Registration Dossier
Registration Dossier
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EC number: 938-702-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In Vitro Bacterial Reverse Mutation Assay: Cyclohexanol, 4 -C11 -12 -alkyl, branched was tested for mutagenic activity in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and in Escherichia coli WP2 uvrA according to OECD guideline 471, European Commision Annex V Test Method B13 and B14 and EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998).
Two independent tests were conducted in triplicate in the absence and presence of a metabolic activator (S9 mix). The first test was conducted by the direct plate incorporation method, while the second test was conducted by the pre-incubation method. The test item was dosed at concentrations ranging from 31.6 to 5000 µg/plate in both assays. No evidence of mutagenic activity was obtained with any strain in either test.
It was concluded that Cyclohexanol, 4 -C11 -12 -alkyl, branched was not mutagenic in strains of Salmonella typhimurium and Escherichia coli when tested in DMSO in the absence and presence of metabolic activation. The test item was tested to the predetermined maximum of 5000 µg per plate, no toxicity was observed. In addition, the test item was tested up to and beyond its limits of solubility in the test system.
On the basis of available in vitro data no genotoxic potential has been identified for Cyclohexanol, 4 -C11 -12 -alkyl, branched.
Short description of key information:
In a reliable (Klimisch 1) GLP compliant bacterial reverse mutation assay conducted according to OECD 471 guidelines, Cyclohexanol, 4-C11-12-alkyl, branched were reported to be negative for mutagenic activity.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The negative result reported in an in vitro genotoxicity assay do not warrant the classification of Cyclohexanol, 4 -C11 -12 -alkyl, branched as a substance with genotoxic potential. Consequently Cyclohexanol, 4 -C11 -12 -alkyl, branched is not classified as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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