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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
Study period:
January 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study accoring to internationally accepted guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Source: International Specialty Products Date Received: 01/13/97 Label Identity: Suttocide® A (Powder) Appearance: White powder Storage : The test article was stored at room temperature and humidity. Sample Preparation: The test article was weighed into aliquots and moistened at the time of dosing.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA- Quarantine period of at least one week- Body weight range was 2.0 - 2.2 kg for males and 2.0 - 2.3 kg for females- Housing: The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week. - Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet #5321) - Water (e.g. ad libitum): tap water- The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact. A single dose of the test article was applied to the prepared site at a dose level of 2000 mg/kg. The dose was based on the dry weight. The test article was applied under a 4 layered surgical gauze patch measuring 1 O X 15 cm. The patch and test article were moistened with distilled water to enhance contact of the test article with the dose site. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The torso was wrapped with plastic which was secured with non-irritating tape. The test article remained in contact with the skin for 24 hours at which time the wrappings were removed. Residual test article was removed by gentle washing with distilled water.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the 2000 mg/kg dermal application.
Clinical signs:
Instances of diarrhea and soiling of the anogenital area were noted during the observation period. Dermal reactions, well defined to moderate on day 1, were absent to severe on days 7 and 14.
Body weight:
Body weight changes were normal in 9/10 animals. One female lost weight during the first week of the study but gained normally by day 14.
Gross pathology:
Necropsy results were normal in 4/1 O animals. Treated skin abnormalities were noted in six animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The LD50 is greater than 2000 mg/kg of body weight.