Registration Dossier
Registration Dossier
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EC number: 205-187-4 | CAS number: 135-37-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Description of key information
EDG-Na2 was considered non-mutagenic in the Salmonella typhimurium reverse mutation assay with and without metabolic activation system and negative in the HGPRT. EDG-Na2 when administered orally at 1555.2 mg /kg bw was non-mutagenic in the in vivo micronucleus test in mouse bone marrow cells.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vivo:
Results derived from the genotoxicity tests with EDG-Na2 and the structurally related substance NTA-Na3 (see also read across document in section 13) are sufficient to cover the data requirement for in vitro and in vivo mutagenicity under REACH. NTA itself does not appear to exert genotoxic effects. In certain target tissues (e.g. kidney) high NTA concentrations may form Zn-NTA, for which an aneuploidigenic effect may not be excluded. However, NTA as such is considered non-mutagenic.
Justification for selection of genetic toxicity endpoint
Well performed in vivo test
Justification for classification or non-classification
Because of all the data available on genotoxicity it is concluded that EDG-Na2 does not need classification for genetic toxicity.
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