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Long-term toxicity to fish

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Link to relevant study record(s)

fish early-life stage toxicity
Data waiving:
other justification
Justification for data waiving:

Description of key information

Waiving in accordance with column 2 of REACH Annex IX

Key value for chemical safety assessment

Additional information

A long-term study according to OECD TG 204 is available (Ch. 6.1.1: Hoechst AG, 1991). However, the results of this study cannot be used to assess long-term toxicity according to the REACH Guidance document. Only studies performed with sensitive life-stages (juveniles, fertilised eggs, larvae) are considered suitable for this endpoint.

In accordance with column 2 of REACH Annex IX, long-term testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. CSA resulted in RCRs below 1 for all environmental compartments, thus demonstrating safe use. Furthermore, the substance is not classified as dangerous to the environment according to Regulation (EC) No 1272/2008 or assessed as PBT / vPvB. Therefore and for reasons of animal welfare a long-term toxicity study with fish is not proposed.