Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 - 4 months
- Weight at study initiation: 2.5 ± 0.3 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): ad libitum, 110 pelleted diet (SAFE, villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water (filtered)
- Acclimation period: 5 days (at least)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle was applied
Duration of treatment / exposure:
3 minutes and 4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flanks
- Type of wrap if used: gauze pad (moistened with purified water) , held in contact with the skin by means of an adhesive
hypoallergenic aerated semi-occlusive dressing and a restraining bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of residual test item: by using a dry cotton pad (no washing)
- Time after start of exposure: 3 minutes and 4 hours first on one animal and 4 hours for the further two animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. score: 1 (one animal, 24 h, erythema)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. score: 1 (one animal, 24 h, erythema)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. score: 1 (one animal, 24 h, erythema)
Irritation parameter:
edema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. score: 1 (one animal, 24 h, erythema)
Irritation parameter:
edema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. score: 1 (one animal, 24 h, erythema)
Irritation parameter:
edema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. score: 1 (one animal, 24 h, erythema)
Irritant / corrosive response data:
very slightly irritant
Other effects:
Very slight erythema on day 1 two animals. Persisting on day 2 for one rabbit.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified.