Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with U.S. Department of Transportation guidelines. There is no information on whether GLP was utilized. This study does not provide information on the purity of the test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: U.S. 49 CFR 173.240
Principles of method if other than guideline:
This is the established guideline for U.S. Department of Transportation classification of corrosive materials.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylpyridine
EC Number:
203-643-7
EC Name:
2-methylpyridine
Cas Number:
109-06-8
Molecular formula:
C6H7N
IUPAC Name:
2-methylpyridine
Constituent 2
Reference substance name:
alpha-picoline
IUPAC Name:
alpha-picoline
Details on test material:
Lot # 30330
No further information on purity.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The animals were housed and maintained in accordance with standards set forth in the Guide for the Care of Laboratory Animals (U.S. DHEW Publication No. 80-23).
Husbandry Conditions:
Temperature: 60-75 degrees F.
Relative humidity: 40-45%
Light: 12 hour light/dark cycle
Diet: Wayne 15% rabbit ration and tap water were provided ad libitum
Caging: Stainless steel with elevated wire mesh flooring, 1 rabbit/cage.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Sample was applied as undiluted liquid material.
Duration of treatment / exposure:
4 hours
Observation period:
4 hours (immediately after sample was removed), 24 and 48 hours after initiation of contact.
Number of animals:
6
Details on study design:
A 0.5 ml portion of the material was applied to the clipped skin, covering an area of approximately 1 square inch. Surgical gauze patches measuring not less than 1 inch x 1 inch were placed over the treated area and an impervious material was wrapped snugly around the trunk of the animal. The wrappings were removed at the end of a 4 hour period contact period and the treated site was examined. The site was then washed off with water to avoid continued exposure to the material. Readings were also made after 24 and 48 hours.
Method of Evaluation:
Corrosion was considered to have resulted if the material had caused destruction or irreversible alteration of the tissue. Tissue destruction was considered to have occurred if, at any of the readings, there was ulceration or necrosis. Tissue destruction was not considered to have occurred if merely sloughing of the epidermis, erythema, edema or fissuring was evident.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Occurrence of ulceration or necrosis
Basis:
animal #1
Time point:
other: 4 h
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: Corrosive at 4, 24 and 48 h.
Irritation parameter:
other: Occurrence of ulceration or necrosis
Basis:
animal #2
Time point:
other: 4 h
Reversibility:
not fully reversible within: 48 h.
Remarks on result:
other: Corrosive at 4, 24 and 48 h.
Irritation parameter:
other: Occurrence of ulceration or necrosis
Basis:
animal #3
Time point:
other: 4 h
Reversibility:
not fully reversible within: 48 h.
Remarks on result:
other: Corrosive at 4, 24 and 48 h.
Irritation parameter:
other: Occurrence of ulceration or necrosis
Basis:
animal #4
Time point:
other: 4 h
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: Corrosive at 4, 24 and 48 h.
Irritation parameter:
other: Occurrence of ulceration or necrosis
Basis:
animal #5
Time point:
other: 4 h
Reversibility:
not fully reversible within: 48
Remarks on result:
other: Corrosive at 4, 24 and 48 h.
Irritation parameter:
other: Occurrence of ulceration or necrosis
Basis:
animal #6
Time point:
other: 4 h
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: Corrosive at 4, 24 and 48 h.
Irritant / corrosive response data:
All animals displayed corrosivity of the skin after a 4 h exposure to undiluted alpha-picoline, which did not resolve at 24 or 48 h after dosing.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: U.S. 49 CFR 173.240
Conclusions:
Alpha-picoline is corrosive to the skin of rabbits after a 4 h exposure, not resolving at 24 or 48 h after dosing. Corrosion was defined as destruction (ulceration or necrosis) or irreversible alteration of the tissue.