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Ecotoxicological information

Long-term toxicity to fish

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Description of key information

Waiving.

Key value for chemical safety assessment

Additional information

A long-term study on fish is waived according to principles described in section 3 of Annex XI of REACH.

In particular, section 3.1 says that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.

Criteria set out in paragraph (a) of section 3.2 apply to the test substance. In particular, it is stated that: (a) the manufacturer or importer demonstrates and documents that all of the following conditions are fulfilled:

(i) the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI section 3.5;

(ii) a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes;

(iii) the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposures are always well below the derived DNEL or PNEC.