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EC number: 948-498-7
CAS number: 143785-33-5
The test substance is not mutagenic.
The mutagenicity of the test item was
evaluated in the Bacterial Reverse Mutation Test according to OECD
Guideline 471 and following GLP. On the basis of solubility and
precipitation tests, the initial cytotoxicity test was performed at 0.5,
0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4 and 5 μL/plate. The initial cytotoxicity
test was performed with Salmonella typhimurium TA100 both in the
presence and absence of a metabolic activation system (sodium
phenobarbitone and β-naphthoflavone induced rat liver S9 homogenate).
Treatment of tester strain TA100, with the test item in the presence and
absence of a metabolic activation system did not result in cytotoxicity.
Two independent trials were conducted by the plate incorporation method
and pre-incubation method, respectively, in the presence and absence of
a metabolic activation system. On the basis of the cytotoxicity results,
5 μL/plate was considered as the highest test concentration for the
mutation assay. In the mutation assay, the test item was tested at
concentrations of 0.05, 0.16, 0.5, 1.6 and 5 μL/plate. Vehicle control
(dimethyl sulphoxide) and appropriate positive controls
(2-nitrofluorene, sodium azide and 9 -aminoacridine, and mitomycin C for
trials “without metabolic activation” and 2 -aminoanthracene for trials
“with metabolic activation”) were tested simultaneously. The tester
strains used in the mutation assay were Salmonella typhimurium TA98,
TA100, TA 102, TA1535, and TA1537. Based on the experimental results
obtained, the mean numbers of revertant colonies at the tested
concentrations were comparable to those of the vehicle control, in both
trials, in the presence and absence of metabolic activation. There was
no appreciable increase in the number of revertant colonies at any of
the tested concentrations in both trials. The number of revertant
colonies in the positive controls resulted in a 2.3 to 14.7 fold
increase compared to the vehicle control under identical conditions.
Based on the results obtained from the study, is concluded that the test
item, is “non-mutagenic” in the Bacterial Reverse Mutation Test up to
the highest tested concentration of 5 μL/plate under the test conditions.
test substance does not have to be classified for mutagenicity according
to Regulation (EC) No 1272/2008.
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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