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Diss Factsheets

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:
other: Non-guideline study, limitations in reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Primary dermal irritation study
GLP compliance:
no

Test material

Constituent 1
Details on test material:
Kryocide Insecticide: NB 84-146-2B

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Young adult rabbits (approximately 14 weeks of age) of the New Zealand White strain were maintained individually in screen bottom cages in temperature and humidity controlled quarters, provided continuous access to commercial laboratory feed and water, and held for acclimation period of at least 7 days.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: moistened with sterile 0.9% saline
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
3 males and 3 females
Details on study design:
Three male and three female acclimated animals were chosen at random for the test, treated and maintained during the observation period as specified for the acclimation period. Test animals were identified by animal number and corresponding ear tag. 24 hours before treatment the hair was clipped from the back and flanks of each animal.

Test material was prepared as submitted, moistened with sterile 0.9% saline.

Just before the test material applied, criss-cross epidermal abrasions were made on two exposed areas of each rabbit to provide two abraded and two intact test sites (the abrasions were sufficiently deep to penetrate the stratum corneum, but not deep enough to penetrate to the deeper layer and cause bleeding). The test material was applied to the four test sites on each rabbit in the amount of 0.5 g per site. Each treated area was covered with a 5.0 x 6.0 cm gauze patch secured with paper tape and overwrapped with saran wrap to maintain the test material in contact with the skin and decrease the rate of evaporation. Collars were applied to the animals for the 24 hours treatment period.

After treatment the patches were removed and the test material was wiped (not washed) from the area as thoroughly as possible without irritation to the skin. The degree of erythema and edema was read according to the Draize technique. A second reading was taken at 72 hours to determine the primary irritation index.

At study termination all animals were euthanatized and discarded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary skin irritation scores (Draize)
Basis:
mean
Time point:
other: 24
Score:
0
Irritation parameter:
other: primary skin irritation scores (Draize)
Basis:
mean
Time point:
other: 72
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: intact site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: intact site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: abraded site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: abraded site
Irritant / corrosive response data:
The results indicate that the substance is not irritating to the skin.

Applicant's summary and conclusion