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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets gereally accepted criteria, but individual data are not shown
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Principles of method if other than guideline:
Groups of 4 albino rabbits were evaluated for acute dermal toxicity following single dermal application for 24 hours and a post exposure observation period of 7 days; gross autopsy
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
the test substance was considered of 100 "% purity

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2.5 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
the material was moistened with water to form a paste; the paste was spread evenly on a non-absorbent paper backing which was applied to the closely clipped intact abdominal skin. The trunks were then wrapped securely with a gauze and adhesive tape binder for 24 hours. After removal of the binder the skin was rinsed with water in order to remove any residues. The animals were observed for 7 days
Duration of exposure:
24 hours
Doses:
1000, 2150, 4640, 10000 mg/kg bw
No. of animals per sex per dose:
4 per dose
Control animals:
not specified
Details on study design:
the material was moistened with water fo form a paste; the paste was spread evenly on a non-absorbent paper backing which was applied to the closely clipped intact abdominal skin. The trunks were then wrapped securely with a gauze and adhesive tape binder for 24 hours . After removal of the binder the skin was rinsed with water in order to remove any residues. The animals were observed for 7 days
Statistics:
no data all aninals survived

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
other: no mortality occurred
Remarks on result:
other: no mortality
Mortality:
no
Clinical signs:
a very mild degree of dermal irritation which disappeared at the next day, no other signs were observed
Body weight:
increase over the initial body weight ( no further details given)
Gross pathology:
1000 mg/kg bw: no findings
2150, 4640, 10000 mg/kg bw::
the kidneys of the majority of the rabbits contained hyperemic zone at the cortico-medullary junction , no other findings
Other findings:
no data

Applicant's summary and conclusion

Executive summary:

Groups of 4 albino rabbits were evaluated for acute dermal toxicity followling single dermal application

of 1000, 2150, 4640, 10000 mg/kg bw as paste for 24 hours and a post exposure observation period of

7 days. A very mild degree of dermal irritation which disappeared at the next day was the only clinical finding;

no animal died. Gross autopsy showed histopathological changes only in the kidneys from 2150 mg/kg bw

onwards. In the absence of any deaths, the LD50 value after single dermal administration is >10000 mg/kg bw (Celanese Corporation 1956).