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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:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to OECD 404 and conducted according to GLP of the US EPA, CFR Part 792

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
small deviations
Principles of method if other than guideline:
no step-wise approach used, 6 animals used
exposed skin area 10 cm2 instead of 6 cm2
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Clear liquid
- Used as received

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Six healthy New Zeland Albino rabbits ( 3 males and 3 females ) 2.0 -2,.4 kg bw were individually caged with a light/dark cycle of 12 hours under temperture controlled conditions.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of the test article was applied.
Duration of treatment / exposure:
4 hrs
Observation period:
14 days;
Observation points: > 1hrs , 24 hrs, 48 hrs, 72 hrs, 7 d, 14d
Number of animals:
6: 3 males and 3 females
Details on study design:
similar to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30 min to 1 hrs
Score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hrs
Score:
0.83
Max. score:
1
Remarks on result:
other: 1/6 brown areas on the skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hrs
Score:
1.67
Max. score:
2
Remarks on result:
other: 1/6 brown areas on the skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hrs
Score:
1.67
Max. score:
2
Remarks on result:
other: 1/6 brown areas on the skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 days
Score:
2.5
Max. score:
4
Remarks on result:
other: 5/6 flaking skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: day 14
Score:
0.5
Max. score:
1
Remarks on result:
other: 1/6 poor hair regrowth, 2/6 flaking skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30 min to 1 hr
Score:
3.33
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hrs
Score:
2.83
Max. score:
3
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hrs
Score:
2.17
Max. score:
3
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hrs
Score:
1.83
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 d
Score:
1.66
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14 d
Score:
0.5
Max. score:
1

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:

Under the conclusion of this study, the test article is an irritant but not corrosive and thus fulfill the CLP-classification criteria as Skin Irrit 2, H315.
Executive summary:

Six healthy New Zeland Albino rabbits ( 3 males and 3 females ) were dosed dermally with SR 256 HXF 0946. 0.5 ml of test article was applied under semi-occlusive conditions on intact clipped skin. The test article was kept in contact with the skin for 4 hours. Draize scoring was performed after ½-1, 24, 48, 72 hours and 7 and 14 days. The scoring indicated the substance to be a moderate to severe irriatant but not a corrosive as irreversible damage and necrosis was not observed.

According to the CLP-criteria the substance should be classified as Skin Irrit 2, H315.