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Decision tool – Hazard characteristics for human health exposure band 3

This decision tool is related to step 4.4 and 4.5 of the process to categorise your chemical introduction.

Optional: If you’d like to save or print your completed decision tool for your own records, click on ‘Chemical identity’ before Question 1 and enter your chemical’s name or CAS number. Note that a copy of a completed decision tool is not sufficient to meet your record-keeping obligations. To save as a PDF, select the print option in your browser and choose ‘Save as PDF’ or ‘Microsoft Print to PDF’. For Safari users, click 'File' and 'Export to PDF'.

Who should use this?

This decision tool only applies for introductions with a human health exposure band of 3. If your introduction is in human health exposure band 3, you can use this decision tool to help you work out:

  • if your chemical has certain human health hazard characteristics
  • your introduction's indicative human health risk

If you're working out if your introduction's indicative human health risk is low, you'll have to answer 1-7 questions depending on your circumstances.

If you're working out if your introduction's indicative human health risk is very low, you'll have to answer 1-34 questions depending on your circumstances.

This tool refers to the Industrial Chemicals Categorisation Guidelines. You can find this document on this page:

See the full list of decision tools to help you categorise your introduction

Help us improve these tools by giving us your feedback.

Information about the following for your chemical:

  • if it is an inorganic arsenic compound  
  • if it contains beryllium, cadmium, chromium (VI), lead or nickel  
  • carcinogenicity 
  • reproductive toxicity
  • developmental toxicity
  • adverse effects mediated by an endocrine mode of action 
  • genetic toxicity 
  • high molecular weight polymer that is water absorbing
  • respiratory sensitisation 
  • corrosive to the respiratory tract
  • specific target organ toxicity after a single exposure (significant toxicity)
  • skin corrosion
  • eye damage
  • skin sensitisation
  • acute toxicity (fatal or toxic)
  • specific target organ toxicity after repeated exposure
  • 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 toxicity (harmful)
  • is it on the list of chemicals with high hazards for categorisation.

What is your chemical's name or CAS number? (optional)

Note: enter this information if you'd like to save a copy for your own records by using the print function in your browser. A completed decision tool is not sufficient to meet your record-keeping obligations. 

Enter the CAS number or chemical name

Question 1

Do any of the following scenarios apply to your chemical?

Scenario 1: your chemical on the list of chemicals with high hazards for categorisation based on one or more of the following hazard characteristics? If your chemical's an ester or salt, there are extra requirements when you check the list.

  • Carcinogenicity
  • Reproductive toxicity
  • Developmental toxicity
  • Adverse effects mediated by an endocrine mode of action
  • Genetic toxicity

Scenario 2: your chemical is an inorganic arsenic compound

Scenario 3: your chemical contains beryllium, cadmium, chromium (VI), lead or nickel

Question 2

Does the definition of carcinogenicity apply to your chemical (refer to Part 6.3.1 of the Categorisation Guidelines)?

Question 3

Does the definition of reproductive toxicity apply to your chemical (refer to Part 6.4.1 of the Categorisation Guidelines)?

Question 4

Does the definition of developmental toxicity apply to your chemical (refer to Part 6.5.1 of the Categorisation Guidelines)?

Question 5

Does the definition of adverse effects mediated by an endocrine mode of action apply to your chemical (refer to Part 6.6.1 of the Categorisation Guidelines)?

Question 6

Does the definition of genetic toxicity apply to your chemical (refer to Part 6.7.1 of the Categorisation Guidelines)?

Question 7

Do you want to find out if your introduction could have a very low indicative human health risk?

Question 8

This question relates to the genetic toxicity hazard characteristic in hazard band C. Does at least one of the following apply to your chemical? You can also refer to Part 6.7.2 of the Categorisation Guidelines. 

Note: You can choose not to check the list. If you do, your introduction’s indicative human health risk will be low.

Note: If you check the list and can answer ‘yes’, you will have shown that your chemical doesn’t have the genetic toxicity hazard characteristic in hazard band C.

The chemical's included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

The chemical has been notified to the US FDA GRAS notification program and the FDA had no questions about the notifier’s conclusion of GRAS status and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation.

