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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:
2003-09-03 - 2003-11-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 404) performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted on 17th July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted on 31st July 1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: bulk
Details on test material:
Please refer to "Confidential details on test material".

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 - 4 months old
- Body weight at study initiation: 2.9 ± 0.2 kg
- Housing: animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30 - 70%
- Air changes: approximately 12 air changes/hour (filtered, non-recycled air)
- Photoperiod: 12 h / 12 h

IN-LIFE DATES: From: 2003-09-09 To: 2003-09-14

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg, moistened with purified water (gauze pad)
Duration of treatment / exposure:
4 h;
In the first instance, the test item was applied for periods of 3 minutes and 4 hours to a single male rabbit
Since the test item was not severely irritant on this first animal, it was then applied for 4 h to two other animals.
Observation period:
72 hours after patch removal (assessment of skin reactions at 1, 24, 48 and 72 hour(s) after patch removal)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: flank
- Type of wrap: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test item was wiped off by means of a dry cotton pad
- Time after start of exposure: 4 hours

SCORING SYSTEM: Scoring system according to OECD guidelines

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(all animals)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
(all animals)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
After 3-minute exposure (one animal) slight erythema was observed on day 1 and 2. After 4-hour exposure (three animals) a slight erythema was observed in 1/3 animals 1 hour after the removal of the dressing, otherwise no cutaneous reactions were recorded during the study. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU