Registration Dossier

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 43 FR 37336, Part 163.81-2
Principles of method if other than guideline:
The test article was applied to the clipped and abraded skin of 5 male and 5 female albino rabbits at a dose level of 2 grams per kg bw. the animals were observed for mortality, clinical signs and body weight gain. A gross necropsy was performed of all animals sacrifieced on day 14.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
very viscous, brown, oily liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals were applied a dose of 2000 mg/kg bw
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

All animals survived the 14-day duration of the study.

One female gained body weihgt consistantly from day 0 to day 14. One male and one other female lost body weight from day 0 to day 7. The remaining 4 males and 3 females lost body weight from day 0 to day 7 and regained at least 40% of this lost body weight from day 7 to day 14.

Very slight and/or well defined erythema was observed for all animals from days 1 or 2 as late as day 11. No other dermal reactions were observed during the study.

Gross necropsy examinations revealed solitary or multiple, red or red-brown discolorations of the skin at the test sites of one male and 3 females. A diffuse, green discoloration of the lung was also observed upon necropsy examination of one ot these females. Necropsy examination of one other male revealed a solitary, tan depression on the stomach. No other abnormalities were observed upon necropsy examinations of all animals sacrificed on day 14.

Applicant's summary and conclusion

Executive summary:

The test article was applied to the clipped and abraded skin of 5 male and 5 female albino rabbits at a dose level of 2 grams per kg bw. the animals were observed for mortality, clinical signs and body weight gain. A gross necropsy was performed of all animals sacrifieced on day 14. All animals survived the 14-day duration of the study.

Therefore the LD50 is > 2000 mg(kg bw (rabbit, m+f)