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Toxicological information

Carcinogenicity

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Description of key information

Key value for chemical safety assessment

Additional information

No carcinogenicity study is available but there is information from a qualitative and quantitative understanding of the toxicological properties of the substance that a weight of evidence approach was used to decide on classification.

Proposals concerning long term repeated dose/carcinogenicity studies are set out in Illing and Barratt, (2009). Results can be 'read across', as permitted by Annex XI para 1.5, based on the justification in the reports from Paul Illing Consultancy Services Ltd and Marlin Consultancy (2007 and 2009) and on ECHA guidance. The anticipated result is that the substance is not carcinogenic. Thus, on animal welfare grounds this test should not be undertaken on 2,2',2''-nitrilotriethanol, propoxylated. For further details concerning the justification, consult Illing and Barratt, 2007 and 2009.

Justification for classification or non-classification

Although no carcinogenicity study is available, it is concluded that carcinogenicity is not an endpoint of concern. There is no evidence from the in vitro genotoxicity studies that 2,2',2''-Nitrilotriethanol, propoxylated is able to induce mutagenicity. Furthermore the available repeated dose toxicity study gives no evidence of serious or severe toxicity up to and including 1000 mg/kg (NOEAL= 1000 mg/kg) and no preneoplastic lesions were observed. Using the weight of evidence, it is concluded that carcinogenicity is not an endpoint of concern for 2,2',2''-Nitrilotriethanol, propoxylated and there is no trigger for a carcinogenicity study.