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Key value for chemical safety assessment

Additional information

Since Amix TE (CAS 68953-70-8) is composed of at least 75 % of TEA (CAS 102-71-6) and the available data for AMIX TE are limited, a read-across to TEA was conducted. In addition to the genetic toxicity studies for TEA mentioned below, an Ames test with Amix TE was performed, using TA 1535, TA 1537, TA 98 and TA 100 at concentrations up to 5000 µg/plate with and without metabolic activation. Treatment with Amix TE was not associated with reverse mutations in any of the strains tested (BASF AG 40M0444/954218).

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, performed according to Haworth et al. (Environ Mutagen 5, Suppl 1, 3 -142). 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 in the presence of metabolic activation (Galloway, 1987). An in vitro gene mutation assay in mammalian cells in not available yet, but a HPRT test will be performed by Dow. No reliable in vivo genotoxicity study is available, but will also not be necessary providing the HPRT test will be negative.


Short description of key information:
Since Amix TE (CAS 68953-70-8) is composed of at least 75 % of TEA (CAS 102-71-6) and the available data for AMIX TE are limited, a read-across to TEA was conducted.
In addition to the genetic toxicity studies for TEA, an Ames test with Amix TE was performed, indicating no reverse mutations in any of the strains tested (BASF AG 40M0444/954218). 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. 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

Amix TE 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.