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Description of key information

9DDAME is not expected to pose a risk of carcinogenicity

Key value for chemical safety assessment

Justification for classification or non-classification

No carcinogenicity classification is warranted for 9-dodecenoic acid, methyl ester (9-DDAME) according to Regulation (EC) No 1272/2008 based on negative results in the Ames test and read across evidence from genotoxicity studies and a 90 day repeat dose oral study of 9-decenoic acid, methyl ester (9-DAME).

Additional information

There are no lifetime animal studies available on 9 -dodecenoic acid, methyl ester (9DDAME) in order to directly investigate its possible carcinogenic activity. However, 9DDAME gave negative results in the Ames test. In addition, using the read across approach,

9-decenoic acid, methyl ester (9DAME) gave negative results in the in vitro genotoxicity studies and in a 90 day repeat dose study there was no evidence that 9-decenoic acid, methyl ester (9-DAME) was able to induce hyperplasia or pre-neoplastic lesions.