Registration Dossier
Registration Dossier
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EC number: 947-368-7 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
in vitro Bacterial Reverse Gene Mutation Assay, OECD 471; Reliability 1 - Negative
in vitro mammalian micronucleus test using HPBL, OECD 487; Reliability 1 - Negative
in vitro gene mutation study in mammalian cells ; OECD 476; Reliability 1 - Negative
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
in vitro gene mutation study in mammalian cells ; OECD 476; Reliability 1 - Negative
The mammalian cell mutagenicity assay has two segments: the test substance is investigated with and without metabolic activation. The reason for this is that cultured cells often lack the ability to metabolize test substances, or can do so only at a reduced rate when compared to an intact organism. The addition of the metabolic activation system allows for investigation into whether the test substance can be deactivated via metabolism or whether the test substance can form
reactive metabolites that can lead to toxicity. In this instance, the results of this assay were equivocal without metabolic activation, but negative with metabolic activation. Because the addition of the metabolic activation system more closely mimics the intact animal (i.e., the intact animal is capable of metabolizing the test substance) more weight was placed on the study segment that used the metabolic activation system. The overall interpretation of this study is therefore negative.
Justification for classification or non-classification
3 in vitro assays, bacterial reverse gene mutation assay, mammalian micronucleus test using human peripheral blood lymphocytes and in vitro gene mutation study in mammalian cells (CHO), gave negative outcomes, indicating the target substance does not meet the classification criteria for mutagenicity in accordance with Regulation (EC) No 1272/2008 (CLP).
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