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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:
other: US EPA Toxic Substance Control Act (TSCA) Health Effects Test Guidelines (1982 and 1984)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US EPA Toxic Substance Control Act (TSCA) Health Effects Test Guidelines (1982 and 1984)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
From General Electric Company; Purity: >99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Ten rabbits (5/sex), weighing 2.0 to 3.0 kg and approximately 12 to 18 weeks of age were used on study.

Administration / exposure

Type of coverage:
occlusive
Details on dermal exposure:
The test substance was moistened with distilled water and applied to the dorsal surface of the clipped trunk of each rabbit. The coverage was approximately 43 mg of sample per cm2 of rabbit skin surface. A double layer of gauze sheeting was wrapped around the trunk and secured with adhesive tape. Polyethylene sheeting and bandaging tape were then wrapped around the trunk. Animals were returned to their cages. After 24 hours, all covering was removed and as much excess test material as possible was carefully removed.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex
Control animals:
no
Details on study design:
Treated rabbits were observed frequently for signs of toxic effects on the first day of the test and twice daily thereafter for 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All rabbits survived.
Clinical signs:
There were no signs of toxicity during the test.
Body weight:
All rabbits gained weight during the 14-day post-application period.
Gross pathology:
Gross pathologic evaluation revealed only a pitted surface of the kidneys of one male.
Other findings:
No local skin reactions were apparent.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 in rabbits is greater than 2000 mg/kg under the conditions of this study.