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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Three in vitro mutagenicity studies have been conducted. Two of these (an Ames test and a Mouse lymphoma TK locus assay) gave clear negative results both in the presence and absence of metabolic activation. The in vitro chromosome aberration study conducted using CHO cells, however, gave a marginally clastogenic result in the presence of metabolic activation. On the basis of this ambiguous result an in vivo mouse micronucleus study has been conducted in order to further investigate the mutagenic potential of the substance. This in vivo study, using the intraperitoneal route of exposure at dosages causing clinical signs and decreases of PCE/NCE ratio, gave a negative result thus mitigating the concern raised by the results of the in vitro chromosome aberration study. The substance is therefore considered to be non-mutagenic.


Short description of key information:
An Ames test in five strains of Salmonella typhimurium has been conducted in compliance with GLP according to OECD Guideline 471. Duplicate experiments were conducted in order to confirm the results of the study. This study was negative with and without metabolic activation.

An in vitro chromosome aberration study in CHO cells has been conducted in compliance with GLP according to OECD Guideline 473. The substance was suspiciously clastogenic in the presence of metabolic activation when tested to toxic concentrations with Chinese hamster ovary cells in vitro.

A GLP compliant in vitro mouse lymphoma assay has been conducted according to a method equivalent to OECD Guideline 476. It was concluded that the substance is not mutagenic in mouse lymphoma L5178Y cells, with and without metabolic activation, when tested at concentrations extending into the toxic range.

A GLP compliant in vivo mouse micronucleus study has been conducted in accordance with OECD Guideline 474. The test material was considered to be non-genotoxic when tested by the intraperitoneal route of exposure and causing toxic signs and decreases in the PCE/NCE ratio.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

An in vivo mouse micronucleus study gave a negative result, mitigating a concern raised by an ambiguous in vitro chromosome aberration study. There are no other reasonable grounds for concern and hence there is no need to classify the substance as mutagenic.