Registration Dossier
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EC number: 275-148-4 | CAS number: 71033-19-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro Gene Mutation study in Bacteria -AMES
Negative.
The test item does NOT induces reverse mutation in Salmonella typhimurium, both in the absence and presence of S9 metabolism, under the reported experimental conditions.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Studies on bacteria (AMES)
The test item was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy, according to the OECD471, in GLP.
The five tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with Phenobarbital and 5,6-Benzoflavone (Standard metabolic activation) in Main Assay I, and liver S9 fraction from uninduced hamsters (reductive metabolic activation system with Prival modification), in Main Assay II.
The test item was used as a solution in sterile water for injection and, as requested by the Sponsor, concentrations were expressed in terms of active ingredient.
Toxicity test
5000, 1580, 500, 158 and 50.0 µg/plate.
No toxicity neither increases in revertant colonies were observed with any tester strain, at any dose level, in the absence or presence of S9 metabolism.
Main Assay I
5000, 2500, 1250, 625 and 313 µg/plate.
No precipitation of the test item was observed, at the end of the incubation period, with any tester strain, at any concentration tested, in the absence or presence of S9 metabolism.
No toxicity neither increases in revertant colonies were observed with any tester strain, at any concentration tested, in the absence or
Main Assay II
Presence of reductive metabolic system (hamster S9 supplemented with flavin mononucleotide cofactory).
5000, 2500, 1250, 625 and 313 µg/plate.
No toxicity neither mutagenicity was noticed with any tester strain, at any dose level, in the absence or presence of S9 Prival metabolizing system.
The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of S9 metabolism.
Conclusion
It is concluded that the test item does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.
Justification for classification or non-classification
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.
Substance that are mutagenic in somatic cells may produce heritable effects if they, or their active metabolites, have the ability to interact with the genetic material of germ cells. Conversely, substances that do not induce mutations in somatic cell in vivo would not be expected to be germ cell mutagens.
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.
Category 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
According to the CLP Regulation n.1272/2008 and the ECHA Guidance R.7a, the substance is not classified as mutagenic.
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