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EC number: 923-900-3 | CAS number: -
The test substance was investigated in a bacterial reverse mutation (Ames) test according to OECD TG 471 on Salmonella typhimurium TA 1535, TA 100, TA, 1537, TA 98, and TA 102. The test substance was considered to be non-mutagenic without and with S9 mix in the initially performed plate incorporation as well as in the preincubation modification, performed as independent repeat.
The test substance was tested in an in vitro gene mutation assay in V79 cells (HPRT) according to OECD TG 476. The highest concentration used (200 µg/mL) was limited by the solubility in the solvent and in the medium. Precipitation in the medium was observed starting at 100 µg/mL. No relevant toxic effects occurred up to the maximal concentration of 200 µg/mL. Without and with S9 mix the test item induced no substantial and reproducible dose dependent increase of the mutant frequency. The positive controls ethyl methanesulfonate and dimethylbenzanthracene induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the S9 mix. Based on these results, the test substance is considered to be non-mutagenic in the V79/HPRT-assay.
The clastogenic potential of the test substance was evaluated in a chromosome aberration test on Chinese Hamster V79 cells according to OECD TG 473 with concentrations up to 224 µg/mL without and with S9-mix for the 4 -hour treatment period and without S9-mix for the 18 -hour treatment period. Without and with S9-mix cytotoxic effects were not observed up to 224 µg/mL after 4 hours treatment or after 18-hour treatment. Precipitation in the medium occurred at 224 µg/mL.
None of the cultures treated with the test item in the absence and in the presence of S9-mix showed biologically relevant or statistically significant increased numbers of aberrant metaphases, therefore the test substance is considered not to be clastogenic for mammalian cells in vitro.
The substance did not show genetic toxicity in two in vitro gene mutation assays according to OECD TG 471 and OECD TG 476 (Ames and HPRT, respectively) and in an in vitro chromosome aberration assay according to OECD TG 473, all conducted without and with a metabolic activating system.
No classification required for genetic toxicity according to Regulation (EC) No 1272/2008, Annex I.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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