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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:
05 - 13 Jul 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

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
Details on test material:
Reactive Orange 64

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: 2.9 kg (mean, all male)
- Housing: polyethylene cages
- Diet (e.g. ad libitum): "Ssniff K 4" , Ssniff Spezialdiaten GmbH, Soer - approx. 100 - 120 g per animal and day; feeding once per day in the morning
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): approx. 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
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:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 8 x 8 cm²
- % coverage: 2.5 x 2.5 cm²
- Type of wrap if used: hypoallergenic patch

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

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

SCORING SYSTEM:
- Method of calculation: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
discolouration of skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corrosive or irritating effects were noted on treated skin at any time. At 24 h, no erythema could be determined appropriately since the substance discoloured the skin surface reddish to orange.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not cause any signs of irritation/corrosion on rabbit skin. The substance is not classifiable according to the CLP Regulation.