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Diss Factsheets

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:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
not mentioned
Deviations:
not specified
Principles of method if other than guideline:
According to the department of transportation act.
GLP compliance:
no

Test material

Constituent 1
Test material form:
solid: crystalline
Details on test material:
Colour: light yellow
Odour: Ammoniacal

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4, 24 and 48 h
Observation period:
24 h and 48 h
Number of animals:
6
Details on study design:
The intact and abraded skin of 6 albino rabbits was employed for this study. The hair was clipped from the backs with the aid of angora clippers. Four
areas of the back, placed approximately ten centimeters apart, were designated for the positions of the patches. Areas 2 and 3 were abraded by
making four epidermal incisions (two perpendicular to two others in the area of the patch). The patches consisted of 1. 5 inch x l. 5 inch 12 ply
gauze squares. The patches were secured to the area by thin bands of adhesive tape. The material to be tested 0.5 g was introduced beneath the patch.
The entire trunks of the animals were then wrapped in clear plastic trunk bands. The trunk bands help to hold the patches in position and retard evaporation of
volatile substances during the four hour exposure period. Upon removal of the patches the resulting reactions were evaluated on the basis of weighted
scores. Following this initial reading, all test sites were washed with appropriate solvent to prevent further exposure. Readings were again made
at 24 and 48 hours after the initial application.The test substance is evaluated on a total of site (6 abraded and 6 intact).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
no corrosion observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the skin irritation study no corrosion was observed.
Executive summary:

The study was performed in year 1976 according to the department of transportation act. 6 albino rabbits were used for the study. An Addendum to the report was prepared in year 1991.

Overall mean of erythema/eschar (intact skin 24 and 48 h): 0.0; overall mean of edema (intact skin 24 and 48 h): 0.0.

In conclusion, the substance is not corrosive to the skin.