Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic potential of the test substance was evaluated in two Salmonella/microsome tests with the S. typhimurium strains TA 98, TA 100, TA 1535, 1538 and TA 1537 in the presence and absence of S9 mix in a test protocol generally following OECD TG 471. Deviation from guideline was the absence of a strain which detects cross-linking mutagens (e.g. TA 102). Both tests, a plate incorporation and the preincubation test, with up to and including cytotoxic and precipitating concentrations indicate that the test substance is not a mutagen in the Ames Salmonella/microsome test.

To investigate the potential of the test item to induce chromosomal breakage (structural chromosomal aberrations) or misdistribution of chromosomes (aneuploidy) in vivo, a bone marrow micronucleus test was performed on mice. Ten male and ten female mice in the high dose group and 5 males/females in the mid and low dose group were treated intraperitoneally with single doses of 500, 1000, or 2000 mg/kg bw. Control animals (10 males/ 10 females) were given the vehicle (Myrj 52) in the same manner. The test item showed neither a biologically relevant nor statistically signficant increase in micronucleated polychromatic (PCE) and normochromatic erythrocytes (NCE) as compared to the negative control at either of the two sampling times (24 and 48 hours). The decrease of the PCE/NCE ratio indicated bone marrow depression induced by toxicity of the test substance. One male mouse died in the high-dose group. Thus, the test substance was negative in the mouse bone marrow micronucleus assay up to the recommended and toxic dose level of 2000 mg/kg bw.

Short description of key information:
Two gene mutation assays in bacteria (Ames plate incorporation and preincubation bacterial reverse mutation assays, GLP, comparable to OECD TG 471): negative in the Salmonella typhimurium strains TA 1535, TA 1537, TA 100, TA 1538 and TA 98 with and without S9 mix up to and including cytotoxic concentrations
Chromosome aberration in vivo (mouse micronucleus test, GLP, comparable to OECD TG 474): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.