Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The major constituent, TEA was tested in the 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). 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.

The constituent DEA formulated in ethanol did not induce micronuclei in vivo in peripheral blood erythrocytes of mice after repeated unoccluded dermal application for 13 weeks at doses clearly showing systemic availability.

DEA did not induce reverse mutations in Salmonella typhimurium or Escherichia coli.

In mammalian in vitro systems, DEA did not induce chromosomal aberrations in rat hepatocytes, sister chromatid exchange or chromosomal aberrations in Chinese hamster ovary cells and gene mutation in mouse lymphoma cells.

DEA formulated in ethanol did not induce micronuclei in vivo in peripheral blood erythrocytes of mice after repeated unoccluded dermal application for 13 weeks at doses clearly showing systemic availability.

Short description of key information:

The major constituent, TEA, did not cause gene mutations in Salmonella typhimurium (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.

The constituent DEA did not induce reverse mutations in Salmonella typhimurium or Escherichia coli. In mammalian in vitro systems, DEA did not induce chromosomal aberrations in rat hepatocytes, sister chromatid exchange or chromosomal aberrations in Chinese hamster ovary cells and gene mutation in mouse lymphoma cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data from the major constituent TEA, and one of the other constituents, DEA, the substance 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.