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 |
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9.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia) ►M70 — ◄ |
►M70
— 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 invertebrates 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 invertebrates (preferred species Daphnia), (Annex IX, point 9.1.5) 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 (solubility below 1 mg/L), or — for nanoforms with low dissolution rate in the relevant test media. |
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9.1.2. Growth inhibition study aquatic plants (algae preferred) |
►M70
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9.2. Degradation |
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9.2.1. Biotic |
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9.2.1.1. Ready biodegradability |
9.2.1.1. The study does not need to be conducted if the substance is inorganic. |
Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.