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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:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP and no guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
according to the regulation of the Department of Transportation, Fed.Reg., § 173.1200
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Mean body weight: ca. 2.8 kg
The animals were offered Ssniff K, standard diet for rabbits and guinea pigs, supplied by INTERMAST GMBH, Soest, FRG, and water ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 g of an 80% aqueous test substance preparation
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
4
Details on study design:
The hair was removed from the dorsal and lateral parts of the trunk using electric clippers about 15 to 24 hours before application. Only animals with healthy and intact skin were used for the study.
The clipped dorsal skin of the rabbits was exposed to a test patch (about 2 x 2 cm) containing the test substance for 4 hours. The test patch was covered with a rubberised linen cloth that was secured in place by adhesive tape. After 4 hours the bandage was removed and the treated skin areas were washed with Lutrol or a mixture of water and Lutrol (1 : 1) and then dried with cellulose. The first findings were recorded after the bandage had been removed and then each working day. During the application the animals were restrained and did not receive any food.
Examinations:
a) Local irritation or corrosion
b) Signs of systemic toxicity
c) Necropsy of sacrificed animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 48 h
Score:
2.625
Max. score:
4
Reversibility:
other: not fully reversible within 8 days in 3 out of 4 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h, 48 h
Score:
1.875
Max. score:
4
Reversibility:
other: not fully reversible within 8 days in 1 out of 4 animals
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: parchment-like necrosis
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: parchment-like necrosis
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: spotty-necrotic skin lesion
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: within 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: parchment-like necrosis
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: parchment-like necrosis
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: spotty-necrotic skin lesion
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
After the 4-hour test substance application, initially distinct erythema and edema were observed. In the course of 8-day observation period, 2 of 4 animals showed parchment-like necrosis as a result of an irreversible skin damage. One animal showed a spotty-necrotic skin lesion. The skin findings were macroscopically confirmed by a pathologist. Parchment-like necosis are considered to present strong irritation (not corrosion).

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)