Registration Dossier
Registration Dossier
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EC number: 270-315-8 | CAS number: 68424-66-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 February 1974 to 15 March 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Lanolin, hydroxylated
- EC Number:
- 270-315-8
- EC Name:
- Lanolin, hydroxylated
- Cas Number:
- 68424-66-8
- IUPAC Name:
- Lanolin, hydroxylated
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: 24 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
IN-LIFE DATES: From: 28 February 1974 To: 13 March1974
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION (if unusual): Test material warmed to body temperature prior to dosing. Test material was supplied as a paste.
- Doses:
- 2.5, 5.0, 10.0, 20.0, and 40.0 mL/kg
- No. of animals per sex per dose:
- 1/sex/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths in any of the dose groups
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 of the test material was determined to be >10.0 mL/kg.
- Executive summary:
The test material was administered by oral gavage to rats of the Sherman-Wistar strain, 1/sex/dose group, was not lethal at doses of 40.0 mL/kg and lower. Since 8 out of 8 rats receiving doses between 5.0 and 40.0 mL/kg survived the study authors determined with 95% accuracy that the LD50 would be in excess of 10.0 mL/kg.
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