Registration Dossier
Registration Dossier
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EC number: 201-279-3 | CAS number: 80-43-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Dicumyl peroxide is not genotoxic/mutagenic.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Dicumyl peroxided was tested negative in the complete suite of in-vitro genotoxicity studies hence in vivo studies are not required.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity in vitro
Bacterial test systems detecting gene mutations
An Ames test was performed by MHW Japan (2000). In this guideline study according to OECD 471 using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537 or Escherichia coli WP2 uvrA strains at concentrations 0, 0, 313, 625, 1250, 2500 and 5000 µg/plate DCP was found to be negative, both with and without metabolic activation system (S9 mix).
This result is in line with several other Ames tests, all indicating that DCP did not induce gene mutations in bacteria.
Chromosome mutations in mammalian cells
A chromosome aberration study in Chinese hamster lung (CHL) cells was carried out by MHW Japan (2000). This assay was conducted both with and without metabolic activation system (S9 mix) at 6 dose levels from 20 to 225 µg/mL. Toxicity was observed at the high dose tested in each treatment condition (with and without S9 mix).
Under the conditions of the assay, DCP did not induce structural or numerical chromosome aberrations in CHL cells when tested both in the presence as well as in the absence of an exogenous metabolic activation system. DCP was concluded to be negative in the CHO chromosome aberrations assay.
Gene mutations in mammalian cells
Effects of dicumyl peroxide on gene mutation in mammalian cells were investigated in a study according to OECD guideline 476. Chinese hamster lung fibroblasts were exposed with and without metabolic activation system (S9 mix). No increase in gene mutation at the HPRT locus was observed when tested up to 156.3 µg/mL with and up to 39.1 µg/mL without S9 mix.
Genetic toxicity in vivo
Further testing on genotoxicity in vivo is not considered necessary based on the negative outcome of the tests performed in vitro.
Justification for classification or non-classification
Based on the results of reliable studies classification for genotoxicity is not warranted according to EU regulation 1272/2008.
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