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EC number: 406-040-9 | CAS number: 125643-61-0
The test article was tested in an in vivo micronucleus test (MNT) according to the OECD TG 474 (1983) using Chinese hamster. The test item was administered by single gavage at a dose of 5000 mg/kg bw, which had been selected based on a preliminary tolerability test. The treated animals were sacrificed 16, 24 and 48 hours thereafter. From the bone marrow smears were made and evaluation of any mutagenic effect of the test item on polychromatic erythrocytes as manifested by micronuclei was done.
At all three sampling times, no statistically significant increase in the number of micronucleated polychromatic erythrocytes in comparison with the negative control animals could be evidenced. The respective positive control with cyclophosphamide (64 mg/kg bw) yielded an average of 2.0% polychromatic erythrocytes with micronuclei. This was significantly different from the negative vehicle controls (0.03%). It is concluded that no evidence of mutagenic effects was obtained in Chinese hamsters treated with the test article in the MNT.
In the presence and absence of rat liver S-9-microsomal activation system and at doses of 313-5'000 micrograms per plate, S-typhimurium strains TA 98, TA 100, TA 1535, and TA 1537 as well as E. coli strain WP2uvrA were tested for the induction of base-pair substitutions and frameshift mutations. The study was performed according to OECD testing guideline 471 and under GLP. No evidence of a mutagenic potential associated with the test substance was observed (Ciba-Geigy, 1989).
Chinese hamster ovary cells were treated in vitro at concentrations up to 1000 µg/ml with and without microsomal activation. The treatments lasted with microsomal activation for 3 hours and the expression periods were 15 hours and 39 hours (treatment periods not included). In the experiment without microsomal activation the combined treatment and expression periods lasted for 18 and 42 hours. The analysis of the metaphases from tests with and without microsomal activation revealed no evidence for a clastogenic effect. The procedure followed OECD Guideline 473 and the principles of GLP (Ciba-Geigy, 1993)
In vivo micronucleus test
The substance was administered orally to groups of 24 female and 24 male animals each in the negative and in the 5'000 mg/kg dose group. The positive control group consisted of 8 female and 8 male animals. Treatment occurred in a single application. 16, 24 and 48 hours after application 8 female and 8 male animals per sampling time were sacrificed and bone-marrow smears were prepared. The procedure followed OECD Guideline 474 and the principles of GLP. No evidence of a mutagenic potential associated with the test substance was observed (Ciba-Geigy, 1989).
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for mutagenicity under Directive 67/548/EEC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008.
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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