Registration Dossier

Administrative data

Description of key information

An acute oral study has been performed on NaDMH. 
An acute oral and dermal study have been performed on the analogue substance DMH.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
20 000 mg/kg bw

Additional information

A dermal study was not carried out on NaDMH instead a read-across study from the analogue substance DMH has been included in this registration. The classification for DMH is as follows: DMH is not classified by the oral or dermal route as DMH has a LD50 > 5000 mg/kg by the oral route and a LD50 > 20000 mg/kg by the dermal route.

Justification for classification or non-classification

NaDMH is not classified by the oral route as the LD50 > 2500 mg/kg.

A dermal study was not carried out on NaDMH instead a read-across study from the analogue substance DMH has been included in this registration. The classification for DMH is as follows: DMH is not classified by the oral or dermal route as DMH has a LD50 > 5000 mg/kg by the oral route and a LD50 > 20000 mg/kg by the dermal route.

The conclusion is that NaDMH is not classified by the oral or dermal route as the LD50 is considered to be > 2500 mg/kg for both routes.

As previously stated an acute oral and dermal study have been performed on DMH (Dimethyl Hydantoin) and have been used for read-across purposes. A summary of data for read-across of NaDMH with DMH is given in Section 13.