[X1ANNEX VII U.K. STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE (1)

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9. ECOTOXICOLOGICAL INFORMATION U.K.

COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1
9.1. Aquatic toxicity
[F19.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia )

The registrant may consider long-term toxicity testing instead of short-term.

9.1.1. 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,

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

  • adequate information for environmental classification and labelling is available.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5.) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.]

[F19.1.2. Growth inhibition study aquatic plants (algae preferred)
9.1.2. 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.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.]

9.2. Degradation
9.2.1. Biotic
9.2.1.1. Ready biodegradability
9.2.1.1. The study does not need to be conducted if the substance is inorganic.]
(1)

[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]

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