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.

Information demonstrating 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
  • test results from a study on the chemical or from suitable read across information conducted following an acceptable test guideline for chromosomal abnormalities

Question 9

This question relates to hazard band B. Does the definition of ‘high molecular weight polymer that is water absorbing’ apply to your chemical (refer to Part 6.8.1 of the Categorisation Guidelines)?

Question 9

This question relates to the genetic toxicity hazard characteristic in hazard band C. Did you answer no because you didn’t have any information relevant to the list in the last question?

Question 10

This question relates to the ‘high molecular weight polymer that is water absorbing’ hazard characteristic in hazard band B. Do any of the following apply to your chemical? You can also refer to Part 6.8.2 of the Categorisation Guidelines. 

Note: You can choose not to check the list. If you do, your introduction’s indicative human health risk will be low.

Note: If you check the list and can answer ‘yes’, you will have shown that your chemical doesn’t have the ‘high molecular weight polymer that is water absorbing’ hazard characteristic in hazard band B.

The chemical is not a polymer.

Molecular weight information for the polymer that demonstrates the number average molecular weight (NAMW) is less than 10,000 g/mol.

Information that demonstrates that the polymer is not introduced in a particulate form.

Particle size information for the polymer that demonstrates that the particle size is greater than or equal to 10 micrometres (microns).

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.

Question 11

This question relates to hazard band B. Does the definition of respiratory sensitisation apply to your chemical (refer to Part 6.9.1 of the Categorisation Guidelines)?

Question 12

This question refers to hazard band B. Does the definition of ‘corrosive to the respiratory tract’ apply to your chemical (refer to Part 6.10.1 of the Categorisation Guidelines)?

Question 13

This question refers to hazard band B. Does the definition of ‘specific target organ toxicity after a single exposure (significant toxicity)’ apply to your chemical (refer to Part 6.11.1 of the Categorisation Guidelines)?

Question 14

This question refers to hazard band B. Does the definition of ‘skin corrosion’ apply to your chemical (refer to Part 6.12.1 of the Categorisation Guidelines)?

Question 15

This question refers to the ‘skin corrosion’ hazard characteristic in hazard band B. Does at least one of the following apply to your chemical? You can also refer to Part 6.12.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘skin corrosion’ hazard characteristic in hazard band B.

Information that demonstrates that the chemical is a high molecular weight polymer that doesn't contain any of the following reactive functional groups:

  • anhydride
  • epoxide
  • sulfonic acid
  • amine

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
  • epoxide
  • sulfonic acid
  • amine

A suitable in silico prediction indicating that the chemical is not irritating to skin or has no alerting groups for skin irritation.

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.

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.

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 (category 1) in chapter 3.2 of the GHS.

Question 16

This question refers to hazard band B. Does the definition of ‘eye damage’ apply to your chemical (refer to Part 6.13.1 of the Categorisation Guidelines)?

Question 17

This question refers to the ‘eye damage’ hazard characteristic in hazard band B. Does at least one of the following apply to your chemical? You can also refer to Part 6.13.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘eye damage’ hazard characteristic in hazard band B.

Information demonstrating the chemical is a high molecular weight polymer that doesn't contain any of the following reactive functional groups:

  • anhydride
  • epoxide
  • sulfonic acid
  • amine

Information demonstrating 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
  • epoxide
  • sulfonic acid
  • amine

A suitable in silico prediction indicating that the chemical isn't irritating to the eye.

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 wouldn't 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 doesn't result in effects on the eye, as described for eye damage (Category 1) in chapter 3.3 of the GHS.

Question 18

This question refers to hazard band B. Does the definition of ‘skin sensitisation’ apply to your chemical (refer to Part 6.14.1 of the Categorisation Guidelines)?

Question 19

This question refers to the ‘skin sensitisation’ hazard characteristic in hazard band B. Does at least one of the following apply to your chemical? You can also refer to Part 6.14.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘skin sensitisation’ hazard characteristic in hazard band B.

The chemical is corrosive to the skin (GHS category 1).

