Registration Dossier
Registration Dossier
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EC number: 203-781-8 | CAS number: 110-59-8
Endpoint summary
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.
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.
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