Decision tool – Hazard characteristics for environment exposure band 3

Question 2

This question relates to hazard band D. Does the definition of ozone-depleting apply to your chemical? You can 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? You can 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? You can 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? You can refer to Part 6.26.1 of the Categorisation Guidelines.

Question 7

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 medium to high.

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.

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Information demonstrating the chemical is a biological chemical.

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

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

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

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

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

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

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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

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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.

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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

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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

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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

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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

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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 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)
• chronic aquatic toxicity NOEC or EC10 greater than 0.01mg/L (for chemicals that are readily biodegradable)

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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.

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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.

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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 8

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

Question 9

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 medium to high.

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.

Information demonstrating the chemical has a molecular weight greater than 1000g/mol and has a low cationic density.

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Information demonstrating the chemical is a high molecular weight polymer with a low cationic density.

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Information demonstrating Entry 9 of Annex V of the REACH Regulation covers the chemical.

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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 with one of the following results for each of the three 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 0.1mg/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)

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

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

• in vivo studies for 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 chemicals that aren't readily biodegradable) or
• NOEC or EC10 greater than 0.01mg/L (for chemicals that are biodegradable)

Question 10

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

Question 11

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

Question 12

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 medium to high.

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.

Information demonstrating the chemical is inorganic.

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Information demonstrating the chemical is a biological chemical.

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

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

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

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

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

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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

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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.

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

A test result from a study either on 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

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

A test result from a study either on the chemical or from suitable read across information (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

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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

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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

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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.

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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 13

If you choose to stop here, your introduction will be considered to have a low indicative environment risk.

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 A and B characteristics.

Question 14

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

Question 15

This question relates to:

• Hazard band B
• 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 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 toxic to any aquatic life hazard characteristic in hazard band B.

Information that demonstrates the chemical has a molecular weight greater than 1,000g/mol and a low cationic density.

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Information that demonstrates the chemical is a high molecular weight polymer with a low cationic density.

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

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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 read across information, conducted following acceptable test guidelines for aquatic toxicity

The information should show:

• 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)

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

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

• in vivo studies for 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 1mg/L (for chemicals that are not readily biodegradable) or
• NOEC or EC10 greater than 0.1mg/L (for chemicals that are readily biodegradable).

Question 16

This question relates to hazard band A. Does your chemical contain aluminium, chromium, copper, nickel, selenium, silver or zinc?

Question 17

This question relates to hazard band A. Does the definition of a chemical that is harmful to aquatic life apply to your chemical? You can refer to 6.33.1 of the Categorisation Guidelines.

Question 18

This question relates to:

• Hazard band A
• Harmful to any aquatic life hazard characteristic in hazard band A

Do any of the following apply to your chemical? You can also refer to Part 6.33.2 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 harmful to aquatic life hazard characteristic in hazard band A.

Information that demonstrates the chemical has a molecular weight greater than 1,000g/mol and a low cationic density.

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Information that demonstrates the chemical is a high molecular weight polymer with a low cationic density.

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

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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:

• acute aquatic toxicity greater than 100 mg/L (LC50 (fish), or EC50 (invertebrates) or ErC50 (algae))
• chronic aquatic toxicity NOEC or EC10 greater than 1mg/L (for chemicals that are readily biodegradable)

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

Test results on 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 1mg/L (for chemicals that are readily biodegradable).

Question 19

This question relates to hazard band A. Does the definition of a chemical with bioaccumulation potential apply to your chemical? You can refer to 6.31.1 of the Categorisation Guidelines.

Question 20

This question relates to:

• Hazard band A
• Bioaccumulation potential hazard characteristic in hazard band A

Do any of the following apply to your chemical? You can also refer to Part 6.31.2 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 bioaccumulation potential hazard characteristic in hazard band A.

Information that demonstrates the chemical is an inorganic chemical.

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Information that demonstrates the chemical has a high molecular weight.

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Information that demonstrates 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

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Information that demonstrates the chemical has a solubility in water greater than 5g/L, measured following an acceptable test guideline for water solubility.

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Information that demonstrates the chemical is a gas that isn’t expected to partition to the aquatic compartment.

