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Administrative data

Key value for chemical safety assessment

Additional information

TEA was tested in the Ames reverse mutation assay using S. typhimurium strains TA 1535, TA 1537, TA 97, TA 98 and TA 100 at a concentration up to 10000 µg/plate with and without metabolic activation. Treatment with TEA was not associated with reverse mutations in any of the strains tested (Mortelmans, 1986). In another bacterial mutation assay using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli strains WP2 and WP2 uvrA, TEA was tested at concentrations up to 4000 µg/plate with and without metabolic activation. In this assay, TEA was not genotoxic in all the strains tested (Dean, 1985). TEA was also tested negative in a bacterial mutation study using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli strains WP2 and WP2 uvrA with and without metabolic activation at concentrations up to 2000 µg/plate (TSCATS, 1989). In a fourth mutation assay, using S. typhimurium strains TA 98 and TA 100 and E. coli strain WP2, TEA was tested at concentrations up to 20000 µg/plate with and without metabolic activation. In this assay, TEA was also tested negative (Innoue, 1982). Induction of chromosomal aberrations and sister chromatid exchanges was investigated in Chinese hamster ovary cells, exposed to concentrations up to 10100 µg/mL (which induced cytotoxicity). All tests were negative in the absence as well as the presence of metabolic activation (Galloway, 1987). TEA was also negative in the in vitro mouse lymphoma (L5178Y TK+/-) forward gene mutation assay (The Dow Chemical Company, 2010). Two independent assays at concentrations ranging from 50 to 1500 mg/ml in the absence and presence of an externally supplied metabolic activation (S9) system were performed. The highest concentration tested was the limit dose of 10 mM.

Based on the available information, IARC (2000) concluded that TEA was not mutagenic to Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 or TA 1538 in the presence or absence of exogenous metabolic activation in a number of studies. TEA did not induce mutations in Escherichia coli WP2 uvrA and WP2 try- in the presence or absence of exogenous metabolic activation in two studies. In a single study, TEA was not mutagenic to Bacillus subtilis strains carrying uvrA or uvrA and polA mutations in the presence or absence of exogenous metabolic activation. However, when TEA was mixed with sodium mitrite, mutations were induced in this system without exogenous metabolic activation; this activity was lost in the presence of exogenous metabolic activation.

TEA did not induce gene conversion in Saccharomyces cerevisiae in the presence or absence of exogenous metabolic activation in one study. In a single study, sex-linked recessive lethal mutations were not induced in Drosophila melanogaster by treatment with TEA either by diet or injection. Unscheduled DNA synthesis was not induced in rat primary hepatocytes exposed to TEA in two studies. TEA did not induce sister chromatid exchanges in Chinese hamster ovary cells in either the presence or absence of exogenous metabolic activation. Chromosomal aberrations were not induced in rat liver cells, Chinese hamster lung cells or Chinese hamster ovary cells by in-vitro exposure to TEA. It did not induce cell transformation in Syrian hamster embryo cells.


Short description of key information:
TEA did not cause gene mutations in Salmonella typhimurium and Escherichia coli (Ames test), nor were chromosomal aberrations or sister chromatid exchanges induced in Chinese hamster ovary cells. An in vitro gene mutation assay (mouse lymphoma (L5178Y TK+/-) forward gene mutation assay) was also negative. All tests were performed in the absence and presence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, TEA does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.