Registration Dossier
Registration Dossier
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EC number: 701-347-7 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Non mutagenic with and without metabolic activation (in vitro gene mutation in bacterial cells).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No study available
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity in vitro
The study procedures described in this report were based on the most recent Guideline OECD 471 (2020) and EU Method B.13/14 (2008) and under GLP conditions.
The test item was tested in the Bacterial reverse mutation assay with five strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537).
The test was performed in four experiments in the presence and absence of metabolic activation, with +S9 standing for the presence of a metabolic activation, and -S9 standing for absence of metabolic activation.
The experiment 1 had to be repeated for TA98, TA100, TA1535 and TA1537 due to toxic effects and therefore an insufficient number of analyzable non-toxic concentrations as indicated in the guideline. Experiment 1b was invalid for TA1535 because of probable contamination and was therefore repeated in exp. 1c.
Results highlighted that no adverse effect (mutations) was induced by the test substance.
The substance is considered to be non mutagenic in the bacterial cells with and without metabolic activation
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two following categories:
- substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans or
- substances, which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.
The test substance did not show any reasons of concern in the in vitro test performed.
Therefore, the substance is not classified for genetic toxicity according to the CLP Regulation (EC) No. 1272/2008.
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