Registration Dossier

Administrative data

Description of key information

Skin irritation: 
Key study: OECD guideline 404 and EU method B.4. GLP study.
All areas to be treated with the test substance and all control areas were normal before the application and at each observation time. Based on the results, the test substance is not a skin irritant.
Eye irritation:
Key study: OECD guideline 405 and EU method B.5. GLP study.
Based on the results, the test substance is not an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 6, 2006 to February 17, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the OECD Guideline 404 and EU method B.4, with GLP.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-94633 Sulzfeld.
- Weight at study initiation:
Animal No. 101: 2.1 kg
Animal No. 102: 2.3 kg
Animal No. 103: 2.4 kg

- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 height.
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Analysis of the feed for ingredients and contmainants is performed randomly by Altromin, D-32791 Lage, Germany. Hay. briquettes (supplied by SSniff, D-59494 Soest) are offered additionally as a dietary supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: 5 days (animal No. 101) and 12 days (animals Nos. 102 and 103)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19 ºC (continous control and recording)
- Humidity (%): Average of 48.8% (continous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: deoinised water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): Samples with approximately 0.5 mg of the test substance were moistened with 1.0 mL deionised water.
Duration of treatment / exposure:
4 hours.
Observation period:
The skins of the animals were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia) approximately 1, 24, 48 and 72 hous after patch removal.
Number of animals:
3 animals (first the test substance was administered to one animal; as no corrosive effect was observed in the inital test, the test substance was administered to two additional animals)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: "Blenderm" surgical tape, hypoallergenic, 3M, Medical products division, St. Paul, MN 551444, USA.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours.

SCORING SYSTEM:
Erythema/Eschar formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema

Oedema formation
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyonf area of exposure)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24 - 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All areas to be treated with the test substance and all control areas were normal before the application and at each observation time. Based on the results, the test substance is not a skin irritant.
Executive summary:

Assessment of the possible irritation/corrosion by the test substance following a single application to the intact skin of rabbits was determined according to the OECD Guideline 404 and B.4 EU Method, with GLP. 0.5 g of the test substance moistened with deionised water, was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing. The duration of exposure was 4 hours. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. All areas to be treated with the test substance and all control areas were normal before the application and at each observation time. Based on the results, the test substance is not a skin irritant.

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:

Key study: OECD guideline 404 and EU method B.4. GLP study.

All areas to be treated with the test substance and all control areas were normal before the application and at each observation time. Based on the results, the test substance is not a skin irritant.

Eye irritation:

Key study: OECD guideline 405 and EU method B.5. GLP study.

Based on the results, the test substance is not an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
In vivo study. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.

Justification for selection of eye irritation endpoint:
Only one study available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.

Justification for classification or non-classification

Based on the available results, the substance is not classified for irritation/corrosion.