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
In vitro studies
EPTAC causes mutations in E. coli WP2 and S. typhimurium 1535, 1537 and 100 but not in 1538 or 98. These mutations did not require metabolic activation to occur. The evidence from the bacterial mutagenicity tests suggests that EPTAC acts as a direct point mutagen by base pair substitution but not frame shift mutation. In addition, tests in two yeast strains have demonstrated that EPTAC can cause gene conversion in two different gene loci.
The positive response in the liver UDS test gives indications of increased DNA damage in mammalian cells as well.
In addition, a well-correlated dose-related increase of sister chromatid exchanges in the Chinese hamster V79 cells was seen.
Damage to chromosomes has been shown to occur in mammalian test systems in vitro. The results of the in vitro chromosome aberration tests in both rat liver cells and Hamster ovary cells showed that both the frequency of aberrations per cell, with or without gaps, and the percentage of cells with all aberrations increased with the dose.
Positive in vitro results show that in addition to causing point mutations in bacterial systems, EPTAC has clastogenic or aneugenic potential in mammalian cells as well.
In vivo study
In an in vivo chromosome aberration test performed according to OECD guideline No 474 and in compliance with GLP, mice (BOR:NMRI) were exposed by intraperitoneal injection to EPTAC at a concentration of 82.5 mg/kg.Positive controls induced the appropriate response.
There was a clear statistically significant increase of micronucleated PCE in males and females.
Under the test conditions, EPATC is clastogenic in mouse in vivo.
Short description of key information:
Positive results in vitro show that in addition to causing point mutations in bacterial systems, EPTAC has clastogenic or aneugenic potential in
mammalian cells as well.
In an in vivo chromosome aberration test in the mouse, EPATC is clastogenic under these conditions .
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
Harmonised classification
EPTAC is classified as Muta. 2 (H341: Suspected of causing genetic defects) according to the CLP Regulation (EC) N° 1272/2008 and as Muta. Cat. 3 (R68 Possible risk of irreversible effects) according to the Directive 67/548/EEC.
No additional self-classification is proposed.
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