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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
(only basic information given; occlusive type of coverage, only 48 h observation period)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
abraded skin was additionally tested, but not used for evaluation
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
48 h
Reading time points: 4, 24 and 48 h
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap if used: The patches (1.5 inch x 1.5 inch 12 ply gauze squares) were secured to the area by thin bands of adhesive tape. The entire trunks of the animals were then wrapped in clear plastic trunk bands.

REMOVAL OF TEST SUBSTANCE
- Washing: Test sides were washed with appropraite solvent
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
4, 24 and 48 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Very slight edema were observed after the exposure period at 4 h on abraded skin in all animals. These effects were fully reversible within 24 h.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
Under the conditions of this skin irritation study the test substance was not irritating.
Executive summary:

In a test for skin irritation, rabbits were exposed to test material (test site occluded), following detailed examinations, post-exposure, the test substance was demonstrated not to be irritating.