Registration Dossier
Registration Dossier
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EC number: 270-302-7 | CAS number: 68424-43-1
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:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Guideline:
- other: None stated in report
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Lanolin fatty acids
- IUPAC Name:
- Lanolin fatty acids
- Details on test material:
- Test item recieved: 1st July 1977
Test material name: Distilled Lanolin fatty acids
Lot number: 1110916
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not stated in report
- Age at study initiation: not stated in report
- Weight at study initiation: 150 - 300g
- Fasting period before study: fasted overnight prior to administration of the test material.
- Housing: not stated in report
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 7 days
ENVIRONMENTAL CONDITIONS
Not stated in report
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5 g/kg/bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage. Observations were made daily thereafter to a total of fourteen days.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg/bw
- Based on:
- test mat.
- Mortality:
- All animals survived the study
- Clinical signs:
- other: No changes observed
- Gross pathology:
- No change observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material has been determined to have an LD50 > 5 g/kg/bw.
- Executive summary:
Albino rats in groups of ten (5M:5F), weighing between 150 and 300 g, were dosed once using an oral method, and observed for fourteen days. The LD50 of the test material has been determined to be greater than 5 g/kg/bw.
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