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Administrative data

Key value for chemical safety assessment

Additional information

In-vitro:

- Gene mutation in bacteria:

The substance was tested for mutagenic activity in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2uvrA at concentrations ranging from 312.5 to 5000 µg per plate (OECD 471, GLP) (Ciba-Geigy 1992c). The tests were conducted, using the preincubation method, on agar plates in the presence and absence of an Aroclor 1254 induced rat liver preparation and co-factors (S9 mix) required for mixed-function oxidase activity. Positive control compounds demonstrated the sensitivity of the assay and the metabolising, potential of the S9 mix. The test was performed without detection of any toxic and/or mutagenic effects. The values of the negative controls were found to be within the acceptable range and the values of the positive controls met the criteria for a positive response. These results confirm the correct performance of the test.

 

- Clastogenicity in mammalian cells:

The test substance was tested for clastogenic effects on Chinese hamster ovary cells in vitro (OECD 473, GLP) (Ciba-Geigy 1992d). The highest concentration of the test material in the experiments without and with metabolic activation was 750 µg/ml in DMSO.

The highest concentration of 93.75 µg/ml selected for analysis in the first experiment of the original study caused 60.89 % suppression of mitotic activity. The highest concentration of 187.5 µg/ml selected for analysis in the second experiment of the original study caused 64.29 % suppression of mitotic activity. In the third experiment of the confirmatory study with a 42 hours treatment period the highest concentration of 93.75 µg/ml selected for analysis caused 33.67 % suppression of mitotic activity. At the next higher concentration, mitotic activity was suppressed by 95.02%. In the fourth experiment (3 hours treatment / 39 hours recovery) the highest concentration of 93.75 µg/ml selected for analysis caused no suppression of mitotic activity. At the next higher concentration, mitotic activity was suppressed by 97.66% and was therefore not scorable. No indication of a clastogenic effect was observed in any of the experiments.


Short description of key information:
Ames test: negative: OECD Guideline 471, GLP
Chromosome aberration in CHO cells: negative: OECD Guideline 473, GLP

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genetic toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genetic toxicity under Regulation (EC) No. 1272/2008.