Registration Dossier
Registration Dossier
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EC number: 210-959-9 | CAS number: 626-67-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro
Gene mutation in bacteria
In a bacterial reverse gene mutation assay according to GLP and OECD 471 and 472 strains TA 98, TA 100, TA 1535 and TA 1537 of S. typhimurium and E.coli WP2 uvrA were exposed to the test item (analytical purity: 80.2 %), using water as solvent, at concentrations of 25, 125, 625, 3125, 6250 µg/plate (Standard plate incubation test) and 20, 100, 500, 2500, and 5000 µg/plate (Preincubation test, 20 minutes, 37 °C) in the presence and absence of mammalian metabolic activation (liver fraction (S-9) from Aroclor 1254 induced rat) (BASF, 40M0385/964256, 1997). The test item was tested up to cytotoxic concentrations. The positive control induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background. The study is classified as acceptable (reliability 1). Despite the requirements of OECD Guideline 471 (adopted 1997), 2-Aminoanthracene was the sole positive control in the presence of S9-Mix. Cytotoxicity was observed at a concentration of > 2500 µg/plate with and without metabolic activation in the Preincubation test.
The test item was negative in the Ames test using Salmonella typhimurium strains TA98, TA100, TA 1535 and TA1537 and E.Coli WP2 uvrA with and without metabolic activation with S9 from Aroclor-induced rat liver.
Short description of key information:
in vitro
Gene mutation in bacteria
Ames test with S. typhimurium TA 98, TA 100, TA 1535, and TA 1537 as well as E.coli WP2 uvrA with and without metabolic activation: negative up to 6250 µg/plate, GLP, OECD 471 and 472, Val. 1 (BASF AG, 1997)
Endpoint Conclusion:
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data for genetic toxicity are reliable but insufficient for the purpose of classification under Directive 67/548/EEC (only Ames test available for assessment). As a result the substance is not considered to be classified for mutagenicity under Directive 67/548/EEC due to lack of data.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data for genetic toxicity are reliable but insufficient for the purpose of classification under Regulation (EC) No.1272/2008 (only Ames test available for assessment). As a result the substance is not considered to be classified for mutagenicity under Regulation (EC) No.1272/2008, as amended for the 2nd time in Commission Regulation (EU) No. 286/2011 due to lack of data.
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