Registration Dossier

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Administrative data

Description of key information

The substance is considered to be non-carcinogenic

Key value for chemical safety assessment

Justification for classification or non-classification

Classification for cancerogenicity is not warranted under 67/548/EEC or Regulation 1272/2008.

Additional information

From the existing studies no concern is arised for carcinogenic effect:

1) The substance is not mutagenic.The ability of substances to induce mutations or genotoxicity can be indicative of carcinogenic potential. There is, in general, a good correlation between positive genotoxicity findings in vivo and animal carcinogenicity bioassay results

2) Repeated dose toxicity tests: no toxicity has been revealed in repeated dose toxicity tests, no tissued has revealed preneoplastic

changes (e.g. hyperplasia or metaplasia) suspected to be conducive to tumour development

3) Toxicokinetics : no tissue has been identified as a targets for toxicity and development of tumors

4) QSAR prediction: CAESAR modelling version doesnt show any concern for carcinogenicity potential on the different conponents of the substance (Fatty acids, Fatty acids methyl esters, tryglicerides)