Optimized Strategies for Risk Assessment
of Industrial Chemicals through Integration
of Non-Test and Test Information

Specific Rules: The study does not need to be conducted if:
— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or

— a long-term aquatic toxicity study on invertebrates is available, or

— adequate information for environmental classification and labelling is available.

The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if the substance is poorly water soluble.

Specific Rule: The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.

Specific Rules: The study does not need to be conducted if:
— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or

— a long-term aquatic toxicity study on fish is available.

Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.
The long-term aquatic toxicity study on fish (Annex IX, Section 9.1.6) shall be considered if the substance is poorly water soluble.

Specific Rules: The study does not need to be conducted if:
— there is no emission to a sewage treatment plant, or

— there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or

— the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.

The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.

9.1.6.1. Fish early-life stage (FELS) toxicity test

9.1.6.2. Fish short-term toxicity test on embryo and sac-fry stages

9.1.6.3. Fish, juvenile growth test

Specific Rule: The study need not be conducted:
— if the substances is highly insoluble in water, or

— if the substance is readily biodegradable.

Specific Rule: The study need not be conducted:
— if the substance is readily biodegradable, or

— if direct and indirect exposure of soil is unlikely.

Specific Rule: The study need not be conducted:
— if the substance is readily biodegradable, or

— if direct and indirect exposure of sediment is unlikely.

9.2.2.1. Hydrolysis as a function of pH.

Specific Rules: The study does not need to be conducted if:
— the substance is readily biodegradable, or

— the substance is highly insoluble in water.

Specific Rule: Unless the substance is readily biodegradable.

Specific Rules: The study does not need to be conducted if:
— based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or

— the substance and its relevant degradation products decompose rapidly.

Specific Rules: The study need not be conducted if:
— the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes, or

— direct and indirect exposure of the aquatic compartment is unlikely.

Specific Rules: The study need not be conducted if:
— based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or

— the substance and its degradation products decompose rapidly.

Specific Rule: Further testing shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the chemical safety assessment according to Annex I indicates the need to investigate further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.

Specific Rule: Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

Specific Rule: Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.