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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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, but well reported. Testing procedure more stringent than OECD testing guideline 404.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The Draize test was used to assess primary skin irritation. Six rabbits were used. The back of each rabbit was clipped free of hair 24 h before application of the mixture. Four sites, two intact and two abraded, were established. The material was applied at each location. The test sites were covered with a gauze pad and the entire back was overlaid with an adhesive plastic surgical drape. Each rabbit was then placed in a rabbit jacket. The jackets and wraps were removed 24 h later, and each test site was scored visually for erythema and edema. Readings were recorded at 24, 48, and 72 h. A final irritation score was calculated for the 24- and 72-h readings.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Storage condition of test material: 25 °C in a glass container sealed inside a polyethylene bag

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Keen Ridge Rabbit Ranch, Edgewood, New Mexico
- Weight at study initiation: 2.0 - 3.0 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved and abraded
Vehicle:
other: corn oil
Controls:
no
Amount / concentration applied:
500 mg substance in 0.5 mL of corn oil
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Back
- Type of wrap if used: The test sites were covered with a gauze pad, and the entire back was overlaid with an adhesive plastic surgical
drape.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
None of the 6 rabbits exhibited edema or erythema in 24 h; therefore, all animals were judged normal. The total primary irritation score was 0.00.