Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo, other
Data waiving:
other justification
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Study name / type:
Composition 1
Composition 2
Composition 3
Endpoint conclusion:
no adverse effect observed (negative)
Study name / type:
Composition 1

In vitro:

Study 1. 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 2.A 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).

Study 3. 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 across study, the test substance did not induce structural chromosome aberrations in the V79 Chinese hamster cell line with and without metabolic activation (Heidemann, 1989).

In vivo:

Data 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 available negative in vitro genotoxicity data, classification of C18 TMAC for genotoxicity according to Directive 67/548/EEC and Regulation (EC) 1272/2008 is not required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion