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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
3 white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythema, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
content: 99.1%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
White New Zealand rabbits, weight 2.9 to 3.3 kg; husbandry: standardized conventional conditions in individual stainless steel cages.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount: 500 µl
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Other effects:
no data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Method: 3 white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days

Result: slightly irritating to the skin, but not sufficient for classification

Reference: Maertins (Bayer AG), 1989