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EC number: 203-051-9
CAS number: 102-76-1
Based on expert judgment, there is no evidence that Triacetin (CAS 102-76-1) causes carcinogenicity.
Based on expert judgement, a testing proposal for a carcinogenicity
study with the substance would be scientifically unjustified. The
conclusion with regard to classification and labelling is "data lacking".
In accordance with Column 2 of Annex X, 8.9.1, of Regulation (EC) No
1907/2006, 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
germ cell mutagen category 2 or there is evidence from the repeated dose
study(ies) that the substance is able to induce hyperplasia and/or
There is no evidence that Triacetin (CAS 102-76-1) induces gene
mutations in bacteria and mammalian cells as well as chromosome
aberrations in mammalian cells, as the results of all genotoxicity
studies were consistently negative. Furthermore, in the available
repeated dose toxicity studies and reproduction/developmental toxicity
studies, no substance-related increases in the incidence of hyperplasia
or pre-neoplastic lesions were observed.
The available and relevant studies do not indicate that Triacetin (CAS
102-76-1) fulfils the criteria for classification as germ cell mutagen
or that it is able to induce hyperplasia and/or pre-neoplastic lesions.
Therefore, the conditions for a carcinogenicity study to be proposed or
required set out in Column 2 of Annex X, 8.9.1, are not met.
Furthermore, the weight of evidence from all available information leads
to the conclusion that Triacetin (CAS 102-76-1) is not carcinogenic.
Therefore, a carcinogenicity study is scientifically unjustified, will
not be proposed and shall be omitted for reasons of animal welfare in
accordance with Annex XI, 1.2, of Regulation (EC) 1907/2006.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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