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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
Study period:
Not reported
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:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: a modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration.
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: 1.9-2.7 kg

No further information avaialble.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the 24 h exposure period the sleeve was removed and the skin sites gently cleansed.
Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
All animals were observed daily thereafter for 14 d for mortality, skin response and general behavior.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities observed.
Clinical signs:
All animals appeared normal through Day 14.
Body weight:
Two females that had abraded skin lost weight (0.01 and 0.25 kg) over the 14 d post-exposure period. All remaining rabbits gained weight through Day 14.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute dermal LD50 of the test substance was > 2,000 mg/kg bw.
Executive summary:

A limit test was conducted to determine the acute dermal toxicity of the test substance to albino rabbits. Three male and three female rabbits were exposed to a single dose at a level of 2,000 mg/kg bw. Prior to dosing, the trunk of each animal was clipped free of hair. Three of the animals (two male, one female) were further prepared by introducing epidermal abrasions over the clipped skin surface to enhance penetrability of the test substance through the stratum corneum. After test substance application, the trunk of each animal was encased in a sleeve of plasticized material for 24 h. Following the exposure period, the sleeve was removed and the skin sites gently cleansed. All animals were observed daily thereafter for 14 d for mortality, skin response and general behaviour. All animals survived and appeared normal through Day 14. Two females that had abraded skin lost weight over the 14 d post-exposure period. The remaining rabbits gained weight through Day 14. Under the study conditions, the acute dermal LD50 was > 2,000 mg/kg bw (Palanker, 1976).