Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 test of 1988 (Thompson) was performed according to OECD-/EU-testing guidelines under GLP, therefore it was identified as key study. The second test (Cordier et al., 1983) was conducted as guideline study too, but not in accordance with GLP. Therefore, the GLP test was identified as Klimisch 1 key study, whereas the non-GLP test was considered as supporting study having Klimisch 2.

Short description of key information:
Two genetic toxicity studies were performed in-vitro as reverse mutation assays (Ames Tests) and used either Salmonella typh. strains only or a combination of Salmonella typh. and E.coli strains; both tests were conducted with and without metabolic activation:
- 1st study (Thompson, 1988): not mutagenic (Salm. typh. & E.coli / GLP)
- 2nd study (Cordier et al., 1983): not mutagenic (Salm. typh. / non-GLP)
The result of the GLP-study was identified as key value for the the chemical safety assessment.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Only a Ames test test is available (gene mutation on bacteria). It is not sufficient to conclude on the classification or not of the product.

As it is an intermediate, no other studies are required for this type of dossier.