Decision tool – Hazard characteristics for environment exposure band 2

Question 2

This question relates to hazard band D. Does the definition of ozone‐depleting apply to your chemical (refer to Part 6.23.1 of the Categorisation Guidelines)?

Question 3

This question relates to hazard band D. Does the definition of synthetic greenhouse gas apply to your chemical (refer to Part 6.24.1 of the Categorisation Guidelines)?

Question 4

This question relates to hazard band D. Is your chemical on the list of chemicals with high hazards for categorisation for any of the following hazard characteristics? If your chemical's an ester or salt, there are extra requirements when checking the list for the hazard characteristic, adverse effects mediated by an endocrine mode of action.

• Adverse effects mediated by an endocrine mode of action
• Persistent, bioaccumulative and toxic

Question 5

This question relates to hazard band D. Does the definition of adverse effects mediated by an endocrine mode of action apply to your chemical (refer to Part 6.25.1 of the Categorisation Guidelines)?

Question 6

This question relates to hazard band D. Does the hazard band D definition of persistent, bioaccumulative and toxic apply to your chemical (refer to Part 6.26.1 of the Categorisation Guidelines)?

Question 7

Do you want to find out if your introduction could have a very low indicative environment risk?If you do, you'll have to answer questions about:

• hazard band B and C characteristics
• the persistent, bioaccumulative and toxic hazard characteristic for your chemical.

Question 8

This question relates to:

• hazard band D
• the persistent, bioaccumulative and toxic hazard characteristic in hazard band D

Do any of the following apply to your chemical? You can also refer to Part 6.26.2 of the Categorisation Guidelines.

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

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the persistent, bioaccumulative and toxic hazard characteristic in hazard band D.

Information demonstrating the chemical is inorganic.

---

Information demonstrating the chemical is a biological chemical.

---

Information demonstrating the chemical has a molecular weight that is greater than 1000 g/mol.

---

Information demonstrating the chemical is a high molecular weight polymer with: 

• less than 25% low molecular weight oligomeric species < 1000g/mol and
• less than 10% low molecular weight oligomeric species less than 500g/mol

---

Information demonstrating the chemical has a solubility in water that is greater than 5g/L (measured using an acceptable test guideline for water solubility).

---

Information demonstrating the chemical is a gas that is not expected to partition to the aquatic compartment

---

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

---

A suitable in silico prediction for partition coefficient of the chemical:

• of log Kow less than 4.2 and
• not negated by a measured log Kow

---

A measured value from a study on the chemical or from suitable read-across information (both conducted following an acceptable test guideline for partition coefficient) with log Kow less than 4.2.

---

Note: The following applies if the chemical is not a highly branched organic chemical.

A test result from a study on either the chemical or from suitable read across information (conducted following an acceptable test guideline for ready biodegradability) meeting 1 or more of the following degradation pass levels during the test method's specified period: 

• 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

---

Note: The following applies 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 (both conducted following an acceptable test guideline for transformation in aquatic sediment systems) resulting 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

---

Note: The following applies if the chemical is a highly branched organic chemical.

A test result from a study on the chemical (conducted following an acceptable test guideline for ready biodegradability) meeting 1 or more of the following degradation pass levels during the test method's specified period: 

• 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

---

Note: The following applies if the chemical is a highly branched organic chemical.

A test result from a study on the chemical (conducted following an acceptable test guideline for transformation in aquatic sediment systems) resulting 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

---

Note: The following applies 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 for the chemical or
• in vivo studies for either the chemical or on suitable read across information, conducted following acceptable test guidelines for aquatic toxicity

The information should show at least one of the following results for each of the 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)
• chronic aquatic toxicity NOEC or EC10 greater than 0.01mg/L (for chemicals that are readily biodegradable)

---

Note: The following applies if the chemical is a biocidal active or a persistent, highly branched organic chemical.

Test results on chronic aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae) from:

• in vivo studies on either the chemical or on suitable read across information, conducted following acceptable test guidelines for chronic aquatic toxicity

The test results should show:

• NOEC or EC10 greater than 0.1mg/L for all 3 trophic levels.

---

A test result from an in vivo study on the chemical or from suitable read-across information (both conducted following an acceptable test guideline for bioconcentration) showing BCF less than 2,000.

