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Toxicological information


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Administrative data

Description of key information

No relevance of carcinogenic effect/potential

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

No classification for carcinogenicity warranted under 67/548/EEC or Regulation 1272/2008.

Additional information

Methyl 12 -oxo-trans-10 -octadecenoate and methyl hydroxyoctadecadienoate were tested for carginogenic and tumor promoting activity on mouse skin (Arffmann and Glavind, 1971 and 1974). Methyl oleate, which was inactive in the preliminary screening was also tested. No safe evidence of any proper carcinogenic effect of the fatty acid esters was found; some degree of tumor promoting activity could be further investigated

By the same working group (Arffman and Glavind 1975) two fatty acid methyl esters, methyl oleate and methyl 12-oxo-trans-10-octadecenoate, have been tested for carcinogenicty by oral and subcutaneous administration in ST/a mice of both sexes. A positive effect of methyl oleate could not be assessed, while the results pointed to a promoter effect of methyl oxo-octadecenoate. Given in the diet, this compound increased the incidence and number of forestomach papillomas within 83 weeks after initiation by 4-nitroguinoline 1-oxide.

In a more comprehensive study (Swer et al., 1970) twenty-nine fatty acids and esters, lactones, and epoxy and peroxy compounds were tested for carcinogenic activity by repeated s.c. injections in mice. Sarcomas at the site of injection were elicited with 12-hydroxystearic acid , methyl 12-hydroxystearate, 4-ketostearic acid, stearohydroxamic acid , glycidyl laurate, glycidyl oleate, and p-nitroperoxybenzoic acid. Sarcomas were also elicited in mice given injections of lower doses of stearic acid and gamma-stearolactone. No carginogenic activity was recorded for methyl stearate.

After having assessed the whole category for all toxicological end points, and having verified no concern in any assessment, a consistent behaviour in respect of carcinogenicity can be previwed for Fatty acids C16 -C18 and C18 unsatd. methyl esters. No further testing on carcinogenicity is proposed and no classification is warranted under 76/548/EEC or Regulation 1272/2008