Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Richtlinie 84/449/EWG, B.1 "Akute Toxizität oral"
GLP compliance:
yes (incl. certificate)
Test type:
other: acute toxicity oral
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Desoxynojirimycin, solid white powder, purity 97.2%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg with an administration volume of 10 ml/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No mortality was observed. Clinical signs included increased diuresis (in all animals), piloerection, slight sedation up to 30 minutes after application and swollen muzzle and fore paws (in single animals). Onset of symptoms was 2 hours after administration and signs had disappeared on day 5. Body weight gain was not affected. At final necropsy there were spotted white mucoid masses in the small intestine.

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity to male and female Wistar rats of Desoxynojirimycin was assessed. The test compound was formulated in tap water, the administration volume was 10 ml/kg body weight.

The LD50 of Desoxynojirimycin in male and female rats is above 5000 mg/kg.