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Toxicological information

Carcinogenicity

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Description of key information

No reliable carcinogenicity study is available. The substance is not expected to have genotoxic properties. In the available repeated dose studies with the read-across substance TAME, no clear evidence of pre-neoplastic lesions were observed. Lack of alert from molecule structure and results of carcinogenicity testing for the related substance MTBE, suggest that carcinogenicity is not an endpoint of concern.

Key value for chemical safety assessment

Additional information

Based on the considerations described in the document "Read-across substantiation C5-6 branched alkylmethyl-ethers” (incl. the supporting references Tuppurainen et al., 2007 and Niska et al., 2008), it can be concluded that the available information of TAME can be used to predict the carcinogenic properties of the substance ‘C5-6 branched alkylmethyl-ethers’ with sufficient certainty.

Results are available from a single oral carcinogenicity study which is considered unreliable (Belpoggi et al, 2002). The dosing regime used to treat the animals was unusual and only two dose levels were used. Moreover, the animals were allowed to live out their natural life span and no adjustment for mortality was available. The neoplasia in this study were of lymphoid origin and derived from cells originating from the bone marrow, however, results from a mouse micronucleus study with TAME, which measure the substance’s ability to induce damage in chromosomes of the bone marrow cells, was negative. The publication’s reporting was inadequate in many aspects resulting in a low level of confidence of the results. Therefore, an analysis of effective group numbers and tumour incidence were difficult to analyse.

Negative results from mutagenicity studies on TAME suggest that mutagenicity is not a contributing mode of action in the formation of tumours. In addition, no clear evidence of pre-neoplastic lesions was observed in the available repeated dose studies with TAME. Lack of alert from molecule structure and results of carcinogenicity testing for the related substance MTBE, suggest that carcinogenicity is not an endpoint of concern.

Justification for classification or non-classification

Based on the available data and in accordance with Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification of TAME is not necessary for carcinogenicity.

Based on the proposed read-across approach, this non-classification does also apply for C5-6 branched alkylmethyl-ethers.