Registration Dossier
Registration Dossier
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EC number: 701-027-7 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
No reliable carcinogenicity study is available for TAME. However TAME is not genotoxic, and the available repeated dose studies give no clear evidence that it can induce hyperplasia and/or pre-neoplastic lesions. An absence of structural alerts together with results from carcinogenicity testing for the related substance MTBE, indicate that carcinogenicity is not an endpoint of concern.
Key value for chemical safety assessment
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 is not necessary for carcinogenicity.
Additional information
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 evidence of pre-neoplastic lesions was observed in the available repeated dose studies with TAME. An absence of structural alerts together with results from carcinogenicity testing for the related substance MTBE, indicate that carcinogenicity is not an endpoint of concern.
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