Registration Dossier
Registration Dossier
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EC number: 911-811-2 | CAS number: -
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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 short-term data available for three trophic levels, and long-term data for two trophic levels. No effects were observed in fish below 100 mg/l, indicating low toxicity. An assessment factor of 50 was applied to derive the freshwater PNEC using the long-term algal result. The availability of two long-term test results including 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 long-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.
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