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Long-term toxicity to fish

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Due to the unstable nature of organic peroxides, it can be assumed that upon contact with water and organic matter, tert-butyl peroxypivalate undergoes rapid degradation resulting in the formation of respective alcohols and acids. Therefore, tert-butyl peroxypivalate is considered to be not stable in aquatic environment. In addition, the substance is not expected to have a potential for bioaccumulation (calculated BCF using EPIWIN = 32.57 L/kg wwt). 
The performance of a test for the assessment of long-term toxicity to fish was waived /considered not justified in accordance with the organic peroxides consortium’s position paper “Adaption of the Assessment Factor for Aquatic PNEC Derivation for Organic Peroxides - Low acute to chronic ratio” (author: CEHTRA, Report no. CFR-12.012, cf. attachment in IUCLID section 13).
A short-term to long-term toxicity extrapolation is considered as allowable since it was clearly shown that for fish species the ratio between short-term to long-term toxicity based on EC10 values (Acute to chronic ratio, ACR) is 1.9 (mean value). EC10 values were used as chronic values, since these regression based point estimate values are statistically derived and in particular based on biological effects.
Based on this estimation approach for the long-term toxicity the PNEC derivation will be performed.
In accordance with the document "Guidance on information requirements and chemical safety assessment, Chapter R.7b: Endpoint specific guidance"
section "R.7.8.5.3 Conclusions on chemical safety assessment (PNEC derivation)" (cf. Figure R.7.8-4) long-term tests for toxicity to fish do not have to be performed since the standard testing data on short-term toxicity for three trophic levels are available and both exposure assessment and risk characterization do not identified a risk. Furthermore, an LC50 from a short-term toxicity testing on fish according to OECD 203 (cf. IUCLID section 6.1.1) can be used directly for PNEC assessment.

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