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Toxicological information

Acute Toxicity: oral

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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:
1977
Report Date:
1977

Materials and methods

Test guideline
Guideline:
other: None stated in report
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test item recieved: 1st July 1977
Test material name: Distilled Lanolin fatty acids
Lot number: 1110916

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
No changes observed
Body weight:
All animals showed expected gains in bodyweight.
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.