Registration Dossier

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.