Registration Dossier
Registration Dossier
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EC number: 476-160-4 | CAS number: 54807-34-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A daily application of 25 microL of the appropriate concentration of NaDMH to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3) did not elicit a sensitisation response therefore it can be concluded that NaDMH is not a skin sensitiser. Exposure of the mice to the positive control, Alpha-Hexylcinnamaldehyde, resulted in a 85% response and was therefore considered to be a sensitiser under the conditions of the test.
Additionally 75 % DMH w/v in mineral oil did not elicit a sensitisation response in the assay therefore it can be concluded that DMH is not a skin sensitizer. Exposure of guinea pigs to the positive control (DNCB) resulted in a significant delayed contact hypersensitivity response in 100% of the DNCB induced animals. This response demonstrates that the test system is capable of detecting potential sensitizers.
Migrated from Short description of key information:
A local lymph node assay in the mouse is available for the chemical NaDMH. Additionally a Delayed Contact Hypersensitivity Study in Guinea Pig is also available for the analogue chemical DMH.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
NaDMH did not elicit a sensitisation response therefore it can be concluded that NaDMH is not a skin sensitiser.
Test substance is not classified.
DMH did not elicit a sensitisation response in the assay therefore it can be concluded that DMH is not a skin sensitizer.
As previously stated the Guinea Pig study has been performed on DMH (Dimethyl Hydantoin) and has been used for read-across purposes. A summary of data for read-across of NaDMH with DMH is given in Section 13.
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