Registration Dossier
Registration Dossier
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EC number: 406-690-3 | CAS number: 43136-14-7 MDI/ODA
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro genetic toxicity studies have been conducted on the test item, and one substance deemed suitable for read-across. In the bacterial reverse mutation assay (Ames test) it was concluded that the substance is not mutagenic in the presence or absence of metabolic activation. In the mammalian bone marrow chromosome aberration test, the test item was concluded to be negative for mammalian chromosome aberration and no signs of toxicity or cytotoxicity, based on the P/N ratio, were observed. In the in vitro mammalian cell transformation assay, conducted on the read-across substance N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea], it was determined that the substance is not mutagenic in the TK mutation test system.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The test item was determined to be not mutagenic in the presence or absence of metabolic activation in an Ames test. and was determined to be negative for mammalian chromosome aberration. Additionally in the mammalian bone marrow chromosome aberration test, no signs of toxicity or cytotoxicity, based on the P/N ratio, were observed.
In the in vitro mammalian cell transformation assay, conducted on the read-across substance N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea], it was determined that the substance is not mutagenic in the TK mutation test system. N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] was determined to be a worst-case structural analogue read-across source substance due to the shorter C8 chain length present. Additionally, the test item does not have a harmonised classification for genetic toxicity.
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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