Oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane

Endpoint summary

Additional information

To assess the mutagenicity of EP-4000S results from three tests were used.

In the Reverse Mutation Assay: "Ames test" (Safepharm Laboratories Limited, 1997) the test material was tested up to the maximum recommended dose level of 5000 µg/plate. The mutagenic responses were predominantly observed to those tester strains sensitive to base-pair substitution in the genetic material.

EP-4000S was considered to be mutagenic under the conditions of this test.

The Chromosome Aberration Test (Huntingdon Life Sciences, 2012) was performed to assess the ability of EP-4000S to induce chromosomal aberrations in human lymphocytes cultured in vitro. The highest final concentration of EP-4000S used for testing was 3450 μg/mL. In order to determine the toxicity to cultured human lymphocytes, the mitotic index was assessed for all cultures treated with the test substance and the vehicle control, ethanol.

It is concluded that EP-4000S has shown evidence of causing an increase in the frequency of structural chromosome aberrations in this in vitro cytogenetic test system, under the experimental conditions described.

EP-4000S was also tested for mutagenic potential in an In vitro mammalian cell mutation assay (Huntingdon Life Sciences, 2012). Toxicity was observed in the preliminary toxicity test. It was concluded that EP-4000S demonstrated mutagenic potential in this in vitro cell mutation assay, under the experimental conditions described.

This registration dossier has been prepared for tonnage band of up to 10 tonnes/year. An in-vitro bacterial reversre mutation test was conducted as required by Annex VII of REACH. As the initial test in bacteria was positive for mutagenic effects, further in-vitro testing was conducted (chromosome aberration and mammalian cell mutation tests as described above) within the scope permitted by Annex VII. Although the available tests all indicate mutagenic activity, in-vivo testing will not currently be considered on the basis that it is not warranted at this tonnage band; in the case that the tonnage band were to exceed 10 tonnes/year then in-vivo testing could be considered within the scope of Annex VIII of REACH.

Short description of key information:
EP-4000S was considered to be mutagenic.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

As noted above, three in-vivo tests (including two tests in mammalian cells) indicated mutagenic activity in EP-4000S. The available results indicate a possible concern for mutagenicity in humans; on the basis of in-vitro results, including results from tests conducted in mammalian cells it is considered that EP-4000S meets the criteria for classification as Germ Cell Mutagen Category 2 according to the CLP Regulation (Regulation (EC) 1272/2008).