Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: The test item is not classified as skin irritant.
Eye irritation/corrosion: The test substance was found not to be severely eye damaging.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted: 2002-04-24
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
cited as: directive 2004/73/EG method B.4
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ferenc Sandor breeder 2173 Kartal, Voros HUNGARY
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2606-2875 g
- Housing: Animals were housed individually in metal cages.
- Diet: The animals received PURISTAR standard diet for rabbit produced by AGRTBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: The animals received as tap water from automatic self-service water system ad libitum.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchange/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A volume of 0.5 mL of test item was applied in substantia to the skin of the experimental animals. The test item was applied as single dose. Untreated skin of each animal served as control.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: aprroximately 6 cm²
- Type of wrap if used: Sterile gauze pads were placed on the skin of rabbits. These gauzes were kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize (1959)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
One hour after the patch removal, two animals developed well defined erythema on the treated skin surface (score 2). The other animal 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. In two animals well defined to very slight erythema were recorded 24 and 48 hours after patch removal (score 2, 1), on the treated skin surface.
Other effects:
no other effects obseved
Interpretation of results:
GHS criteria not met
Conclusions:
The animal individual mean scores for erythema and oedema were 1.33, 0.66 and 0.00 and 0.00, 0.00 and 0.00, respectively. Thus, according to Regulation (EC) No 1272/2008 the test item is not classified as skin irritant.
Executive summary:

A study was conducted according to OECD TG 404 and Directive 2004/73/EG method B.4. The test was performed in albino New Zealand white rabbits. The test item was administered in a pure state, as a single dose of 0.5 ml, to the shaved skin of all experimental rabbits. One hour after the patch removal two animals developed well defined erythema (score 2) occurred on the treated skin surface. The other animal did not develop symptoms of primary irritation, such as erythema and oedema, or did any other adverse effects develop throughout the observation period, either at the treatment or the control areas. At 24 and 48 hours after patch removal, two animals showed well defined and very slight erythema on the treated skin surface (score 2, 1). At 72 hours after patch removal no irritation symptoms (erythema and oedema) was recorded for any of the animals and the study was terminated. Thus, acoording to Regulation 1272/2008 the test item is not classified as skin irritant.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

A study was conducted according to OECD TG 404 and Directive 2004/73/EG method B.4. The test was performed in albino New Zealand white rabbits. The test item was administered in a pure state, as a single dose of 0.5 mL, to the shaved skin of all experimental rabbits. One hour after the patch removal two animals developed well defined erythema (score 2) occurred on the treated skin surface. The other animal did not develop symptoms of primary irritation, such as erythema and oedema, or did any other adverse effects develop throughout the observation period, either at the treatment or the control areas. At 24 and 48 hours after patch removal, two animals showed well defined and very slight erythema on the treated skin surface (score 2, 1). At 72 hours after patch removal no irritation symptoms (erythema and oedema) was recorded for any of the animals and the study was terminated. Thus, acoording to Regulation (EC) No 1272/2008 the test item is not classified as skin irritant.

Eye Irritation

SIKA Hardener LTJ In Vitro Test for Eye Corrosives and Severe Irritants in Isolated Chicken Eyes (ICET). The purpose of this test was to evaluate the potential ocular corrosivity or severe irritancy of the test item SIKA Hardener LTJ by its ability to induce toxicity in enucleated chicken eyes. The test compound was applied in a single dose onto the cornea of isolated chicken eyes in order to potentially classify the test compound as ocular corrosive and/or severe irritant. The SIKA Hardener LTJ, Acetic acid 10 % (v/v) solution (positive control) and NaCl (9 g/L saline) (negative control) were applied in a volume of 30 μL/eye, in such a way that the entire surface of the cornea attempting to cover the cornea surface uniformly with the test substance or positive or negative control. Three test item treated eyes, three positive control eyes and one negative control eye were used in this study. After an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with ~20 mL saline solution at ambient temperature and this procedure was repeated for each eye. In this ICET, SIKA Hardener LTJ did not cause ocular corrosion or severe irritation in the enucleated chicken eyes. Positive and negative controls showed the expected results. The experiments were considered to be valid. As a conclusion, the substance was found to be not severely eye damaging. According to OECD 438, the test substance was therefore not classified for severe eye irritation or corrosion.



Justification for classification or non-classification

Based on the results obtained from testing the test item was not classified and labled with regard to skin irritation / corrosion according to Regulation (EC) No 1272/2008 (CLP), respectively. The test item was further not classified as severely eye damaging according to Regulation (EC) No1272/2008 (CLP).