Registration Dossier
Registration Dossier
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EC number: 946-532-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Not mutagenic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No information on the "genetic toxicity" of the Target Substance is available. However data on Similar Substance 02 has been taken into account for the assessment. More details about the substance similarity are reported in section 13.
The analogue substance was tested for gene mutation following OECD 471 and EU Method B10 (NONS dossier, 1997). For the Ames test, different strains at concentrations ranging from 10 to 5000 ug/plate were tested with and without S9 mix showing no potential for gene mutation.
Justification for classification or non-classification
Classification for mutagenicity under Regulation 1272/2008 is warranted for substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans. The classification in Category 2 is based on:
— positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
— somatic cell mutagenicity tests in vivo, in mammals; or
— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Based on the results from genetic toxicity tests the substance is not classified as mutagen.
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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