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EC number: 251-090-5
CAS number: 32539-83-6
Data from an Ames study completed in 2000
(point 7.6.1 in the template) suggests that the test material may cause
gene mutations in bacteria via a direct acting mechanism (positive
without metabolic activation, negative with metabolic activation). The
absence of a mutagenic response in the presence of metabolic activation
may be taken to indicate that mammalian enzymes are capable of
inactivating the mutagenic activity seen in the absence of S9. To verify
the result of the Ames test, and in line with the Intelligent Testing
Strategy proposed by the European Authorities in the Guidance on
information requirements and chemical safety assessment, a Mouse
Lymphoma study (MLA) was performed (point 7.6.1 in the Template). The
results of the MLA do not support that the test material is a gene
mutagen (no significant increase in large colonies), furthermore, the
test material was considered not to be a clastogen in this assay (no
significant increase in small colonies). A third in vitro test was
performed, a BlueScreen HC Assay. This is a mammalian cell assay using
human TK6 cells and detects a wide range of genotoxic events including
clastogenicity,point mutations and aneuploidy. This assay gave a clear
negative response both in the absence and presence of metabolic
activation. In addition, a second Ames test has been peformed (2012) and
in this case the substance was shown to be non-mutagenic, thereby
contradicting the result of the previous study. The cause for the
discrepant results is not known but the explanation may be either a
different impurity profile in the two batches tested or that the first
study was technically flawed and gave a false positive result.
When these study data are taken as a whole then, on a weight of evidence
basis, the substance is considered to be non-genotoxic.
The test material should not be classified basing on the four available
in vitro test results.
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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