Registration Dossier

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: Non-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methylbutinol

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
48 hours.
Observation period:
4, 24 and 48 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1.5 x 1.5 inch
- % coverage: 100
- Type of wrap if used: Ply gauze squares with entire trunks of the animals wrapped in clear plastic trunk bands

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with appropriate solvent
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
intact skin
Time point:
other: 4, 24 and 48 hours
Score:
0.8
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
other: 4, 24 and 48 hours
Score:
0.4
Max. score:
2
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
other: 4, 24 and 48 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
Erythema-eschar observation Edema observation
RABBIT# SKIN 4 h 24 h 48 h 4 h 24 h 48 h
1 Intact 2 1 0 0 0 0
Abraded 2 1 0 0 0 0
2 Intact 1 0 0 0 0 0
Abraded 2 1 0 0 0 0
3 Intact 2 1 0 0 0 0
Abraded 2 2 1 0 0 0
4 Intact 2 1 0 0 0 0
Abraded 2 2 1 0 0 0
5 Intact 1 0 0 0 0 0
Abraded 2 1 0 0 0 0
6 Intact 2 1 1 0 0 0
Abraded 2 2 1 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained the test substance was considered non irritating.
Executive summary:

A dermal skin irritation/corrosion study was carried out according to a method similar or equivalent to EU method B.4 and OECD guideline 404. Skin of 6 Albino rabbits was exposed to 0.5 ml undiluted test item. The hair was clipped from the backs with the aid of angora clippers. Four areas of the back, placed approximately ten centimeters apart, were designated for the positions of the patches. Areas 2 and 3 were abraded by making four epidermal incisions (two perpendicular to two others in the area of the patch). The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape. The material to be tested was introduced beneath the patch. The entire trunks of the animals/were then wrapped in clear plastic trunk bands. The trunk bands help to hold the patches in position and retard evaporation of volatile substances during the four hour exposure period. Upon removal of the patches the resulting reactions were evaluated on the basis of weighted scores.

Following the initial reading, all test sites were washed with appropriate solvent to prevent further exposure. Readings were again made at 24 and 48 hours after the initial application.

The primary irritation index was calculated by adding all values for erythema or eschar formation, and edema at 4, 24 and 48 hours on intact skin and dividing the number of readings. In addition, mean values for erythema or eschar formation at 4, 24 and 48 hours on intact skin were calculated.