Information that demonstrates the chemical is a high molecular weight polymer for which at least one of the following applies:

  • it contains only low concern reactive functional groups
  • it contains only low concern reactive functional groups and unsubstituted positions ortho and para to phenolic hydroxyl groups
  • the only reactive functional groups it contains are unsubstituted positions ortho and para to phenolic hydroxyl groups, or
  • it contains only low and moderate concern reactive functional groups, with a combined functional group equivalent weight for the moderate-concern functional groups of greater than or equal to 1000 g/mol
  • it contains only moderate concern reactive functional groups, with a combined functional group equivalent weight of greater than or equal to 1000 g/mol
  • it 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
    • less than 5% by mass of molecules with molecular weight that is less than 1,000 g/mol

Information that demonstrates the chemical is a substance covered by Entry 9 of Annex V, of the REACH Regulation.

Results from a defined approach (combination of tests) described in OECD TG 497, with a non-sensitising prediction*

*Note that negative results only with key event 1 and key event 2 adverse outcome pathway (AOP) assays will not rule out skin sensitisation potential for some weak skin sensitisers and pre-/pro-hapten fragrance chemicals when using the "2 out of 3" (2o3) defined approach and hence this should be considered when determining an appropriate testing methodology. For further information see: ENV/CBC/MONO(2021)11. Supporting Document to the OECD Guideline 497 on Defined Approaches for Skin Sensitisation

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 the adverse outcome pathway for skin sensitisation, with a non-sensitising prediction
  • 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 the adverse outcome pathway for skin sensitisation, with a non-sensitising prediction
  • 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 the adverse outcome pathway for 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 doesn't result in induction of an allergic response, as described in chapter 3.4 of the GHS.

Question 20

This question refers to hazard band B. Does the definition of ‘acute toxicity (fatal or toxic)’ apply to your chemical (refer to Part 6.15.1 of the Categorisation Guidelines)?

Question 21

This question refers to the ‘acute toxicity (fatal or toxic)’ hazard characteristic in hazard band B. Do any of the following apply to your chemical? You can also refer to part 6.15.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘acute toxicity (fatal or toxic)’ hazard characteristic in hazard band B.

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) or base (pH greater than or equal to 11.5), and has high high buffering capacity (if relevant).

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
  • 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

Information that demonstrates 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

The chemical's included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

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 the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

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, and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information that demonstrates the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation.

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
  • conducted following an acceptable test guideline for acute dermal toxicity with an LD50 greater than1,000 mg/kg bw
  • 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

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.

Question 22

This question refers to hazard band B. Does the definition of ‘specific target organ toxicity after repeated exposure’ apply to your chemical (refer to Part 6.16.1 of the Categorisation Guidelines)?

Question 23

This question refers to hazard band A. Does the definition of ‘high molecular weight polymer that has lung overloading potential’ apply to your chemical (refer to Part 6.17.1 of the Categorisation Guidelines)? 

Question 24

This question relates to the ‘high molecular weight polymer that has lung overloading potential’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? You can also refer to Part 6.17.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘high molecular weight polymer that has lung overloading potential’ hazard characteristic in hazard band A.

The chemical is not a polymer. 

Molecular weight information for the polymer that demonstrates that the number average molecular weight (NAMW) is less than or equal to 70,000 g/mol.

Information that shows 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 (OECD test guidelines 105, an equivalent, or 120).

Information that shows the polymer doesn't become aerosolised during end use.

Question 25

This question refers to hazard band A. Does the definition of ‘aspiration hazard’ apply to your chemical (refer to Part 6.18.1 of the Categorisation Guidelines)? 

Question 26

This question refers to hazard band A. Is the chemical a hydrocarbon?

Question 27

This question refers to hazard band A. Does the definition of ‘specific target organ toxicity after a single exposure (harmful or transient effects)’ apply to your chemical (refer to Part 6.19.1 of the Categorisation Guidelines)?  

Question 28

This question refers to hazard band A. Does the definition of ‘skin irritation’ apply to your chemical (refer to Part 6.20.1 of the Categorisation Guidelines)?

Question 29

This question refers to the ‘skin irritation’ hazard characteristic in hazard band A. Do any of the following apply to your chemical?

You can refer to Part 6.20.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘skin irritation’ hazard characteristic in hazard band A.

