Registration Dossier
Registration Dossier
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EC number: 201-788-0 | CAS number: 87-99-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
- Principles of method if other than guideline:
- Acute oral toxicity test in the rat at 4000 mg/kg
- GLP compliance:
- no
- Test type:
- other: acute oral toxicity
Test material
- Reference substance name:
- Xylitol
- EC Number:
- 201-788-0
- EC Name:
- Xylitol
- Cas Number:
- 87-99-0
- Molecular formula:
- C5H12O5
- IUPAC Name:
- (2R,3r,4S)-pentane-1,2,3,4,5-pentol
- Details on test material:
- - Purity: not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Adult Rats: weight at study initiation: 130-175 g; Age at study initiation: not reported
- Neonatal Rats: weight at study initiation: 6 - 9 g; Age at study initiation: not more than 24 hours old
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: suspended in 5% gum acacia solution (with and without tracer dye)
- Details on oral exposure:
- DOSAGE PREPARATION: Adult rats: The compound was ground in a mortar, suspended in 5% gum acacia solution and administered orally; Neonatal rats: The compound was suspended in 5% gum acacia solution containing a tracer dye and administered orally with a 20-gauge needle.
- Doses:
- highest dose tested 4000 mg/kg
- No. of animals per sex per dose:
- 10 per dose level
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 5 days
- Frequency of observations and weighing: daily
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: none reported
- Gross pathology:
- none reported
Any other information on results incl. tables
No mortality at highest dose tested (4000 mg/kg).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 4000 mg/kg
- Executive summary:
The adult and neonatal rat oral LD50 of the test substance was determined to be greater than 4000 mg/kg/body weight.
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