Registration Dossier
Registration Dossier
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EC number: 237-335-9 | CAS number: 13752-51-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Cure-rite 18 did not exhibit mutagenic activity in several assays with Salmonella and E. coli polA+. However, mutagenic effects were reported in several assays(commercial and purified) with E. coli polA-.
In the mouse lymphoma assay, positive repsonses were reported in several assays with mammalian metabolic activation.
Cure-rite 18 exhibited clastogenic activity activity in two assays using Chinese Hamster ovaries. Negative results were reported in one of those assays without mammalian metabolic acitivation. Without mammalian metabolic activation, the purified version exhibited a positive repsonse, while the commercial samples were negative.
Testing Proposal Waiver
According to the integrated testing strategy (R.7.7.6.3), testing beyond the standard set of in vitro tests is first directed towards investigating the potential for mutagenicity in somatic cells in vivo. Positive results in somatic cells in vivo consitute the trigger for consideration of investigation of potential expression of genotoxicity in germ cells. Waiving the in vivo somatic cell test (mouse micronucleus) is proposed since two in vivo germs cell studies and a carcinogenicity study have already been realised. Appropriate risk mamangement measures are in place based on the results of the carcinogenicity study. Realizing the in vivo somatic cell study would not change the risk mamangement measures in place. In three transformation assays, two positive and one negative response were reported. No effects were reported in two in-vivo dominant lethal assays.
Short description of key information:
Several genetic toxicity studies (in-vitro and in-vivo) are available giving mixed results.
Justification for classification or non-classification
Cure-rite 18 was not positive in the in-vivo dominant lethal assays.
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