---

A test result from an in vivo study on the chemical or from suitable read-across information (both conducted following an acceptable test guideline for bioaccumulation) showing BAF less than 2,000.

Question 9

This question relates to hazard band C. Does the definition of very toxic to any aquatic life apply to your chemical (refer to Part 6.27.1 of the Categorisation Guidelines)?

Question 10

This question relates to:

• hazard band C
• the very toxic to any aquatic life hazard characteristic in hazard band C

Do any of the following apply to your chemical? You can also refer to Part 6.27.2 of the Categorisation Guidelines.

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

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the very toxic to any aquatic life hazard characteristic in hazard band C.

Do any of the following apply?

Any of the following:

• information showing the chemical has a molecular weight greater than 1000g/mol and has a low cationic density
• information showing the chemical is a high molecular weight polymer with a low cationic density
• information showing Entry 9 of Annex V of the REACH Regulation covers the chemical
• information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae) from suitable in silico predictions, in vivo studies or read across information (all 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 NOEC]
  • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that aren't readily biodegradable) or
  • chronic aquatic toxicity NOEC or EC10 greater than 0.01mg/L (for chemicals that are readily biodegradable)

If the chemical is a biocidal active or a persistent, highly branched organic chemical:

• test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read across information (both conducted following acceptable test guidelines for chronic aquatic toxicity) with the following results for all 3 trophic levels:
  • NOEC or EC10 greater than 0.1mg/L (for chemicals that aren't readily biodegradable)
  • NOEC or EC10 greater than 0.01mg/L (for chemicals that are biodegradable)

Question 11

This question relates to hazard band C. Is your chemical on the list of chemicals with high hazards for categorisation for being persistent and bioaccumulative?

Question 12

This question relates to hazard band C. Does the definition of persistent and bioaccumulative apply to your chemical (refer to Part 6.28.1 of the Categorisation Guidelines)?

Question 13

This question relates to:

• hazard band C
• the persistent and bioaccumulative hazard characteristic in hazard band C

Do any of the following apply to your chemical? You can also refer to Part 6.28.2 of the Categorisation Guidelines.

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

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

Do any of the following apply?

Information showing the chemical:

• is inorganic
• is biological
• has a molecular weight that is greater than 1000 g/mol
• is a high molecular weight polymer
• has a solubility in water that is greater than 5g/L (measured using an acceptable test guideline for water solubility) or
• is a gas that is not expected to partition to the aquatic compartment

A suitable in silico prediction for partition coefficient of the chemical:

• of log Kow less than 4.2 and
• not negated by a measured log Kow

A measured value from a study on the chemical or from suitable read‐across information (both conducted following an acceptable test guideline for partition coefficient) with log Kow less than 4.2.

If the chemical's not a highly branched organic chemical:

• a test result from a study on the chemical or from suitable read across information (both conducted following an acceptable test guideline for ready biodegradability) meeting 1 or more of the following degradation pass levels during the test method's specified period:
  • tests based on dissolved organic carbon (DOC) – greater than or equal to 70% DOC removal
  • 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
• a test result from a study on the chemical or from suitable read across information (both conducted following an acceptable test guideline for transformation in aquatic sediment systems) resulting 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

If the chemical's a highly branched organic chemical:

• a test result from a study on the chemical (conducted following an acceptable test guideline for ready biodegradability) meeting 1 or more of the following degradation pass levels during the test method's specified period:
  • tests based on dissolved organic carbon (DOC) – greater than or equal to 70% DOC removal
  • 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
• a test result from a study on the chemical (conducted following an acceptable test guideline for transformation in aquatic sediment systems) resulting 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

A test result from an in vivo study on the chemical or from suitable read‐across information (both conducted following an acceptable test guideline for bioconcentration) showing BCF less than 2000.

A test result from an in vivo study on the chemical or from suitable read‐across information (both conducted following an acceptable test guideline for bioaccumulation) showing BAF less than 2000.

Question 14

This question relates to hazard band B. Does the definition of toxic to any aquatic life apply to your chemical (refer to Part 6.29.1 of the Categorisation Guidelines)?

Question 15

This question relates to the toxic to any aquatic life hazard characteristic in hazard band B.

