Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
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:
1978
Report Date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: US Federal Register 38 No. 187 §1500.41
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
one exposure at 0 h
Observation period:
8 d
Number of animals:
6
Details on study design:
Calculation based on Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
due to strong staining, no erythema score could be derived
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Due to a strong staining of the skin at the treated surface, no erythema score could be determined. However, no edema occured and no erythema was observed after 8 d.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not cause any signs of irritation on rabbit skin. Although no erythema score could be determined at 24/48/72 h due to strong staining, no signs of irritation were observed after 8 d.