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Ecotoxicological information

Long-term toxicity to fish

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Administrative data

Link to relevant study record(s)

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

Description of key information

Key value for chemical safety assessment

Additional information

Testing for long-term toxicity to fish is not considered necessary because:  In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that further testing is not justified for the following reasons: The substance has acute data available for three trophic levels, chronic algal toxicity data, and a chronic invertebrates study has been commissioned. No effects were observed in fish below 100 mg/l, indicating low toxicity.  An assessment factor of 1000 was applied to derive the freshwater PNEC using the short-term algal result. The availability of the long-term result covering the most sensitive species (algae) in the aquatic tests, and the application of an appropriate assessment factor, means it is, therefore, unlikely that the aquatic PNEC would be significantly over-estimated. A PNEC has been derived for the purpose of chemical safety assessment and the risk characterisation ratios are below 1.   The substance is highly water-soluble, has low bioavailability based on log Kow  <3 (-4).   Overall, it is concluded that the risk is adequately assessed using the short-term data, and that in vivo testing on vertebrate animals is not considered necessary or justified on ethical grounds.   Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 Ecotoxicological Information and Chapters 9 and 10 of the Chemical Safety Report, respectively.