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EC number: 224-809-5 | CAS number: 4500-29-2
No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated (with and without metabolic activation) in experiment I.
Toxic effects of the test item were noted in tester strains TA 98, TA 100, TA 1535 and TA 1537 in experiment II at a concentration of 5000 µg/plate (without metabolic activation).
In order to investigate the potential of the test item for its ability to induce gene mutations, a plate incorporation test (experiment I) and a pre-incubation test (experiment II) were performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102. The submission substance was tested in two independent experiments at concentrations of 31.6, 100, 316, 1000, 2500 up to the limit of 5000 µg/plate with and witout metabolic activation. All concentrations were tested in triplicate.
No toxic effects of the test item were noted in any of the tester strains up to the highest dose evaluated with and without metabolic activation in experiment I. In experiment II, cytotoxicity were noted in tester strains TA 98, TA 100, TA 1535 and TA 1537 without metabolic activation at the limit concentration of 5000 µg/plate.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed folowing teratment at any concentration level, neither in the presence nor in the absence of metabolic activation in experiment I and II. The positive controls induced distinct increases of revertant colonies indicating the validity of the experiment.
In conclusion it can be stated that the test item did not cause gene mutations by base pair changes or frameshifts in the genome of any of the tester strains used. Therefore, the submission substance is considered to be non-mutagenic in this bacterial reverse mutation assay.
The submission substance was tested for potential point mutation in a guideline conform bacterial reverse mutation assay (Ames test) according to OECD TG 471 with and without metabolic activation. Independent experiments using several test concentrations up to the limit dose of 5000 µg/plate did not cause gene mutations by base pair changes or frameshifts in the genome of any of the tester strains used. Therefore, the submission substance is considered to be non-mutagenic in this bacterial reverse mutation assay. This study was selected as key study.
The submission substance was tested for potential gene mutation in a guideline conform mammalian cell gene mutation assay (HPRT locus) according to OECD TG 476 in V79cells of the Chinese hamster. Independent experiments were performed using several test concentrations up to the limit of 5000 µg/mL(with and without metabolic activation). No biologically relevant increase of mutants was found after treatment with the test item, neither with nor without metabolic activation. No dose-response relationship was obeserved. Therefore, the submission substance is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese hamster. This study was selected as key study.
The submission substance was tested for the potential to induce structural chromosome aberrations in an guideline conform in vitro cytogenetic assay in Chinese hamster V79 cells according to OECD TG 473. Two independent experiments with and without metabolic activation were carried out using test item concentrations up to the limit of 5000µg/mL. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative controls. No biologically relevant increase of the aberration rates and no biologically relevant increase in the frequencies of polyploid cells were noted after treatment with the test item with as compared to the controls. EMS and CPA were used as positive controls and induced distinct and biologically relevant increases in cells with structural chromosomal aberrations. The test item did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line and is thus considered to be non-clastogenic in this test. This study was selected as key study.
In conclusion, the submission substance is found to be not mutagenic in the bacterial reverse mutation assay, the mammalian (HPRT) mutation test in V79 cells and in the in vitro chromosome aberration test in V 79 cells.
Based on the available data from three independent mutagenicity assays, a respective mutagenic potential of the test item can most probably be excluded. Thus, the submission substance do not have to be classified for mutagenicity in accordance with the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) as well as in the EU Classification, Labellling and Packaging Regulation (1272/2008/EC).
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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