Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ames test

The mutagenic potential of the test substance was investigated in an Ames test similar to OECD TG 471 (Ciba-Geigy, 850046, 1985), performed on Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of a metabolic activation system (S9 mix). None of the tested concentrations (20 - 5000 µg/plate) led to an increase in the incidence of histidine-prototrophic mutants by comparison with the negative control either with or without metabolic activation. Owing to a growth-inhibiting effect of the substance a reduction in the colony count was observed in the experiments without microsomal activation at the highest concentration. This result was confirmed in a second independent experiment. Therefore, based on the results of these experiments and on standard evaluation criteria, it is concluded that the test article and its metabolites did not induce gene mutations in the strains of S. typhimurium and E. coli used.

In vivo nucleus anomaly test

The test article was investigated for its clastogenic potential in an in vivo nucleus anomaly test performed in Chinese hamsters similar to OECD TG 474 (Ciba-Geigy, 850047, 1985). The test substance was administered by gavage in daily doses of 1250, 2500 or 5000 mg/kg on each of two consecutive days. The animals were sacrificed 24 h after the second application and smears from the bone marrow were made. Treatment with the test article with the various doses did not result in significant increases in nucleus anomalies when compared to the control. By contrast, a "positive control" experiment with cyclophosphamide (128 mg/kg) yielded 8.08% cells with anomalies of nuclei. This is significantly different from the controls (0.08%) 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:
The substance was not mutagenic in the Ames test in Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537, tested both in the absence and presence of S9 mix (Ciba-Geigy 1985). No clastogenic potential was observed in an in vivo micronucleus test in hamsters (Ciba-Geigy 1985).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the present data, classification for genotoxicity is not warranted under Directive 67/548/EEC.

 

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for genotoxicity is not warranted under Regulation (EC) No.1272/2008.