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Administrative data

Description of key information

Repeat oral dose studies, via gavage (90 days) with rats and chronic dietary studies in rats and dogs (104 weeks), on DMH produced no adverse effects in the rat at the highest dose level tested (NOAEL = 1000 mg/kg bw/day). In a 1-year dietary repeat-dose study in the dog, signs of toxicity, decreasing bodyweight, increase in adrenal weight and mild hypertrophy in the adrenal cortex, were observed at the highest dose level tested, however these were not considered to be of an adverse nature (NOAEL = 40,000 ppm, ie, 1000 mg/kg/d, NOEL = 12,000 ppm, ie, 300 mg/kg/d). 
A repeat dose (90 day) dermal study was performed in the rat at dose concentration of 39, 130 and 390 mg/kg/day. The highest dose tested was limited by solubility. No systemic toxicity or dermal irritation was observed.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
300 mg/kg bw/day

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
390 mg/kg bw/day

Additional information

Justification for classification or non-classification

Considering that oral and dermal exposure to DMH does not produce any toxic effects no classification is required.