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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The test substance was not genotoxic when tested in the Ames test with four different strains of Salmonella Typhimurium (TA 98, TA 100, TA 1535, TA 1537) in concentrations of 20, 80, 320, 1280, and 5120 µg/plate similar to OECD guideline 471 (1997) with and without metabolic activation (Ciba-Geigy Ltd no 840436).

In the unscheduled DNA synthesis test according to OECD guideline 482 (1987) primary rat hepatocytes were exposed to test substance concentrations of 0.8, 4, 20, 100, 200, 400 µg/ml in the original experiment and concentrations of 0.2, 1, 5, 10, 20, 50, 100 and 200 µg/ml in a confirmatory experiment for 16 to 18 h (Ciba-Geigy Ltd no. 874225). 400 µg/ml exerted toxicity and was not examined. The mean gross number of silver grains per nucleus was slightly increased in both experiments. Since the increase was not doubled and no dose-response relationship was seen in both experiments, the test article had no genotoxic properties under the experimental conditions used in this study.

After single oral exposure of Chinese hamsters to the test substance at a dose of 2940 mg/kg bw similar to OECD guideline 474 (1997) bone marrow was sampled 16, 24 and 48 h after treatment (Ciba-Geigy Ltd no. 851222). No increased micronucleus frequency in polychromatic erythrocytes was seen after 16 h, 24 and 48 h. The slight reduction of PCE/NCE- Ratio at 2940 mg/kg bw after 48 h (1.58 and 1.01 for control and treatment group) indicates slight cytotoxicity of the test substance on bone marrow.

The test article was administered to Chinese Hamsters at doses of 735, 1470 and 2940 mg/kg bw/d on two consecutive days according to the "Nucleus Anomaly Test in Somatic Interphase Nuclei of Chinese Hamster", which is a modified micronucleus assay (Ciba-Geigy Ltd no. 850413). The following anomalies in the nuclei were registered: Single Jolly bodies (micronuclei in red blood cells), fragments of nuclei in erythrocytes, micronuclei in erythroblasts, micronuclei in leucopoietic cells and polyploid cells. No significant increase in abnormalities was seen at any dose group.

Taken together, no genotoxicity of the test substance under non cytotoxic conditions has to be expected.


Short description of key information:
Valid in vitro and in vivo studies assessing genotoxicity of the test substance are available. In an Ames test conducted similar to OECD guideline 471 no genotoxicity was seen (Ciba-Geigy Ltd 1984). In an unscheduled DNA synthesis test according to OECD 482 a slight increase mean gross number of silver grains per nucleus was seen. However, the mean number of silver grains per nucleus was not doubled and showed no dose-response relationship (Ciba-Geigy Ltd 1987). In an in vivo Micronucleus test similar to OECD guideline 474 no increased incidence of micronuclei in bone marrow cells of Chinese hamster was seen (Ciba-Geigy 851222, 1986). In a Nucleus Anomaly Test in Somatic Interphase Nuclei of Chinese Hamster", which is a modified micronucleus assay, no significant increase in abnormalities was seen (Ciba-Geigy Ltd 1985). Based on the results of these studies the test substance was considered to be not genotoxic.

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 was not considered to be classified for mutagenicity according to Annex I of 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 mutagenicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012).