Registration Dossier
Registration Dossier
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EC number: 700-371-5 | CAS number: 178535-25-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The mutagenicity test ((May, K., 2002) of Ethylbenzene, manuf. of, distn. residues, distn. lights. was investigated in an Ames test using S. typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2uvrA-/PKM101. Three replicate plates of each strain were exposed to the test material at concentrations of 5, 15, 50, 150, 500, 1500 and 5000 ug/plate in the presence and absence of an exogenous metabolic activation system. There was no evidence of cytotoxicity at the limit concentration in the first test (range-finding assay). The second test was performed at
50, 150, 500, 1500 and 5000 ug/plate.
However, toxicity was seen in the second test at 5000 µg/plate. Thinnning of the background lawn of non-revertant colony numbers over control counts was reported at 5000 ug/plate. Exposure to the test material did not induce increased numbers of revertant colonies of any strain. Appropriate positive control compounds induced large increases in the numbers of revertant colonies, confirming the sensitivity of the assay. Results were confirmed in an independently-repeated assay. No evidence of mutagenicity was seen under the conditions of this study.Short description of key information:
The genetic toxicity study was carried out according to OECD guideline 471 (Salmonella/Mammalian-Microsome Plate Incorporation Mutagenicity Assay (Ames test) with a confirmatory assay) and EU method B13/14 is negative in the presence and in the absence of metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the limited data available (only an Ames test), Ethylbenzene, manuf. of, distn. residues, distn. lights. is not considered to be mutagenic. However, further data is required to confirm this. Therefore, Ethylbenzene, manuf. of, distn. residues, distn. lights. is not expected to be mutagenic according to Directive 67/548/EEC and Regulation (EC) No 1272/2008.
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