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Toxicological information

Carcinogenicity

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Description of key information

Key value for chemical safety assessment

Additional information

To evaluate the cancerogenic potential of beta-ionone female mice were initiated once with a solution of 0.125 mg 7,12-dimethylbenz[a]anthracene (DMBA) dissolved in 0.25 ml acetone applied to their backs (Shamberger, 1971). Three weeks later 0.25 ml of β-ionone at a concentration of 0.04 % (ca. 4 mg/kg bw) or a mixture of 0.006 % croton resin as tumor promotor and the test material dissolved in acetone was applied to animal skin five times weekly for 18 weeks. The animals were examined weekly and the number and distribution of local tumors were noted. The animals were shaved twice monthly and weighed at monthly intervals during the experiment. The group that received DMBA and the tumor promotor were the positive control group. The negative controls received DMBA or acetone only. The study showed, that β-Ionone had no significant effect on the incidence of tumors whereas the positive controls showed the expected results (DMBA plus croton resin resulted in 90 % animals with tumors). However, the study used a relatively short application period and only one low concentration was tested. Thus, these data alone are not sufficient to evaluate the carcinogenic potential. Supportively, the histological data of the subchronic 90-days study (BASF AG, 2004) as well as the negative results for genetic toxicity in vivo and in vitro (Givaudan, 2004; BASF AG, 2003) do not provide any indication of carcinogenicity

Justification for classification or non-classification

Because there is no indication of carcinogenicity, no classification is required.