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Toxicological information

Carcinogenicity

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Description of key information

No data is available on the carcinogenicity potential, neither for dialkyldimethylammonium chlorides in general nor for di-C16-18-alkyldimethylammonium chloride in particular. However, negative data from mutagenicity testing assessing gene mutation and chromosomal damage as well as limited data from repeated dose toxicity studies in animals do not give a concern that dialkyldimethylammonium chlorides such as di-C16-18-alkyldimethylammonium chloride may have a carcinogenic potential.

Key value for chemical safety assessment

Additional information

Negative data from the series of in vitro genotoxicity tests assessing gene mutation and chromosomal damage as well as limited data from repeated dose toxicity tests in animals do not give a concern that quaternary ammonium compounds, di-C16 -18 -alkyldimethyl, chloride may have a carcinogenic potential.

Moreover, two evaluation reports on the structural closely related DidecylDimethylAmmonium Chloride (DDAC) have been recently published by the European Competent Authorities and conclude that the substance was not carcinogenic in an appropriate study (Document I- Draft Evaluation reports in the frame of the directive 98/8/EC concerning the placing of biocidal products on the market - DDAC CAS 7173 -51 -5- Product type 8 - RMS Italy, July 2007 and April 2010).

Based hereupon respective classification is not warranted. This conclusion is in line with the existing EU risk assessment on dimethyldioctadecyl ammonium chloride (DODMAC).

Justification for classification or non-classification