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EC number: 222-048-3
CAS number: 3327-22-8
Choice of key study: the most recent
reliable study was chosen as key study. The results of the in vitro
assays were in agreement, and an in vitro unscheduled DNA study also
gave positive results. When tested in vivo, no evidence of
clastogenicity was found. The interprepation of the in vitro results is
complicated because the purity of the test substance was sometimes
questionable. The strains of bacterial cells giving positive results
when CHPTAC is tested is the same as that found when EPTAC is assayed.
Technical grade CHPTAC contains 2 -3% EPTAC as an impurity, and purified
CHPTAC converts to the more reactive epoxy (EPTAC) depending on pH: at
the typical test pH of 7.5 approximately 50% conversion of the CHPTAC
Short description of key information:
Gene mutation (Bacterial reverse mutation assay / Ames test): positive with and without activation (OECD TG 471)
Cytogenicity in mammalian cells: positive with and without activation in human lymphocytes (EEC 79/831, B10)
Gene mutation (Mammalian forward mutation CHO/HGPRT assay assay): positive with and without activation in CHO cells (similar to OECD TG 476)
In vivo: negative in mouse micronucleus assay (OECD TG 474)
The in vitro evidence for mutagenicity is not
supported by the in vivo result available. It is though that the positive
results in vitro may result from the conversion from CHPTAC to EPTAC. It is
therefore considered that non-classification is justified.
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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