Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

For this endpoint 5 tests, performed according/similar to test guidelines and under GLP conditions were selected as key studies:

- One Bacterial Reverse Mutation Assay, performed according to OECD 471 (King and Harnasch, 1999). Ethylhexyl Methoxycinnamate was negative in these valid bacterial cell mutation assay.  

- An in vitro mammalian cell transformation assay using Balb/c 3T3 cells (Strobel, 1985, according to IARC/NCI/EPA Working Group (1985) Cellular and molecular mechanisms of cell transformation and standardization of transformation assays of established cell lines for the prediction of carcinogenic chemicals: overview and recommended protocols, Cancer Res., 45, 2395-2399). Ethylhexyl Methoxycinnamate did not induce cell transformation in mammalian cells in vitro.

- A DNA damage and repair assay, unscheduled DNA synthesis (UDS) in mammalian cells (i.c. freshly prepared rat hepatocytes) in vitro (Strobel, 1985, similar to OECD Guideline 482). Ethylhexyl Methoxycinnamate did not induce DNA damage resulting in unscheduled DNA synthesis in cultured rat hepatocytes.

- A Mammalian Erythrocyte Micronucleus Test in vivo using a Füllinsdorf Albino SPF, outbred strain of mice (Hugentobler, 1983, similar to OECD Guideline 474). After twofold oral application of 1000, 2500 and 5000 mg/kg bw, Ethylhexyl Methoxycinnamate induces neither chromosome breaks nor mitotic non-disjunctions in bone marrow cells of mice.

The following tests are considered supporting studies, performed similar to test guidelines, and under GLP conditions:

1) In vitro Mammalian Chromosome Aberration Test (Hugentobler, 1984, similar to OECD Guideline 473), using human peripheral blood lymphocytes. In absence as well as in presence of a metabolic activation system the results were negative, being not clastogenic.

2) In vitro Mammalian Cell Gene Mutation Test (Strobel, 1983, similar to OECD Guideline 476, 1997). In this test evaluation was performed for induction of mutations at the hypoxanthine guanine phosphoribosyl transferase (HGPRT) locus in the established cell line V79, derived from Chinese hamster lung cells. In absence as well as in presence of a metabolic activation system Ethylhexyl Methoxycinnamate did not induce mutations.

Short description of key information:
- Gene mutation in bacteria (Bacterial Reverse Mutation Assay/Ames): not mutagenic (OECD 471).
- In vitro mammalian cell transformation assay: not genotoxic (IARC/NCI/EPA Working Group (1985).
- In vitro DNA damage and repair assay (unscheduled DNA synthesis (UDS) in mammalian cells): not mutagenic (OECD 482).
- In vivo cytogenicity test (Mammalian Erythrocyte Micronucleus Test): not mutagenic, not clastogenic (OECD 474).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Provided key and supporting studies with 2 -Ethylhexyl 4 -Methoxycinnamate did not show any genotoxic potential. Therefore, it can be concluded that the substance is not mutagenic and therefore does not need to be classified for mutagenicity according to the criteria outlined in 1272/2008/EC (CLP/EU-GHS).