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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:
2005-06-27 to 2005-09-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ferenc Sandor Breeder; 2173 Kartal; Vörös Hadsereg Street 131; Hungary;
- Age at study initiation: 11 weeks;
- Weight at study initiation: 2918 - 3157 g;
- Housing: individually in metal cages;
- Diet: PURISTAR Standard Diet for Rabbits; AGRIBRANDS Europe Hungary PLC; H5300 Karcag, Madarasi road; Hungary; ad libitum;
- Water: tap water ad libitum;
- Acclimation period: 8 days;

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: 8 - 12 air changes/hr by central air-condition system;
- Photoperiod: 12 hrs dailiy from 6.00 a.m. to 6.00 p.m.;

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin of each animal served as control.
Amount / concentration applied:
0.5 mL of test item applied in a single dose;
Duration of treatment / exposure:
4 hours;
Observation period:
1 hour, 24, 48 and 72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: plastic wrap

OBSERVATION TIME POINTS
- 1 hour, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
11368/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
11325/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
11389/M
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:
0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
11368/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
11325/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
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:
One hour after the patch removal, one animal (no. 11368) developed very slight erythema on the treated skin surface (score 1). The other two animals (No. 11325, 11389) developed no primary irritation symptoms, such as erythema and oedema, or other adverse effects during the observation period, either at the treatment or the control application areas.
Other effects:
NA

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item SIKA Hardener LH is not considered to be irritant to rabbits' skin.
Executive summary:

Sika Hardener LH (VP) was tested for skin irritation properties in a study with albino New Zealand White rabbits. The test material was applied to the intact skin of rabbits as a single dose of 0.5 mL. The irritation symptoms were examined at 1, 24, 48 and 72 hours after the patch removal. In one animal, very slight erythema were recorded 24 and 48 hours after patch removal (score 1), on the treated skin surface. All animals were free of irritation symptoms (erythema and oedeme) 72 hours after patch removal. Thus, the study was terminated after 72 hours.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.66. 0.00 and 0.00 and 0.00, 0.00 and 0.00 respectively. The observed symptoms were evaluated as fully reversible alterations.

No skin irritation properties were found in the test with Sika Hardener LH.