Registration Dossier
Registration Dossier
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EC number: 220-813-6 | CAS number: 2905-62-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Non mutagenic with and without metabolic activation, bacterial reverse mutation assay, OECD 471 and EU Method B.13/14, Verspeek-Rip (2015)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The mutagenic activity of the test material was evaluated in a bacterial reverse mutation assay conducted in accordance with the standardised guidelines OECD 471 and EU Method B.13/14 under GLP conditions. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).
Salmonella typhimurium strains TA1535, TA1537, TA100 and TA98 and Escherichia coli strain WP2uvrA were exposed to the test material in two independent experiments; a direct plate assay was performed followed by a pre-incubation assay, both in the absence and presence of metabolic activation (S9-mix).
In a dose range finding study, the test material was initially tested up to concentrations of 5000 μg/plate in acetone in the strains TA100 and WP2uvrA in the direct plate assay. The test material precipitated on the plates at dose levels of 512 μg/plate and above. Toxicity was observed in both tester strains.
In the first mutation experiment, the test material was tested up to concentrations of 1600 μg/plate in the strains TA1535, TA1537 and TA98. The test material precipitated on the plates at dose levels of 512 μg/plate and above. Toxicity was observed in all tester strains.
In the second mutation experiment, the test material was initially tested up to concentrations of 1600 μg/plate in the strains TA100 and WP2uvrA in the pre-incubation assay. The test material precipitated on the plates at the dose level of 1600 μg/plate. Toxicity was observed in both tester strains.
In the main experiment, the test material was tested in the strains TA1535, TA1537 and TA98 up to concentrations of 890 and 512 μg/plate in the absence and presence of S9-mix, respectively. The test material did not precipitate on the plates at the top dose of 890 μg/plate. Toxicity was observed in all tester strains, except for the tester strain TA98 in the presence of S9-mix.
The test material did not induce a significant dose-related increase in the number of revertant colonies in any of the strains both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
In this study, acceptable responses were obtained for the vehicle and positive controls, indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Under the conditions of the study, the test material was determined to be non-mutagenic in both the presence and absence of metabolic activation.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to genetic toxicity.
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