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Toxicological information

Skin irritation / corrosion

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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
poorly documented
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-allylveratrole
EC Number:
202-223-0
EC Name:
4-allylveratrole
Cas Number:
93-15-2
Molecular formula:
C11H14O2
IUPAC Name:
4-allyl-1,2-dimethoxybenzene
Test material form:
liquid
Specific details on test material used for the study:
Purity of each material was checked in the Organic Chemicals Synthesis Laboratory, AEQI, in Beltsville by gas chromatography: > 98%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9-3.1 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
The hair was clipped from the back and flanks of each of 6 rabbits, and two sites located lateral to the midline of the back and approximately 10 cm apart were selected for the test; one site was abraded by making four epidermal incisions, two perpendicular to the other two. A 0.5-ml dose of undiluted test material was applied to each site. The sites were immediately covered with 2-in.-square gauze patches that were secured with masking tape, and the trunk of each animal was wrapped with plastic sheeting to maintain the patches in position and retard evaporation of the test material. After 24 h the plastic wrappings and gauze patches were removed, and the intact and abraded test sites were scored separately for erythema and edema on a graded scale of 0 to 4; after 72 h, the sites were scored again. The mean primary irritation score (maxi- mum = 8) represents an average of the 24- and 72-h ratings of the intact and abraded sites.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Irritant / corrosive response data:
The substance was determined to be non irritant since the primary irritation score was lower than 5.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was determined to be non irritating to the skin.
Executive summary:

A primary skin irritation test was performed in Albino rabbits. The hair was clipped from the back and flanks of each of 6 rabbits, and two sites located lateral to the midline of the back and approximately 10 cm apart were selected for the test; one site was abraded by making four epidermal incisions, two perpendicular to the other two. A 0.5-ml dose of undiluted test material was applied to each site. The sites were immediately covered with 2-in.-square gauze patches that were secured with masking tape, and the trunk of each animal was wrapped with plastic sheeting to maintain the patches in position and retard evaporation of the test material. After 24 h the plastic wrappings and gauze patches were removed, and the intact and abraded test sites were scored separately for erythema and edema on a graded scale of 0 to 4; after 72 h, the sites were scored again. The mean primary irritation score (maxi- mum = 8) represents an average of the 24- and 72-h ratings of the intact and abraded sites. The mean primary irritation score of the test item was determined to be 0.9 (lower than 5) and thus, it was concluded not be an skin irritant.