Do any of the following apply to your chemical? You can also refer to Part 6.29.2 the Categorisation Guidelines.

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

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the toxic to any aquatic life hazard characteristic in hazard band B.

Do any of the following apply?

Information showing the chemical:

• has a molecular weight greater than 1000g/mol and has a low cationic density
• is a high molecular weight polymer with a low cationic density
• is covered by Entry 9 of Annex V of the REACH Regulation

If the chemical's not a biocidal active and not a persistent, highly branched chemical:

• information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae) from suitable in silico predictions, in vivo studies or read across information (all conducted following acceptable test guidelines for aquatic toxicity) with the following results for all 3 trophic levels:
  • acute aquatic toxicity greater than 10 mg/L [LC50 (fish), or EC50 (invertebrates) or ErC50 (algae), or NOEC]
  • chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that aren't readily biodegradable)
  • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are biodegradable)

If the chemical's a biocidal active or a persistent, highly branched organic chemical:

• information on chronic aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae) from suitable in vivo studies or read across information (all conducted following acceptable test guidelines for chronic aquatic toxicity) with the following results:
  • chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that aren't readily biodegradable) or
  • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable)

Question 9

This question relates to the persistent, bioaccumulative and toxic hazard characteristic in hazard band D. Did you answer 'no' because you didn't have any information relevant to the list in Question 8?

Question 10

Based on the information you used to answer Question 8, does the hazard band D definition of persistent, bioaccumulative and toxic apply to your chemical (refer to Part 6.26.1 of the Categorisation Guidelines)?

Question 11

This question relates to hazard band C. Does the definition of very toxic to any aquatic life apply to your chemical (refer to Part 6.27.1 of the Categorisation Guidelines)?

Question 12

This question relates to:

• hazard band C
• the very toxic to any aquatic life hazard characteristic in hazard band C

Do any of the following apply to your chemical? You can also refer to Part 6.27.2 of the Categorisation Guidelines.

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

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the very toxic to any aquatic life hazard characteristic in hazard band C.

Do any of the following apply?

Any of the following:

• information showing the chemical has a molecular weight greater than 1000g/mol and has a low cationic density
• information showing the chemical is a high molecular weight polymer with a low cationic density
• information showing Entry 9 of Annex V of the REACH Regulation covers the chemical
• information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae) from suitable in silico predictions, in vivo studies or read across information (all 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 NOEC]
  • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that aren't readily biodegradable) or
  • chronic aquatic toxicity NOEC or EC10 greater than 0.01mg/L (for chemicals that are readily biodegradable)

If the chemical is a biocidal active or a persistent, highly branched organic chemical:

• test results for all 3 trophic levels (fish, invertebrates and algae) from in vivo studies on the chemical or from suitable read across information (both conducted following acceptable test guidelines for chronic aquatic toxicity) with the following results for all 3 trophic levels:
  • NOEC or EC10 greater than 0.1mg/L (for chemicals that aren't readily biodegradable)
  • NOEC or EC10 greater than 0.01mg/L (for chemicals that are biodegradable)

Question 13

This question relates to hazard band C. Is your chemical on the list of chemicals with high hazards for categorisation for being persistent and bioaccumulative?

Question 14

This question relates to hazard band C. Does the definition of persistent and bioaccumulative apply to your chemical (refer to Part 6.28.1 of the Categorisation Guidelines)?

Question 15

This question relates to:

• hazard band C
• the persistent and bioaccumulative hazard characteristic in hazard band C

Do any of the following apply to your chemical? You can also refer to Part 6.28.2 of the Categorisation Guidelines.

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

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the persistent and bioaccumulative hazard characteristic in hazard band C.

Do any of the following apply?

Information showing the chemical:

• is inorganic
• is biological
• has a molecular weight that is greater than 1000 g/mol
• is a high molecular weight polymer
• has a solubility in water that is greater than 5g/L (measured using an acceptable test guideline for water solubility) or
• is a gas that is not expected to partition to the aquatic compartment

A suitable in silico prediction for partition coefficient of the chemical:

• of log Kow less than 4.2 and
• not negated by a measured log Kow

A measured value from a study on the chemical or from suitable read‐across information (both conducted following an acceptable test guideline for partition coefficient) with log Kow less than 4.2.

