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Diss Factsheets

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:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Similar to guideline (U.S. EPA OPP) method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
This study utilized an EPA approved guideline study format (40 CFR 789.1100).
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-vinylpyridine
EC Number:
202-879-8
EC Name:
2-vinylpyridine
Cas Number:
100-69-6
Molecular formula:
C7H7N
IUPAC Name:
2-ethenylpyridine
Details on test material:
98.7%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
Animals were individually housed in suspended stainless steel cages. Animal rooms were maintained at 68 ± 3 degrees F, relative humidity of 30-70%, with a minimum of 10-13 complete air changes per hour, and a 12 hour light-dark cycle. Animals were supplied with a commercial rabbit ration and municipal tap water ad libitum. There were no known contaminants present in the feed, water or bedding expected to interfere with the test data. Upon receipt, animals were quarantined under the same conditions as for the actual test.
The application sites were prepared by clipping the skin of the trunk free of hair approximately 24 hours prior to application of the test substance. The site of application was not abraded intentionally nor accidently during the preparation. The test substance was introduced under gauze patches and applied directly to the skin. The patches were secured in place by wrapping the entrie trunk of the animal with Vetrap impervious bandaging (3M, St. Louis, MO). At the completion of the exposure period, the wrapping was removed and the skin gently wiped and rinsed with USP water, to remove any test substance still remaining.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Substance was applied undiluted to clipped skin of the back area corresponding to about 10% of the total body surface area. At the completion of the exposure period, the wrapping was removed and the skin gently wiped and rinsed with USP water, to remove any test substance remaining. The animals were observed for signs of erythema and edema after the 24-hour exposure period.
Duration of exposure:
24 hours
Doses:
0.9, 0.65 and 0.40 g/kg body weight.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
After a 24 hour exposure, the wrappings were removed and the site was washed with water and dried. The animals were observed and weighed over a 14-day period. Skin reactions were graded according to the Draize Scale for Scoring Skin Reactions (Erythema and Eschar formation (0 to 4) and Edema formation (0 to 4). Upon sacrifice or death, necropsies were undertaken.
Statistics:
LD50 program of RJ Tallarida and RB Murray, "Litchfield and Wilcoxon II, Manual of Pharmacologic Calculations with Computer Programs, Springer-Verlag, NY, 1986, pp. 159-164.

Results and discussion

Preliminary study:
All rabbits died at the 1.0 g/kg dose level. Erythema (necrosis) and edema (scores =4) were noted on all animals on Day 1. The doses selected for the LD50 study were 0.40, 0.65, and 0.90 g/kg.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
650 mg/kg bw
Mortality:
All animals in the 0.90 g/kg dose group died within the first hour following application of the test substance. In the 0.65 g/kg dose group, 8 of 10 animals died within 3 hours following dosing.
Clinical signs:
other: Clinical signs in the 0.90 and 0.65 g/kg dose groups included cyanosis, tachypnea and asphyxial convulsions. Skin reactions scores for erythema were 2 and 3, and for edema were 1 and 2 for both dose groups
Gross pathology:
At gross necropsy, animals displayed hemorrhaging of the nictitating membrane, lung, and heart, and cyanosis of the ears.
Other findings:
In the low dose group, only skin signs were observed (Erythema of 2 and 3, and Edema of 1 and 2).

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Remarks:
Migrated information
Conclusions:
LD50 in rabbits was 0.64 g or 640 mg/kg body weight after a 24-hour occluded exposure to 2-Vinylpyridine. This corresponds to GHS Acute Dermal Toxicity Category II.