Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Powder (grey)
- Storage condition of test material: Room temperature and humidity

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., PA, USA.
- Age at study initiation: ca 4.5 months.
- Weight at study initiation: 2.8 - 3.2 kg.
- Housing: 1/sex/cage.
- Diet (e.g. ad libitum): PMI Rabbit Chow, ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled, but not specified.
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12-hours light/dark.

IN-LIFE DATES: From: March 24, 2009 To: March 27, 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g / site.
- Concentration (if solution): Moistened with 0.2 mL distilled water to form a paste.
Duration of treatment / exposure:
Single application.
Observation period:
72 hours.
Number of animals:
3 females.
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (6.25 cm2)
- % coverage: ca 10%
- Type of wrap if used: Gauze patch, under porous (semi-occlusive) dressing.

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

SCORING SYSTEM: Erythema and edema were scored according to the numerical Draize Scale. The skin was also evaluated for ulceration, necrosis and evidence of tissue destruction.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: All
Score:
0
Max. score:
0
Irritant / corrosive response data:
Erythema or edema were not evident at 60 minutes, or at 24, 48 and 72 hours after patch removal.
Other effects:
There were no adverse clinical findings or effects on body weight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Given that the mean scores for both erythema and edema were 0, the test article was considered to be non-irritant.
Executive summary:

The test article was applied to the un-abraded skin of 3 female New Zealand White rabbits under a semi-occlusive dressing. The test article was applied at 0.5 g / site and was moistened with 0.2 mL of distilled water to form a paste. The test article was kept in contact with the skin for 4 hours. Residual test article was removed with distilled water prior to scoring. Test sites were scored for dermal irritation at 60 minutes and at 24, 48 and 72 hours following patch removal (Draize scale).

Given that the mean scores for both erythema and edema were 0, the test article was considered to be non-irritant.