If the chemical's not a highly branched organic chemical:

• a test result from a study on the chemical or from suitable read across information (both conducted following an acceptable test guideline for ready biodegradability) meeting 1 or more of the following degradation pass levels during the test method's specified period:
  • tests based on dissolved organic carbon (DOC) – greater than or equal to 70% DOC removal
  • 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
• a test result from a study on the chemical or from suitable read across information (both conducted following an acceptable test guideline for transformation in aquatic sediment systems) resulting 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

If the chemical's a highly branched organic chemical:

• a test result from a study on the chemical (conducted following an acceptable test guideline for ready biodegradability) meeting 1 or more of the following degradation pass levels during the test method's specified period:
  • tests based on dissolved organic carbon (DOC) – greater than or equal to 70% DOC removal
  • 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
• a test result from a study on the chemical (conducted following an acceptable test guideline for transformation in aquatic sediment systems) resulting 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

A test result from an in vivo study on the chemical or from suitable read‐across information (both conducted following an acceptable test guideline for bioconcentration) showing BCF less than 2000.

A test result from an in vivo study on the chemical or from suitable read‐across information (both conducted following an acceptable test guideline for bioaccumulation) showing BAF less than 2000.

Question 16

This question relates to hazard band B. Does the definition of toxic to any aquatic life apply to your chemical (refer to Part 6.29.1 of the Categorisation Guidelines)?

Question 17

This question relates to the toxic to any aquatic life hazard characteristic in hazard band B.

Do any of the following apply to your chemical? You can also refer to Part 6.29.1 the Categorisation Guidelines.

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

Note: If you check the list and can answer 'Yes', you will have shown your chemical doesn't have the toxic to any aquatic life hazard characteristic in hazard band B.

Do any of the following apply?

Information showing the chemical:

• has a molecular weight greater than 1000g/mol and has a low cationic density
• is a high molecular weight polymer with a low cationic density
• is covered by Entry 9 of Annex V of the REACH Regulation

If the chemical's not a biocidal active and not a persistent, highly branched chemical:

• information on aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae) from suitable in silico predictions, in vivo studies or read across information (all conducted following acceptable test guidelines for aquatic toxicity) with the following results for all 3 trophic levels:
  • acute aquatic toxicity greater than 10 mg/L [LC50 (fish), or EC50 (invertebrates) or ErC50 (algae), or NOEC]
  • chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that aren't readily biodegradable)
  • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are biodegradable)

If the chemical's a biocidal active or a persistent, highly branched organic chemical:

• information on chronic aquatic toxicity for all 3 trophic levels (fish, invertebrates and algae) from suitable in vivo studies or read across information (all conducted following acceptable test guidelines for chronic aquatic toxicity) with the following results:
  • chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that aren't readily biodegradable) or
  • chronic aquatic toxicity NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable)

Your introduction's indicative environment risk is medium to high. Make a note of this outcome.

Go to Decision tool – Work out your introduction category.

You’ve shown your chemical is very toxic to any aquatic life.

Your introduction’s indicative environment risk is low.

Make a note of this outcome. Go to Decision tool – Work out your introduction category.

You’ve shown your chemical is persistent and bioaccumulative.

Your introduction’s indicative environment risk is low. Make a note of this outcome.

Go to Decision tool – Work out your introduction category.

You've shown your chemical is toxic to any aquatic life.

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

Go to Decision tool – Work out your introduction category.

You've shown your chemical doesn't have the:

• contains arsenic, cadmium, lead or mercury hazard characteristic for environment hazard band D
• ozone depleting hazard characteristic for environment hazard band D
• synthetic greenhouse gas hazard characteristic for environment hazard band D
• adverse effects mediated by an endocrine mode of action hazard characteristic for environment hazard band D
• persistent, bioaccumulative and toxic hazard characteristic for environment hazard band D
• very toxic to any aquatic life hazard characteristic for environment hazard band C
• persistent and bioaccumulative hazard characteristic for environment hazard band C
• toxic to aquatic life hazard characteristic for environment hazard band B

Your introduction's indicative environment risk is very low. Make a note of this outcome.

Go to Decision tool – Work out your introduction category.

Your introduction’s indicative environment risk is low. Make a note of this outcome.

Go to Decision tool – Work out your introduction category.