Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
No toxic effects observed after short-term oral exposure.
Executive summary:

A preliminary trial and dose range-finding study carried out prior to the 28-day oral toxicity study in rats provides adequate information on acute oral toxicity of Ash in rats. In this study groups of 3 male and 3 female rats (altogether 24 rats) were assigned into 4 treatment groups and received Ash in 1% carboxymethyl cellulose by oral gavage at dose-levels of 0, 250, 500 or 1000 mg/kg bw /day for 7 consecutive days. The rats were observed for mortality and clinical signs, food consumption and body weight development. A functional and neurobehavioural test was carried out before dosing and on days 1 and 7. On day 8 the animals were necropsied and examined macroscopically. There was no mortality and no clinical sign in males and females dosed with the vehicle or with Ash at any dose level.

The body weight and food consumption of animals dosed with the vehicle were normal. There was no effect on body weight and food consumption of animals dosed with Ash at any dose level when compared with the vehicle group. There was no macroscopic change in animals dosed with Ash at any dose level when compared with the vehicle group.