Registration Dossier
Registration Dossier
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EC number: 606-239-2 | CAS number: 19130-96-2
Acute Toxicity: oral
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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Richtlinie 84/449/EWG, B.1 "Akute Toxizität oral"
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: acute toxicity oral
- Limit test:
- yes
Test material
- Reference substance name:
- (2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol
- EC Number:
- 606-239-2
- Cas Number:
- 19130-96-2
- Molecular formula:
- C6 H13 N O4
- IUPAC Name:
- (2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol
- Details on test material:
- Desoxynojirimycin, solid white powder, purity 97.2%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system 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.
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