A suitable in silico prediction indicating that the chemical is not irritating to the skin.

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.

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 (Category 2) in chapter 3.2 of the GHS.

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.

Question 30

This question refers to hazard band A. Does the definition of ‘eye irritation’ apply to your chemical (refer to Part 6.21.1 of the Categorisation Guidelines)?

Question 31

This question refers to the ‘eye irritation’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? 

You an also refer to Part 6.21.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘eye irritation’ hazard characteristic in hazard band A.

A suitable in silico prediction indicating that the chemical is not irritating to the eyes.

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.

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.

Question 32

This question refers to hazard band A. Does the definition of ‘acute toxicity (harmful)’ apply to your chemical (refer to Part 6.22.1 of the Categorisation Guidelines)? 

Question 33

This question refers to the ‘acute toxicity (harmful)’ hazard characteristic in hazard band A. Does at least one of the following apply to your chemical?

You can also refer to Part 6.22.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘acute toxicity (harmful)’ hazard characteristic in hazard band A.

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
  • 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

Information that demonstrates 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 

The chemical's included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

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 the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

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, and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation.

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
  • conducted following an acceptable test guideline for acute dermal toxicity with an LD50  greater than 2,000 mg/kg bw
  • 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

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.

Question 27

Do you have test results that measured the kinematic viscosity of the chemical to be greater than 20.5mm2/s at 40 degrees celsius?

Question 28

This question refers to hazard band A. Does the definition of ‘specific target organ toxicity after a single exposure (harmful or transient effects)’ apply to your chemical?

You can also refer to Part 6.19.1 of the Categorisation Guidelines.

Question 29

This question refers to hazard band A. Does the definition of ‘skin irritation’ apply to your chemical?

You can also refer to Part 6.20.1 of the Categorisation Guidelines.

Question 30

This question refers to the ‘skin irritation’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? 

You can also refer to Part 6.20.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘skin irritation’ hazard characteristic in hazard band A.

A suitable in silico prediction indicating that the chemical is not irritating to the skin.

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.

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 (Category 2) in chapter 3.2 of the GHS.

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.

Question 31

This question refers to hazard band A. Does the definition of ‘eye irritation’ apply to your chemical?

You can also refer to Part 6.21.1 of the Categorisation Guidelines.

Question 32

This question refers to the ‘eye irritation’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? 

You can also refer to Part 6.21.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘eye irritation’ hazard characteristic in hazard band A.

A suitable in silico prediction indicating that the chemical is not irritating to the eyes.

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.

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.

Question 33

This question refers to hazard band A. Does the definition of ‘acute toxicity (harmful)’ apply to your chemical?

You can also refer to Part 6.22.1 of the Categorisation Guidelines.

Question 34

This question refers to the ‘acute toxicity (harmful)’ hazard characteristic in hazard band A. Do any of the following apply to your chemical? 

You can also refer to Part 6.22.2 of the Categorisation Guidelines.

Note: You can choose not to check the list. If you do, your introduction's indicative human health risk will be low.

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the ‘acute toxicity (harmful)’ hazard characteristic in hazard band A.

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
  • 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

Information that demonstrates 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 

The chemical's included in the Select Committee on GRAS Substances (SCOGS) Database as a Type 1 conclusion, and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

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 the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

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, and the human health exposure expected from the industrial use of the chemical is no higher than the human health exposure expected from food use.

Information that demonstrates that the chemical is a substance covered by Entry 9 of Annex V of the REACH Regulation.

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
  • conducted following an acceptable test guideline for acute dermal toxicity with an LD50  greater than 2,000 mg/kg bw
  • 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

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.

Your introduction’s indicative human health risk is very low.

Go to Decision tool – Work out your environment exposure band.

Your introduction's indicative human health risk is low. Make a note of this outcome.

Go to Decision tool – Work out your environment exposure band.

Your introduction's indicative human health risk is medium to high and is in the assessed category. This means that you must apply for an assessment certificate before you can introduce your chemical. To work out which type of certificate you need to apply for, you must continue and work out your introduction's indicative risk to the environment.

Go to Decision tool – Work out your environment exposure band.

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