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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance, was tested in the chromosome aberration assay using Chinese hamster ovary (CHO) cells in both the absence and presence of an Aroclor-induced rat liver S9 metabolic activation system. The results indicate that do not induce clastogenicity in the in vitro chromosome aberration assay in CHO cells.

The test substance did not induce mutagenicty and was concluded to be negative in a Bacterial Reverse Mutation Assay.

The test substance was also evaluated for its ability to induce forward mutations at the hypoxanthineguanine phosphoribosyl transferase (HPRT) locus (hprt) of Chinese hamster ovary (CHO) cells, in the presence and absence of an exogenous metabolic activation system (S9), as assayed by colony growth in the presence of6-thioguanine (TG resistance, TG').

The results indicate that the substance was negative in the In Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT) Assay with Duplicate Cultures.


Justification for selection of genetic toxicity endpoint
Three in vitro studies were performed, (Ames test using Salmonella typhimurium), chromosome aberration using Chinese Hamster Ovary cells and an in vitro mammalian cell forward gene mutation (HPRT/CHO) assay with duplicate cultures.
All these three studies are negative and all of them are taken into consideration

Short description of key information:
The substance was considered to be negative in three in vitro mutagenicty tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008) and DSD (Directive 67/548/EEC).