Registration Dossier

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
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Limited material and methods but results usable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF-quality
Details on test animals and environmental conditions:
no details provided

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 gram of v184844 was applied to the intact skin of a shaved area on a flank of an albino rabbit.
Duration of treatment / exposure:
four hours
Observation period:
72 hours
Number of animals:
1
Details on study design:
The patch was fixed with a dressing, which was wrapped around the abdomen and secured with an elastic bandage. The application should be regarded as a semi-occlusive application. Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently dry tissue.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Four hours exposure to 0.5 grams of V184844 (CH02586) resulted in no skin irritation. V184844 (CH02586) resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin.