Registration Dossier
Registration Dossier
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EC number: 221-221-0 | CAS number: 3033-77-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The most reliable study available for each endpoint was chosen. Where there was more than one reliable study, the most recent studiy was selected. The results of all the studies were in agreement.
Short description of key information:
in vitro
Gene mutation (Bacterial reverse mutation assay / Ames test): positive with and without activation in strains TA 100 and TA 1535 (OECD TG 471).
Gene mutation (gene conversion): positive in two yeast strains.
Cytogenicity in mammalian cells: positive in CHO cells.
in vivo:
Micronucleus assay in mouse (ip administration) (OECD 474): positive in males and females.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
EPTAC has been shown to be mutagenic in bacteria and in yeast, and clastogenic in vitro and in vivo causing chromosome aberrations in vivo and an increase in micronucleated PCEs in vivo. In addition, EPTAC gave a positive response in an Unscheduled DNA synthesis assay in liver cells, and a dose-related increase in sister chromatid exchanges in Chinese hamster V79 cells.
It is concluded that EPTAC is a mutagen in somatic cells in vivo. Evidence from a 28 day repeated dose study indicates that EPTAC also reaches the gonads, thus it is likely that EPTAC is also a germ cell mutagen. It is therefore considered appropriate that EPTAC should be classified as mutagen Cat 3 R48 (according to Directive 67/548/EEC); mutagen category 2 suspected of causing cancer (according to Regulation 1272/2008).
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