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A measured value from a study on the chemical or from suitable read-across information (both conducted following acceptable test guideline for partition coefficient) with log Kow less than 4.0.

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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).

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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) with BCF less than 500.

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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) with BAF less than 500.

Question 21

Does your chemical meet the definition of a polymer? You can refer to the definition in Part 1, Section 5 of the General Rules.

Your industrial chemical is a polymer if it meets both of the following criteria:

1. molecules are distributed over a range of molecular weights (where the difference in molecular weights is due to differences in the number of monomer units)
2. over 50% of the overall weight is made up of sequences of 3 or more monomer units and at least 1 more monomer unit or other reactant that can’t become a repeating unit in the polymer structure (this means over 50% of the substance must be polymer molecules)

Other definitions

Monomer

A chemical that is capable of forming covalent bonds with 2 or more like or unlike molecules under the conditions of a polymer-forming reaction used for a process of polymer formation.

Monomer unit

A reacted form of a monomer in a polymer.

Sequence

A continuous string of monomer units within the molecule that are covalently bonded to one another and are uninterrupted by units other than monomer units.

Polymer molecule

A molecule that contains a sequence of at least 3 monomer units, which are covalently bound to at least one other monomer unit or other reactant (i.e. ‘3+1’ rule).

Other reactant

A molecule that cannot become a repeating unit in the polymer structure.

Question 22

This question relates to hazard band A. Does the definition of a chemical that does not meet ready biodegradability criteria apply to your chemical? You can refer to 6.32.1 of the Categorisation Guidelines.

Question 22

This question relates to hazard band A. Does your chemical satisfy the definition for a polymer that does not have low cationic density? You can refer to the definition of a chemical that has a low cationic density in Section 5 of the General Rules.

Question 23

This question relates to:

• Hazard band A
• The chemical that does not meet the criteria for ready biodegradability hazard characteristic in Band A.

Do any of the following apply to your chemical? You can also refer to Part 6.32.2 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 hazard characteristic of a chemical that does not meet the criteria for ready biodegradability in hazard band A.

Information that demonstrates the chemical is highly volatile and it is expected to predominately partition to the air compartment.

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Information that demonstrates that it’s an inorganic chemical.

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Information that demonstrates that it’s a biological chemical.

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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 at least 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

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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 at least 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

Question 23

This question relates to hazard band A. Does the definition of a polymer that is not stable apply to your chemical? You can refer to 6.30.1 of the Categorisation Guidelines.

Question 24

This question relates to:

• Hazard band A
• The polymer that is not stable hazard characteristic in hazard band A.

Do any of the following apply to your chemical? You can also refer to Part 6.30.2 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 hazard characteristic, polymer that is not stable, in hazard band A.

Information that demonstrates that the polymer is protected from degradation by being encapsulated during use.

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Information that demonstrates all of the following applies to the polymer:

• it isn’t designed to be pyrolysed or burnt
• it isn’t designed or reasonably anticipated to substantially photodegrade
• it isn’t designed or reasonably anticipated to substantially biodegrade
• it isn’t explosive
• it’s hydrolytically stable (T½ greater than or equal to 12 hours)
• it isn’t a biological polymer
• it isn’t a polysaccharide
• measured data demonstrates that the polymer does not substantially biodegrade (if it’s a polymer with polyethylene glycol (PEG) functionalities and a solubility in water greater than 200 mg/L)
• measured data demonstrates that the polymer does not substantially biodegrade (if it’s a polymer with polypropylene glycol (PPG) functionalities and a solubility in water of greater than 200 mg/L)

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

• 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
• contains aluminium, chromium, copper, nickel, selenium, silver or zinc for environment hazard band A
• polymer that does not have a low cationic density hazard characteristic for environment hazard band A
• the polymer that is not stable hazard characteristic for environment hazard band A
• the bioaccumulation potential hazard characteristic for environment hazard band A
• chemical (other than a polymer) that does not meet the criteria for ready biodegradability hazard characteristic for environment hazard band A
• harmful to aquatic life hazard characteristic for environment hazard band A

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

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

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