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:
May 14 1986 to May 28 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The study was conducted in accordance with GLP and similar/equivalent OECD 404 guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
impurity
Specific details on test material used for the study:
The test material is a UVCB

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the institute of Laboratory resources, National Research Council. Waste material was removed 3 times per week. Cages and feeders were sanitized every two weeks. Light cycle was 12hours light and 12hours dark. Food and water was provided ad libitum and checked daily, added or replaced as required.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5ml of the neat test material.
Duration of treatment / exposure:
The test material was applied and kept in contact with the skin for 4hours. At the end of the 4hrs exposure period, the wrapping were removed and skin wiped to remove remaining test material.
Observation period:
Animals were observed up to 14 days.
Number of animals:
six animals which includes 3 females and 3 males.
Details on study design:
The skin of each 6 adult abino rabbits were clipped free of fur. Test material was administered at one intact skin site. Following the application of the test material, one -inch square guaze patches were applied to each site. The trunk of each animal was then wrapped with a rubber dam and an Ace bandage to retard evaporation. The test material was kept in contact with the skin for 4hours. At the end of the 4hrs exposure period, the wrapping were removed and skin wiped to remove remaining test material.

Animals were observed for signs of erythema and edema and scored according to draize scale at 30-60minutes, 24 hours, 48 hours, 72 hours after application of test material and daily for 14days following application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 3.5
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Necrosis, fissuring, and sloughing observed.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2
Reversibility:
fully reversible within: 11 days
Irritant / corrosive response data:
Individual animal scores are given below for 30mins , 24 and 72 hours observations:

Endpoint TIME (hrs) Rabbit Number/Response
1 2 3 4 5 6

Erythema 24hrs 3 4 3 3 3 3
48hrs 3 4 3 3 3 4
72hrs 4 4 4 4 4 4


Edema 24hrs 4 4 4 4 4 4
48hrs 1 1 1 1 1 1
72hrs 1 1 1 1 1 1

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The results from the study considers the test material to be skin corrosive. Therefore, in accordance with the criteria set in the CLP guidance document, the substance should be classified as Skin Corrosive, Category 1 C, H314.
Executive summary:

The test substance was assessed for dermal corrosive effects on rabbit skin. Substance was applied to one intact skin site. Slight to severe erythema was observed throughout the study. Slight severe edema was observed through day 10. Necrosis, fissuring and sloughing were also observed and the study was terminated on day 14. Therefore, based upon the observations made in the acute dermal corrosion test in rabbits, the test substance was determined to be corrosive to the skin under CLP classification criteria.