Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 30 October 1986 and 13 November 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 40 CFR, Section 163.81-2, Federal Register, August 22, 1978
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Test Article : OS# 68022B
Description : Dark brown liquid
Test Article Received : 10/13/86

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
The New Zealand White rabbit, weighing 2.0 to 3.0 kg, was used for this study. The animals were obtained from Buckshire, Corp., Perkasie PA 18944 (U.S.D.A. License (#23-BL).
The animals were individually housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW Publication No. 80-23). The rabbits were acclimated to the laboratory for at least 5 days prior to dosing.
The animals were individually identified by an ear tag and each cage was identified with a cage card.
Husbandry Conditions:
Relative Humidity,%: 55 ± 25
Temperature: 60°F - 75°F
Light: 12 hour light/dark cycle
Diet: Wayne 15% Rabbit Ration and tap water were provided ad libitum. Based on our current knowledge, no contaminants are known to be in this diet or water which might be expected to interfere with the objectives of the study.
Caging: Stainless steel with elevated wire mesh flooring, 1 rabbit/cage.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The Test Article was dosed as supplied, at a dose level of 4.0 g/kg.
Duration of exposure:
24 hours
Doses:
4.0 gm /kg body weight
No. of animals per sex per dose:
5 male
5 female
Control animals:
not required
Details on study design:
The test article was dosed as supplied at a dose level of 4.0 g/kg.
A group of 10 rabbits (5 male & 5 female) with healthy intact skin was used. Approximately 24 hours before testing the fur was clipped from the backs of the test animals.
All rabbits were weighed and the correct amount of Test Article was applied to approximately 10% of the body surface on each animal. The treated area was covered with a large porous gauze patch and wrapped with an impervious material to ensure that the animal did not ingest the Test Article. The dressings were removed after 24 hours and any excess material removed, where practical, using water or an appropriate solvent.
The animals were observed for a 14 day period for signs of toxicity (systemic and topical) and for mortalities. Animals were observed frequently during the first day of dosing, and twice per day (morning and afternoon) on weekdays. On weekends and holidays, animals were observed once per day. Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. The animals were euthanized using T-61 at the conclusion of the observation period. Gross necropsies were performed on all animals.



Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 95% confidence limits not reported.
Mortality:
See Table 1 (attachment 1) for individual mortality data
One female animal died during the study


Clinical signs:
See Table 2 (attachment 2) for Observations data
Body weight:
See Table 1-(attachment 1) for average bodyweight data
Gross pathology:
See Table 2 (attachment 2) for Pathology data
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
other: acute dermal LD50 greater than 4.0 g/kg.
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
The Test Article when dosed as supplied and studied in 5 male and 5 female albino rabbits, appears to have an acute dermal LD50 greater than 4.0 g/kg.
Executive summary:
Introduction: To determine the acute dermal toxicity of the Test Article in rabbits. Method: The Test Article was dosed as supplied, at a dose level of 4.0 g/kg. A group of 10 rabbits (5 male & 5 female) with healthy intact skin was used. The animals were observed for a 14 day period for signs of toxicity (systemic and topical) and for mortalities. Conclusion: Test Article when dosed as supplied appears to have an acute dermal LD50 greater than 4.0 g/kg.