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Key value for chemical safety assessment

Additional information

Bacterial reverse mutation (Ames test): Positive


Only a single summary report on a parallel study with the concentrated test material (92.2%) and a dilute solution (15.2%) is available (Callander 2004). It was conducted according to guideline OECD 471 in a GLP-certified testing facility, following UK and OECD principles of GLP, but without GLP inspections for this particular study. Only two S. typhimurium strains (TA98 and TA100) were tested with and without metabolic activation. The experimental details and the results are only documented in a summary manner. Although a full study report is not available, the results are sufficiently detailed and unambiguous. The study is considered to be relevant, reliable (Klimisch 2) and adequate for the purposes of classification and labelling.


Positive (mutagenic) responses were elicited by the concentrated test material in both strains of S. typhimurium, TA 98 and TA 100, with and without metabolic activation. The diluted solution caused a positive response only in TA 100 (with and without S9 mix). It is therefore concluded that the test material is mutagenic, and that further testing of bacterial mutagenicity is not necessary.


 


Cytogenetic test (chromosome aberration): No data available


Short description of key information:
Ames test: positive (mutagenic), S. typhimurium TA98 and TA100 with + without metabolic activation, OECD 471, Callander 2004

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available study investigated whether the test substance induced gene mutation in certain strains of the bacteria. The study is considered to be relevant, reliable (Klimisch 2) and adequate for the purposes of classification and labelling.

The test substance showed positive results in an in vitro bacterial gene mutation assay. In accordance with Directive 67/548/EEC as amended and in accordance with Regulation (EC) No. 1272/2008, Annex I, 3.5.2, based on the available data the test substance is not considered to be classified as mutagenic. The endpoint is not considered to be conclusive.

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