Methyl cinnamate

Endpoint summary

Additional information

In vitro

Methyl cinnamate was found negative for inducing gene mutations in three in vitro studies (Ames test according to OECD 471, Sister Chromatid Exchange test in mammalian cells according to OECD 479 and Mammalian Cells Gene Mutation test according to OECD 476) conducted in the presence and absence of metabolic activation. The Ames test studied four mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98, and TA100) with and without liver homogenate (S9) as well as E. coli WP2 with and without liver homogenate (S9) in test concentrations up to 5000 µg per plate. No increase in revertant colony numbers of any of the five tester strains was observed following treatment with methyl cinnamate at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.

Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.

In conclusion, these results indicated that test article was not mutagenic to Salmonella typhimurium strains TA1535,TA1537, TA98, and TA100 or to E. coli WP2 in the absence and presence of a metabolic system.

 

The second in vitro study was performed to evaluate the mutagenic potential of methyl cinnamate based upon its ability to affect the cell cycle or to induce sister chromatid exchange in Chinese hamster ovary (CHO) cells according to OECD guideline 479. The test article was applied up to 100 µM. In the assay, based on the results given in this study, methyl cinnamate, was found to have a slight enhancing effects on MMC-induced SCEs but dose response was unclear. However, methyl cinnamate itself did not affect the cell cycle or induce spontaneous SCEs and thus is considered negative in this test.

 

The third in vitro study was performed to investigate the potential of methyl cinnamate to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster according to OECD guideline 476.The test article was applied up to 1622 µg/ml in the pre-test and up to 1200 µg/ml in the two main tests. No substantial and reproducible dose dependent increase of the mutation frequency was observed in either of the main experiments. Thus, the test item did not induce gene mutation effects at the HPRT locus in V79 cells.

In vivo

As all three in vitro tests were negative, in vivo data are not required.

Justification for selection of genetic toxicity endpoint
All three available in vitro tests contribute to the final assessment for the substance being considered negative inducing gene mutations.

Short description of key information:
Based on the available data, test article was found negative inducing gene mutagenicity under the experimental conditions of three in vitro tests .

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Methyl cinnamate does not have to be classified for mutagenicity according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) because it did not reveal any mutagenic effect in the bacterial reverse mutation assay in the presence or absence of metabolic activation, in the mammalian cell gene (HPRT) mutation test in V79 cells or in an in vitro sister chromatid exchange test in CHO cells.