Registration Dossier

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: No detailed information upon Guideline followed. No GLP. Sufficient documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: The adjacent areas of untreated skin were used as negative control.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
other: 1 H
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 H
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 1,2,4,5,6
Time point:
other: 24 H
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 H
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 1,2,4,5,6
Time point:
other: 72 H
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 1 H
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 72 H
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 24 H
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 48 H
Score:
0
Max. score:
4

Any other information on results incl. tables

No dermal irritation was observed in five rabbits during the study. The remaining rabbit exhibited no dermal irritation at one hour and slight erythema at 24, 48, and 72 hours. No clinical signs were observed, and no body weight loss occurred during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, H-25285 was a slight skin irritant. According to the EU guidelines H-25285 probably should not be classified as irritant unless additional data proves otherwise.