Registration Dossier
Registration Dossier
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EC number: 275-118-0 | CAS number: 71010-76-9
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
For Tetra-esterification products of nC5, C7, C8, C10 fatty acids with pentaerythritol there are no data available for carcinogenicity. According to the REACH regulation (1907/2006/EC), a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and the substance is classified as mutagen category 2 or there is evidence from repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions. There is no evidence that the registered substance, Tetra-esterification products of nC5, C7, C8, C10 fatty acids with pentaerythritol, causes carcinogenicity by a direct genotoxic mechanism. The results of all genotoxicity studies (mutagenicity and cytogenicity) were negative. In the 28-day repeated dose toxicity study no evidence for hyperplasia or preneoplastic lesions was seen. Thus, based on the lack of mutagenicity classification and the lack of hyperplastic responses in a repeat dose study, a carcinogenicity study would be scientifically unjustified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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