Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
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:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups rabbits of either sex were used. A single application of the test material was made at different dose levels. The material was applied to the closely clipped abdominal skin. The test material was moistened with corn oil and spread evenly on a non-absorbent paper backing which was then applied to the skin. The trunks of the animals were wrapped securely with gauze and adhesive tape. After an exposure period of 24 hours, the binders were removed and the area of exposure was washed. The animals were observed for toxic effects and mortality. Throughout the observation period the rabbits were individually housed in elevated metal cages and food and water were freely available at all times. At the end of the observation period each animal was weighed, sacrificed, and examined grossly.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: Individually in elevated metal cages
- Diet (e.g. ad libitum): Ad libitum (Purina Rabbit Chow)
- Water (e.g. ad libitum): Ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: Abdomen
- Type of wrap if used: Gauze and adhesive tape
- The areas of exposure of two animals at each level were abraded and the other two remained intact.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sponged with warm tap water to remove any sample residue
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: no
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): Enough to moisten the test substance
Duration of exposure:
24 h
Doses:
100, 316, 1000, and 3160 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 4, 24 h, and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 3 160 mg/kg bw
Mortality:
None
Clinical signs:
Normal appearance and behavior
Body weight:
Normal
Gross pathology:
None
Other findings:
Following the removal of the binders at the endo of the exposure period, most or all of the material was still present on the abdomen and the binders of all animals. At the end of the 24h-exposure period, slight erythema was seen in all animals; however, this dermal response completely subsided between the second and the fifth day. For three to seven days during the observation period, slight desquamation was noted on the area of exposure of two animals (one at each level). At termination, there were no signs of dermal irritation in any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 for albino rabbits is greater than 3160 mg/kg of body weight and there was no evidence of systemic toxicity from percutaneous absorption of the test material.