Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
Additional information

Two generation reproduction toxicity in CD rats - Neeper-Bradley (1994)

In conclusion, continuous exposure to DMH in the diet for two generations did not result in parental toxicity or adverse effects on reproduction or reproductive tissues at dietary concentrations as high as 20000 ppm. Small increases in parental food consumption and body weight and slight transient decreases in offspring body weight were observed at the 20000 ppm dose level. The no-observed-effect level (NOEL) for parental animals and offspring in this study was 6000 ppm. The NOEL for reproductive effects was at least 20000 ppm which was equivalent to


Short description of key information:
A two generation reproductive toxicity study is available. The substance DMH is not a reproductive toxin but there may be an effect on lactation. NOEL (reproductive effects) > 20000 ppm

Effects on developmental toxicity

Description of key information
The substance is not a developmental toxin as no maternal toxic effects and no teratogenic/embryotoxic effects were observed.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Test substance DMH was estimated of not displaying any developmental toxicity effects or teratogenic/embryotoxic effects in all three developmental studies.

Justification for classification or non-classification