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EC number: 203-929-1
CAS number: 112-03-8
A study was conducted to determine the in vitr ogenetic toxicity
of the test substance according to a method similar to OECD Guideline
471, in compliance with GLP. Salmonella typhimurium strains TA97,
TA98, TA100 and TA1535 were treated with the test substance using the
Ames plate incorporation method. Tests were carried out in triplicate,
both with and without the addition of metabolic activation (S9-mix). The
concentration range of the test substance was 0.8 to 2,500 µg/plate.
Cytotoxicity was observed at ≥100 µg/plate. No significant increase in
the frequency of revertant colonies was recorded for any of the
bacterial strains at any of the test substance concentrations tested,
either with or without metabolic activation.Under
the study conditions, the test substance was not mutagenic in Salmonella
typhimurium strain TA97, TA98, TA100 or TA1535, with or without
metabolic activation (Muller, 1995).
study was conducted to determine the in vitro genetic toxicity of
the read across substance, cetrimonium chloride (C16 TMAC), according to
OECD Guideline 476, in compliance with GLP. This experiment was
performed at the HPRT locus in V79 Chinese hamster cells. All positive
controls showed a distinct increase in the number of mutant colonies. No
substantial and reproducible concentration-dependent increases in the
mutation frequency at the HPRT locus, was seen in test
substance-treatment cells either with or without metabolic activation.
Based on the results of the read across study, the test substance was
considered to be non-mutagenic both with and without metabolic
activation (Wollny, 2007).
A study was conducted to determine the in vitro genetic toxicity
of the read across substance, cetrimonium chloride (C16 TMAC), according
to OECD Guideline 473 and EU Method B.10, in compliance with GLP. The
experiment was performed in V79 Chinese hamster lung cells. The
concentration range of the test substance was determined in a
pre-experiment using the plating efficiency assay as an indicator of
toxicity response. Cells were exposed for 7, 18 or 28 hours at
concentrations levels of 0.0 to 10.0 µg/L test substance with or without
metabolic activation. Treatment with 3.0 µg/mL and 10.0 µg/mL completely
reduced the plating efficiency of the V79 cells. The mitotic index was
reduced after treatment with the highest concentration at each fixation
interval in the presence and absence of S9 mix. Positive controls showed
a distinct increase in the number of cells with structural chromosome
aberrations. There was no relevant increase in cells with structural
aberrations after treatment with the test substance at any fixation
interval either without or with S9 mix. Based on the results of the read
the test substance did not induce structural chromosome aberrations in
the V79 Chinese hamster cell line with and without metabolic activation
waiving since the test substances were negative inin
vitroassays (i.e. bacterial and mammalian mutagenicity
assays as well as a chromosome aberration assay). Therefore, an in
vivo mutagenicity test is not required.
Based on the
in vitro genotoxicity data,
classification of C18 TMAC for genotoxicity according to Directive
67/548/EEC and Regulation (EC) 1272/2008 is not required.
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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