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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:
April 2007 - May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
none

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste - F40260 Linxe)
- Weight during the test: 2.23 kg .- 2.92 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Acclimation period: 5-day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19°C and 22°C
- Humidity (%): between 40% and 70%
- conventional air conditioned

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dose of 0.5 g

Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were appreciated I hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed 72 hours after the treatment the study is terminated
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: on an undamaged skin area of one flank of each animal
- Type of wrap if used: strip of surgieal adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with distilled water
- Time after start of exposure:

SCORING SYSTEM:

Erythema and Eschar formation:
0 ...... No erythema
1 ...... Very slight erythema (barely perceptible)
2 ...... Well defined erythema
3 ...... Moderate to severe erythema
4 ... ... Severe erythema (beef redness) with eschars formation preventing grading of erythema

Oedema:
0 ....... No oedema
1 ....... Very slight oedema (barely perceptible)
2 ....... Slight oedema (contour clearly defined)
3 ....... Moderate oedema (raised approx. 1 mm)
4 ...... Severe oedema (raised more than 1mm, and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema and eschar
Basis:
animal: #1,#2,#3
Time point:
other: 1,24,48,72 hours
Score:
0
Max. score:
4
Reversibility:
other: No cutaneous reactions
Irritation parameter:
edema score
Basis:
animal: #1,#2,#3
Time point:
other: 1,24,48,72 hours
Score:
0
Max. score:
4
Reversibility:
other: No cutaneous reactions
Irritant / corrosive response data:
- Raw data for each individual animal at each observation time up to removal of each animal from the test: data are given in above block of fields
'Irritation / corrosion results'.
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not to be classified
Executive summary:

The test item was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing

during 4 hours on an undamaged skin area of three New Zealand rabbits.

No cutaneous reactions (el)'thema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours).