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EC number: 203-733-6
CAS number: 110-05-4
While no carcinogenicity study per se is available, a number of
investigations have been conducted over the years to determine the
initiation/promotion activity of di-tert-butyl peroxide (DTBP). Taken
together, DTBP was inactive as an initiator or promotor. See Specific
Investigations section 7.9.3 of IUCLID. In addition, DTBP is not
mutagenic in vitro. While DTBP was weakly positive in an in vivo IP
micronucleus study (not a relevant route of exposure) and equivocal in
an in vivo oral micronucleus study, it was negative in an in vivo
micronucleus assay by inhalation, which is the most likely route of
exposure and negative in a spermatogonal assay. Therefore, DTBP is not
expected to be carcinogenic based on a weight of evidence. We are
trying to work with the NL or BE Competent Authorities to remove the
mutagenicity classification of 110-05-4 and 75-91-2 based on new in vivo
studies, however, they wish to await the carcinogenicity study results
of 75-91-2 (which was unfortunately required via testing decision prior
to new definitive negative in vivo mutagenicity results) before
assessing possible new CLH dossiers to remove mutagenicity.
Furthermore, there is a draft decision (SEV-D-2114360151-63-01/D) for
carcinogenicity study testing on 110-05-4 which has been challenged and
awaiting further feedback from the authorities.
No carcinogenicity study is available.
However, based on a weight of evidence, the registered substance is not
expected to be carcinogenic.
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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