Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Qualifier:
according to
Guideline:
other: US CFR Title 16, Section 1500.41 and Title 49, Section 173.240
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material: 4-Methylpyridine

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped, abraded and unabraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
Six animals
Details on study design:
TEST SITE
- Area of exposure: 1 x 1 inch
- Type of wrap if used: The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure.

SCORING SYSTEM:
According to Draize, J.H. (1959) Association of the Food and Drug Officials in the U.S., Austin, Texas. The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.

Erythema and eschar formation value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation value
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3.9
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was considered irritating to skin of rabbits.