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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
GLP-compliant comparable to guideline study, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Differs from current testing guidelines by using abraded skin surface.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BUTASAN, off—white powder
Purity: 99.9%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Isf:(NZW), Isaac’s Farm, Litchfield, Illinois)
- Age at study initiation: Young adult
- Weight at study initiation: 2.39—2.86 kilograms
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Animals were quarantined for at least five days.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- % coverage: 10—30% of total body surface
- Type of wrap if used: The test material was held in place by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape.


REMOVAL OF TEST SUBSTANCE
- The occlusive wrap was removed after approximately 24 hours and the excess material was wiped from the animal.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made three times during the first eight hours following test material administration and twice daily (morning and afternoon) thereafter until sacrifice, with the exception of one day when observations were only recorded once.
Body weights were recorded on days 0 (day of exposure), 7, and 14.
- Necropsy of survivors performed: yes


Statistics:
No data

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths were observed in animals of either sex.
Clinical signs:
Erytherna was observed in the exposed area of three male animals and one female rabbit on the first day after exposure.
No other clinical abnormalities were noted.
Body weight:
No effects
Gross pathology:
At necropsy, pale renal coloration was observed in one male animal, but this was not considered to be related to exposure to the test material.
No abnormalities were observed in the remaining nine rabbits.

Applicant's summary and conclusion