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:
- supporting 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 with a dog
- 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:
- dog
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gelatin capsules
- Doses:
- 5 to 640 mg/kg
- No. of animals per sex per dose:
- one animal tested at successively higher doses
- Control animals:
- no
- Details on study design:
- Plasma glucose and cholesterol determinations were made on control samples, during dosing (1 hour after dose) and five days after final dosing. Blood counts, haemoglobin, haematocrit, BUN and blood enzymes were performed before treatment, one hour after final dosing, and five days after final dosing.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 640 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: A male dog tolerated oral ascending doses of 5 to 640 mg/kg without symptoms.
- Other findings:
- The plasma glucose was depressed after the 640 mg/kg dose but returned to normal five days later. All other aspects of the haematology and blood chemistry were normal.
Applicant's summary and conclusion
- Conclusions:
- LD50 > 640 mg/kg
- Executive summary:
A male dog tolerated oral ascending doses of 5 to 640 mg/kg without symptoms. The plasma glucose was depressed after the 640 mg/kg dose but returned to normal five days later. All other aspects of the haematology and blood chemistry were normal. The oral LD50 of the test substance in the dog was determined to be greater than 640 mg/kg/body weight.
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