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EC number: 500-204-4
CAS number: 68334-05-4
Based on expert judgment, there is no evidence that Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters causes carcinogenicity.
Based on expert judgement, a testing proposal for a
carcinogenicity study within Fatty acids, C18-unsatd., dimers,
2-ethylhexyl esters would be scientifically unjustified.
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 Fatty acids, C18-unsatd., dimers,
2-ethylhexyl esters induces gene mutations in bacteria or chromosome
aberrations in mammalian cells, as the results of all genotoxicity
studies were consistently negative. Furthermore, in the available
repeated dose toxicity studies and developmental 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 the Fatty
acids, C18-unsatd., dimers, 2-ethylhexyl esters fulfills the criteria
for classification as germ cell mutagen or that they are 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. 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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