Registration Dossier
Registration Dossier
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EC number: 234-054-3 | CAS number: 10519-11-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test item did not induce a significant increase in the mutation frequency of Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 at concentrations up to 5000 µg/plate in the presence and 1500 µg/plate in the absence of a metabolising system.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An Ames test was conducted on the test item using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 (2001). The test was performed by the plate incorporation assay at test item concentrations of 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in the presence of S9 and 1.5, 5, 15, 50 and 1500 µg/plate in the absence of S9, alongside negative, solvent and positive controls. The test item was incubated for 48 to 72 hours and mutagenicity was assessed based on the number of revertant colonies. The test item did not induce a significant increase in mutation frequency in any strain at any dose. Therefore the test item is not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolising system. In the absence of S9-mix the test item was bacteriotoxic towards the strains TA1535, TA98, and TA102 at 150 µg/plate and towards the strains TA1537 and TA100 at 500 µg/plate. In the presence of S9-mix the test item was bacteriotoxic towards the strains TA98 and TA102 at 500 µg/plate, towards the strains TA1537 and TA100 at 1500 µg/plate, and towards the strain TA1535 at 5000 μg/plate. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 471.
Justification for classification or non-classification
One key study (Klimisch 1) is available for classification (2001). The test item did not induce a significant increase in mutation frequency in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 at doses up to 5000 µg/plate in the presence of S9 and 1500 µg/plate in the absence of S9. Therefore, the test item is not considered to be mutagenic.
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