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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3.0 - 3.3 kg (all female)
- Housing: polyethylene cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): approx. 40 - 60% rh
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: powder slightly moistened with water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 2.5 cm²
- Type of wrap if used: gauze, elastic wrap

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

OBSERVATION TIME POINTS
1, 24, 48, 72 h, 7, 14 d after removal

SCORING SYSTEM:
- Method of calculation: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corrosive effects were noted on treated skin at any time.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not cause signs of irritation/corrosion on rabbit skin. Slight erythema (below classification cut-off value) was fully reversible within 7 d. The substance is not classifiable according to the CLP Regulation.