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:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occluded exposure
Principles of method if other than guideline:
The animals were maintained on appropriate commercial diet and municipal water. Both are available ad libitum except during periods of fasting or manipulation. Male or female New Zealand White Rabbits are dosed with 0.5 ml (or 0.5 g for solids, moistened with water or other suitable vehicle). The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml (or 0.5 g) is lethal. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period. Excess sample is removed after contact. Skin reaction is scored by the Draize method at one hour, one day, 2 days, 3 days, 7 days, and, depending on the local skin reaction, possibly 10 and 14 days after dosing.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
other: moistened with corn oil
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
6 (3 male, 3 female)
Details on study design:
Male or female New Zealand White rabbits are dosed with 0.5 ml (or 0.5 g for solids, moistened with water or other suitable vehicle). The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml (or 0.5 g) is lethal. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period. Excess sample is removed after contact. Skin reaction is scored, by the method of Draize (given below), at one hour, one day, 2 days, 3 days, 7 days, and, depending on the local skin reaction, possibly 10 and 14 days after dosing.

Scoring was conducted accroding to the method of Draize.
DRAIZE SCORING SYSTEM FOR SKIN IRRITATION
Evaluation of skin reactions:
Erythema and eschar formation:
No erythema-------------------------------- 0
Very slight erythema (barely perceptible)---------------------- 1
Well-defined erythema------------------------------------------ 2
Moderate to severe erythema------------------------------------ 3
Severe erythema (beet redness) to slight eschar formation (injury in depth)----------------------------------------- 4

Edema formation:
No edema------------------------------------------------------- 0
Very slight edema (barely perceptible)------------------------- 1
Slight edema (edges of area well defined by definite raising)--------------------------------- 2
Moderate edema-(raised approximately 1 millimeter)------------- 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure)------------------------------ 4

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:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
See Skin Irritation Data in Attachments for details on results.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A 4-hour application to covered male and female rabbit skin resulted in no irritation throughout the 7 day observation period.
Executive summary:

A 4 -hour application of 0.5g of the substance (moistened with corn oil) to occluded rabbit skin resulted in no erythema, edema or other reaction on any of 6 animals. All dosed sited remained unaffected throughout the 7 day observation period.