Registration Dossier
Registration Dossier
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EC number: 271-692-1 | CAS number: 68604-41-1 The complex residuum from the distillation of the methyl ester of C16-18 and C18-unsatd. fatty acids. It consists primarily of trialkyl glycerides and undistilled methyl ester of the fatty acids.
Carcinogenicity
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 1.0.0.6 doesnt show any concern for carcinogenicity potential on the different conponents of the substance (Fatty acids, Fatty acids methyl esters, tryglicerides)
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