Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

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.

Short description of key information:
Two Ames testa, an an MLA test and a BlueScreen HC assay are available to evaluate the genetic toxicity behavior of the test material.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test material should not be classified basing on the four available in vitro test results.