Registration Dossier
Registration Dossier
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EC number: 406-370-3 | CAS number: 58890-25-8 MDI/CHA
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Two Ames tests and an in vivo micronucleus study are performed with the substance. In addition a mammalian cell gene mutation test with L5178Y mouse lymphoma cells and an Ames test is read across from a substance analogue. Based on the results of these studies, it is concluded that the substance is not mutagenic with or without metabolic activation. The rationale for read across of the mouse lymphoma assay and the Ames test is attached in IUCLID section 13.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames tests
The genetic toxicity of MDI/CHA was assessed using Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 strains. No increases in the numbers of revertant colonies were seen at any of the concentrations of the substance with or without metabolic activation, up to 5000 µg/plate. Based on the results it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay. The study was not conducted with E.coli and/or with S. typhimurium TA102, which have an AT base pair at the primary reversion site, as currently required.
The substance was also non-mutagenic in a study according to OECD 471 with Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and Escherichia coli strain WP2 uvrA.
In addition the Ames test with the substance analogue MDI/CHA/ODA is read-across. The genetic toxicity of the substance analogue MDI/CHA/ODA was assessed using Salmonella typhimurium TA98, TA100, TA1535 and TA1537 strains, and Escherichia coli WP2uvrA strain, in accordance with OECD 471 guideline and GLP principles. In this study the substance analogue was not mutagenic. See the read-across justification in IUCLID section 13.
In vivo micronucleus study
A micronucleus study in mice was performed with MDI/CHA, at 5000 mg/kg bw.
No increase in micronucleus formation was observed. The positive control substance cyclophosphamide led to an increase in the incidence of micronuclei.
Mouse lymphoma assay:
The mutagenic activity of the substance analogue MDI/CHA/ODA was tested in the mouse lymphoma assay conducted according to OECD 476 guideline and GLP principles.MDI/CHA/ODA was tested for 3 hours up to concentrations of 164 µg/ml in the absence and presence of S9-mix in the first experiment. In the second experiment MDI/CHA/ODA was tested for 24 hours up to concentrations of 164 µg/ml in the absence of S9-mix. No toxicity was observed and all dose levels were evaluated in the absence and presence of S9-mix in both experiments. In the absence and presence of S9-mix, MDI/CHA/ODA did not induce a significant increase in the mutation frequency. It is concluded that MDI/CHA/ODA is not mutagenic in the mouse lymphoma L5178Y test system. These results are read across to the registered substance.
See read-across justification in IUCLID section 13.
Justification for classification or non-classification
Based on the available data, MDI/CHA is not classified for genotoxicity according to Regulation (EC) No. 1272/2008 and its amendments.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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