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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:
guideline study with acceptable restrictions
Remarks:
non-GLP, occlusive coverage, no washing after 24 h exposure

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Before OECD Guideline 404 was established in 1982, skin irritation was tested according to the acknowledged Draize test method.
An amount of 0.5 mL of test material was applied to a skin area of 2.5 x 2.5 cm under occlusive conditions for 24 hours. The application site was either intact or scarified. The application site on the intact skin was located dorsally whereas scarified skin was located on the left side. Skin findings were assessed after 24 hours, 48 hours, 72 hours and after 8 days. The assessment of the findings was based on the Federal Reg. 38, No. 187, Para. 1500.41, page 27029 (1973).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.50 kg
- Diet: Sniff

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
Concentration: 50 %
Duration of treatment / exposure:
24 h
Observation period:
8 d
Number of animals:
6 (4 male, 2 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
evaluation of erythema after 24 h not possible due to treatment related staining.
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Intact skin: Evaluation of erythema after 24 h not possible due to treatment related staining. No oedema or erythrema noted during the entire evaluation period.

Abraded skin: Evaluation of erythema after 24 h not possible due to treatment related staining. After 72 h questionable to slight erythema in 3/5 animals (1 animal evaluation impossible due to substance-related staining); scaling in 4 animals after 8 d. Edema: no effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met