in:
- Environment exposure band 3 or 4 and you are trying to get to an outcome of very low indicative environment 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 environment hazard band is A. Move on to the next step - step 5.5 Work out your environment 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 environment hazard band is A. Move onto the next step – step 5.5 Work out your environment 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 5.5 to work out your environment risk for categorisation.
Links to resources to help you with the following:
- Read-across information
- Acceptable test guidelines for categorisation
- In silico predictions for categorisation
Hazard characteristics and required information
Contains aluminium, chromium, copper, nickel, selenium, silver or zinc
Contains aluminium, chromium, copper, nickel, selenium, silver or zinc means that the industrial chemical contains one or more of the following:
- aluminium
- chromium
- copper
- nickel
- selenium
- silver
- zinc
There are no extra information requirements to prove that the chemical does not have this hazard characteristic.
Polymer that does not have a low cationic density
Polymer that does not have a low cationic density means that the industrial chemical is a polymer that does not meet the definition of low cationic density.
There are no extra information requirements to prove that the chemical does not have this hazard characteristic.
Polymer that is not stable
Polymer that is not stable means that all of the following apply to the industrial chemical:
- the chemical is a polymer, and
- the polymer substantially degrades, decomposes or depolymerises during use; that is, the polymer is considerably, meaningfully or to a significantly large extent, changed into simpler, smaller molecular weight chemicals as the result of processes including, but not limited to:
- oxidation
- hydrolysis
- heat
- sunlight
- attack by solvents
Information required to demonstrate the absence of the hazard characteristic, polymer that is not stable
The information required to demonstrate that a chemical does not have the hazard characteristic, polymer that is not stable, is at least one of the following:
- information that demonstrates that the polymer is protected from degradation by being encapsulated during use, or
- information that demonstrates that all of the following applies to the polymer:
- it is not designed to be pyrolysed or burnt, and
- it is not designed or reasonably anticipated to substantially photodegrade, and
- it is not designed or reasonably anticipated to substantially biodegrade, and
- it is not explosive, and
- it is hydrolytically stable (T½ greater than or equal to 12 hours), and
- it is not a biological polymer, and
- it is not a polysaccharide, and
- if it is a polymer that contains polyethylene glycol (PEG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade, and
- if it is a polymer that contains polypropylene glycol (PPG) functionalities and has a solubility in water of greater than 200 mg/L - measured data demonstrates that the polymer does not substantially biodegrade.
Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability
Industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability, means that a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, results in at least one of the following, as relevant to the test method used, and within the period specified in the test method:
- less than or equal to 70% dissolved organic carbon (DOC) removal, or
- less than or equal to 60% theoretical carbon dioxide, or
- less than or equal to 60% theoretical oxygen demand.
Information required to demonstrate the absence of the hazard characteristic, industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability
The information required to demonstrate that a chemical does not have the hazard characteristic, industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability, is at least one of the following:
- information that demonstrates that the chemical is highly volatile and it is expected to predominately partition to the air compartment, or
- information that demonstrates that it is an inorganic chemical, or
- information that demonstrates that it is a biological chemical, or
- if the chemical is not a highly branched organic chemical* – a test result from a study on the chemical or suitable read across information, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
- tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or
- tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide
- tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand, or
- a test result from a study on the chemical, conducted following an acceptable test guideline for ready biodegradability, which meets at least one of the following degradation pass levels during the period specified in the test method:
- tests based on dissolved organic carbon (DOC) - greater than or equal to 70% DOC removal, or
- tests based on carbon dioxide generation - greater than or equal to 60% theoretical carbon dioxide, or
- tests based on oxygen depletion - greater than or equal to 60% theoretical oxygen demand.
*If the chemical is a highly branched organic chemical, in silico predictions and read across information cannot be used to demonstrate that the chemical does not have the hazard characteristic, industrial chemical (other than a polymer) that does not meet the criteria for ready biodegradability – only studies on the chemical itself, as described in the next dot point, are acceptable.
