Registration Dossier
Registration Dossier
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EC number: 954-598-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Non mutagenic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One test is available on similar substance 1.
The test substance was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The test was performed according to the EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, corresponding to the OECD Guideline 471.
Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used. The test substance was diluted in water for injection and assayed in doses of 100 - 2300 mg per plate, which were applied to plates in volume of 0.1 mL.
Experiments were performed without as well as with metabolic activation with a supernatant of rat liver and a mixture of cofactors. The first experiments were performed without and the second experiments with 30 minutes of pre-incubation at 37 ± 1 °C and shaking.
In the arrangement given above, the test substance, was non-mutagenic for all the used tester strains without as well as with metabolic activation. Pre-incubation had no influence on study results.
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 test conditions, therefore according to the 3.5. of the CLP Regulation EC n.1272/2008, it cannot be classified as mutagenic for germ cells.
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