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Key value for chemical safety assessment

Additional information

In a reverse gene mutation assay in bacteria (Haddouk, 1999) strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) were exposed to Esterol C (batch 99.06.501) at concentration of, 0, 62.5, 125, 250, 500 and 1000 µg/plate in the presence and absence of mammalian metabolic activation. The positive controls induced the appropriate responses in the corresponding strains. No noteworthy increase in the number of revertants was induced in all tested strains with and without metabolic activation.

In a supporting in vitro assessment of the mutagenic potential of Rapeseed Methyl Ester, histidinedependent auxotrophic mutants of Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant of Escherichia coli, strain WP2 uvrA (pKM101), were exposed to Rapeseed Methyl Ester diluted in dimethyl sulphoxide (DMSO). DMSO was also used as a negative control. Two independent mutation tests were performed in the presence and absence of liver preparations (S9 mix) from rats treated with phenobarbital and 5,6-benzoflavone. The first test was a standard plate incorporation assay; the second included a pre-incubation stage. Concentrations of Rapeseed Methyl Ester up to 5000 μg/plate were tested. No signs of toxicity were observed towards the tester strains in either mutation test. No evidence of mutagenic activity was seen at any concentration of Rapeseed Methyl Ester in either mutation test. 

In a GLP mammalian cell cytogenetic assay (chromosome aberration) (Haddouk, 2000), primary lymphocyte cultures were exposed to Esterol C (batch no. 0006503) at concentration of 18.96, 37.93, 75.85, 151.70, 303.41, 606.82, 1213.64 and 2427.27 µg/ml with and without metabolic activation. Positive controls induced the appropriate response. There was no evidence of chromosome aberration induced over background.

A slight comitogenic activity has been reported in mouse linphoma cells for methyl miristate, but the result is doubt for other tested chainlenghts (Baxter 1981)

To test for possible anticlastogenic effects of fatty acids (Renner, 1986) , the methyl esters of fatty acids — short-chain to long-chain — were examined on busulfan in Chinese hamster bone-marrow cells using the chromosome aberration test. When the experimental animals were treated with fatty acid esters and the mutagen, the chromosome-breaking actions of busulfan were not modulated by the short-chain fatty acids, but the fatty acids from lauric acid (C12) up to nonadecanoic acid (C19) reduced the rate of aberrant metaphases from 9.4 to about 3% at doses of 100 mg/kg and less. Other chemical properties of the fatty acids (saturated or not, number of double bonds, even- or odd-numbered) had no influence on the anticlastogenic effects.

All performed studies on genetic toxicity both in vitro and in vivo, on bacterial and mammalian cells on the substance and on a numer of different members of the category showed negative results. No further test are proposed


Short description of key information:
The substance is not mutagenic

Endpoint Conclusion:

Justification for classification or non-classification

All study results are negative.

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