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:
- 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)
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.