Registration Dossier
Registration Dossier
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EC number: 940-877-5 | CAS number: -
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to further investigate the effects on fish.
Key value for chemical safety assessment
Additional information
There are no long-term toxicity studies to fish available for Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid. However, short-term toxicity studies are available for all three trophic levels, fish, daphnia and algae, and no effects were observed up to the highest test concentration of 100 mg/L. According to the “Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance”, if invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish (ECHA, 2017). Therefore, in this case, a long-term toxicity study was conducted with Daphnia magna. As the NOEC values obtained with Daphnia as well as with algae are clearly above 1 mg/L, a long-term fish study is not considered necessary for hazard assessment. Furthermore, according to Annex XI, Section 3 of Regulation (EC) No 1907/2006, a long-term fish study is not considered necessary for hazard assessment. The environmental exposure assessment for the substance indicates no risk for the aquatic compartment (all RCR< 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). Therefore, and for animal welfare reasons, no long-term tests with fish were carried out.
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