Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.