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Toxicological information

Carcinogenicity

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Description of key information

In accordance with column 2 of REACH Annex X, as TAEE is not considered mutagenic and as there is no evidence regarding hyperplasia induction and/or pre-neoplastic lesions from the subchronic repeated dose studies with the structure analogues TAME (2-methoxy-2-methylbutane) and ETBE (2-ethoxy-2-methylpropane), a carcinogenicity study is not needed for TAEE.

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

Based on the negative results of the available in vitro genotoxicity studies with TAEE and the absence of evidence regarding hyperplasia induction and/or pre-neoplastic lesions from the subchronic repeated dose studies with the structure analogues TAME and ETBE, classification is not necessary for carcinogenicity in accordance with Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.