Registration Dossier

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:
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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, 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.

Test system

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)

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.