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9.: ECOTOXICOLOGICAL INFORMATION


COLUMN 1

STANDARD INFORMATION REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1.3.  Short-term toxicity testing on fish: the registrant may consider long-term toxicity testing instead of short-term.

9.1.3.  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.

9.1.4.  Activated sludge respiration inhibition testing

9.1.4.  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.

9.2.  Degradation

9.2.  Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.

9.2.2.  Abiotic

9.2.2.1.  Hydrolysis as a function of pH.

9.2.2.1.  The study does not need to be conducted if:

— the substance is readily biodegradable, or

— the substance is highly insoluble in water.

9.3.  Fate and behaviour in the environment

9.3.1.  Adsorption/desorption screening

9.3.1.  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.