Registration Dossier
Registration Dossier
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EC number: 945-131-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Non genotoxic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No studies on the "Genetic Toxicity in vitro" are available for the substance in itself.
Nevertheless a study was conducted with an analogue molecule (Similar Substance 03). Further information are reported in the Read Across justification attached to section 13.
The study was performed according to the guideline OECD 471 and EU Method B.13/14.
The test was performed in two independent experiments both with and without the addition of rat-liver post mitochondrial supernatant (S9 fraction) as an extrinsic metabolic activation system. ln both mutagenicity tests normal background growth was observed with all strains at all concentrations.
Justification for classification or non-classification
GERM CELL MUTAGENICITY
This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.
Category 1: Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans.
Categoty 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.
Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests as In vitro mutagenicity tests such as these indicated in 3.5.2.3.8:
- in vitro mammalian chromosome aberration test;
- in vitro mammalian cell gene mutation test;
- bacterial reverse mutation tests
The substance did not create gene mutations in the strains of Salmonella typhimurium and E. Coli under the performed test, therefore according to the 3.5. of the CLP Regulation EC n.1272/2008, it cannot be classified as mutagenic for germ cells.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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