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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
occlusive instead of semi-occlusive dressing; test substance is used as 3% and 20% aqueous solution instead of moistened solid

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive instead of semi-occlusive dressing; test substance is used as 3% and 20% aqueous solution instead of moistened solid
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: Broekman Instituut B.V.
- Age at study initiation: young adult
- Weight at study initiation: 1500-1900 g
- Acclimation period: 4 days

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 3% and 20%

Duration of treatment / exposure:
4 hrs
Observation period:
72 hrs
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Patches fixed with adhesive tape, and covered with occlusive wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, with water.
- Time after start of exposure: 4 hrs

OBSERVATION TIME POINTS
1, 24, 48, and 72 hrs after end of exposure.

SCORING SYSTEM:
- Method of calculation: Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No signs of redness or swelling was seen at any of the observations at either the 3% or 20% concentration.

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:
The test substance is considered to be not irritating to skin.
Executive summary:

Three rabbits were exposed to 3% and 20% test substance in water for 4 hrs under occlusive conditions. The exposed skin was then examined at 1, 24, 48, and 72 hrs after the end of the exposure. No signs of irritation were seen at any of the observations. Thus, under the test conditions used, the test substance was not irritant to the skin of rabbit.