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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Valid experimental data were available to assess the genetic toxicity of the test substance in-vitro and in-vivo.



- Gene mutation in bacteria:

The test substance was tested for mutagenic activity in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA102 at concentrations ranging from 20 to 5000 µg per plate (CIBA 1986f). The tests were conducted, using the plate incorporation 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 results obtained in both experiments were similar. No mutagenic activity was observed in any of the 5 bacterial strains, in either activation condition. Precipitation was observed at 78 µg per plate and above. Toxicity was not found with all the strains.


In vivo:

The in vivo genotoxic potential of the test substance was evaluated in a micronucleus test in bone marrow erythrocytes of young, male and female chinese hamsters following a oral administration (i.p.) and sampling times of 16, 24 and 48 h (CIBA 1986g). A toxicity study was undertaken to establish a suitable dose range for the micronucleus experiment. Based on the findings of the toxicity study, the maximum tolerated i.p. dose of the test substance was determined to be 5000 mg/kg bw. Bone marrow samples were taken 16, 24 and 48 h after the initial 0 h dose. The bone marrow smears from animals treated with the dose of 5000 mg/kg of the test substance showed no statistically significant increase (p<0.05) in the number of micronucleated polychromatic erythrocytes compared to the negative control animals at all three sampling times. The respective "positive control" experiments with cyclophosphamide (64 mg/kg) yielded an average of 2.37% polychromatic erythrocytes with micronuclei. This is significantly different from the controls (0.06%) treated with the vehicle (0.5% CMC) alone. It is concluded that under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated with the test substance.

Short description of key information:
in vitro: Ames test: negative; OECD 471, Ciba 1986f
in vivo: Micronucleus test: negative; similar to OECD 474, Ciba 1986g

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.