9. ECOTOXICOLOGICAL INFORMATION
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COLUMN 1 STANDARD INFORMATION REQUIRED |
COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
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9.1. Aquatic toxicity |
9.1. Long-term aquatic toxicity testing referred to in Annex IX, subsection 9.1, in addition to short-term toxicity testing shall be proposed by the registrant or may be required by the Agency if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the effects on aquatic organisms, for example when further information is needed for the refinement of the PNEC or if additional toxicity information as set out in Annex XIII, point 3.2.3, would be necessary to assess PBT or vPvB properties of the substance. The choice of the appropriate test(s) shall be made on the basis of the results of the chemical safety assessment. |
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9.1.3. Short-term toxicity testing on fish |
9.1.3. The study does not need to be conducted in any of the following cases: — there are factors indicating that short-term 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, — a long-term aquatic toxicity study on fish is available. — For nanoforms, the study may not be waived on the basis of high insolubility in water alone. — The registrant may propose long-term toxicity testing instead of short-term toxicity testing. — Long-term toxicity testing on fish referred to in Annex IX, point 9.1.6, shall be proposed by the registrant or may be required by the Agency when it is unlikely that short-term toxicity testing can provide a true measure of the intrinsic aquatic toxicity of the substance, for instance: — if the substance is poorly water soluble (below 1 mg/L), or — for nanoforms with low dissolution rate in the relevant test media. |
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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. For nanoforms, the study may not be waived on the basis of high insolubility in water alone. 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. |
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9.2. Degradation |
►M70
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9.2.2. Abiotic 9.2.2.1. Hydrolysis as a function of pH. |
►M70
— the substance is readily biodegradable, — the substance is highly insoluble in water, — based on the structure, the substance does not have chemical groups that can hydrolyse. For nanoforms, the study may not be waived on the basis of high insolubility in water alone. ◄ |
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9.3. Fate and behaviour in the environment |
►M70
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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. The study may not be waived on the basis of low octanol-water partition coefficient alone, unless the adsorptive properties of the substance are solely driven by lipophilicity. For instance, the study may not be waived on the basis of low octanol-water partition coefficient alone if the substance is surface active or ionisable at environmental pH (pH 4 – 9). For nanoforms, use of any physicochemical property (e.g. octanol-water partition coefficient) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption. |