Harmful to any aquatic life
Harmful to any aquatic life means that any of the following apply to the industrial chemical:
- the chemical is known to cause:
- toxic injury to an organism following short term aquatic exposure , as described in chapter 4.1 of the GHS, with the chemical classified as acute aquatic toxicity (category 3), or
- adverse effects to an organism during aquatic exposures determined in relation to the life-cycle of the organism, as described in chapter 4.1 of the GHS, with the chemical classified as chronic aquatic toxicity (category 3 or 4), or
- an in vivo acute study on the chemical:
- conducted following an acceptable test guideline for acute toxicity to fish results in a 96h LC50 greater than 10mg/L but less than or equal to 100mg/L, or
- conducted following an acceptable test guideline for acute toxicity to invertebrates results in a 48h EC50 greater than 10mg/L but less than or equal to 100mg/L, or
- conducted following an acceptable test guideline for acute toxicity to algae or other aquatic plants results in a 72 or 96h ErC50 greater than 10mg/L but less than or equal to 100mg/L, or
- an in vivo chronic study on the chemical conducted following an acceptable test guideline for chronic toxicity to fish, chronic toxicity to invertebrates, or chronic toxicity to algae or other aquatic plants results in a:
- NOEC or EC10 greater than 0.1mg/L but less than or equal to 1mg/L (for chemicals that are readily biodegradable), or
- a suitable in silico prediction for acute aquatic toxicity results in a prediction of:
- for fish - 96h LC50 greater than 10mg/L but less than or equal to 100mg/L, or
- for invertebrates - 48h EC50 greater than 10mg/L but less than or equal to 100mg/L, or
- for algae or other aquatic plants - 72 or 96h ErC50 greater than 10mg/L but less than or equal to100mg/L.
and the predictions have not been negated by in vivo studies conducted on the chemical for aquatic toxicity.
Information required to demonstrate that a chemical does not have the hazard characteristic, harmful to any aquatic life
At least one of the following:
- information that demonstrates that the chemical has a molecular weight greater than 1,000g/mol and has a low cationic density, or
- information that demonstrates that the chemical is a high molecular weight polymer that has a low cationic density, or
- information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation, or
- if the chemical is not a biocidal active and not a persistent, highly branched organic chemical – information on aquatic toxicity for all three trophic levels (fish, invertebrates and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with the following results for all three trophic levels:
- acute aquatic toxicity greater than 100 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae)), or
- chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that are readily biodegradable), or
- test results for all three trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read-across information, conducted following acceptable test guidelines for chronic aquatic toxicity with the following results for all three trophic levels:
- NOEC or EC10 greater than 1mg/L (for chemicals that are readily biodegradable).
Bioaccumulation potential
Bioaccumulation potential means that at least one of the following applies to the industrial chemical:
- it has a bioconcentration factor (BCF) greater than or equal to 500, or
- it has a bioaccumulation factor (BAF) greater than or equal to 500, or
- it has a partition coefficient (log Kow) greater than or equal to 4.0 (unless a measured BAF or BCF is <500).
Information required to demonstrate the absence of the hazard characteristic, bioaccumulation potential
The information required to demonstrate that a chemical does not have the hazard characteristic, bioaccumulation potential, is at least one of the following:
- information that demonstrates that the chemical is an inorganic chemical, or
- information that demonstrates that the chemical has a high molecular weight, or
- information that demonstrates that the chemical is a high molecular weight polymer with:
- less than 25% low molecular weight oligomeric species less than 1,000g/mol
- less than 10% low molecular weight oligomeric species less than 500g/mol, or
- information that demonstrates that the chemical has a solubility in water that is greater than 5g/L, measured following an acceptable test guideline for water solubility, or
- information that demonstrates that the chemical is a gas that is not expected to partition to the aquatic compartment, or
- a measured value from a study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for partition coefficient, for which log Kow less than 4.0, or
- a suitable in silico prediction for partition coefficient of the chemical using KOWWIN on the chemical for log Kow less than 4.0 (that is not negated by a measured log Kow), or
- a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioconcentration, for which the BCF less than 500, or
- a test result from an in vivo study on the chemical or from suitable read-across information, conducted following an acceptable test guideline for bioaccumulation, for which the BAF less than 500.