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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:
30 Aug - 10 Sep 1982
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:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The test method used is in fact the Draize test method.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Sumilizer GM
- Analytical purity: >99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals, Shizuoka, Japan
- Weight at study initiation: 2.74 - 3.19 kg
- Housing: in fixing boxes during treatment period
- Diet, CG-3 type (Clea Japan Inc., Osaka, Japan), approx. 100 g/day
- Water: ad libitum, except for a period of 24 h after application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 60 ± 10

Test system

Type of coverage:
occlusive
Preparation of test site:
other:
Remarks:
clipped and abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g moistened with physiological saline
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: skin of the back
- Type of wrap if used: The test material was applied to 1 inch square lint patches The patches were held in place with an occlusive tape (Blenderm, surgical tape, 3M Co.).

REMOVAL OF TEST SUBSTANCE
- Washing: Treated skin was wiped to remove remaining test substance.
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24, 48 and 72 h and 7 days

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:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reaction was observed on abraded and clipped skin.

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:
CLP: not classified