Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Aug 2005 - 28 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12-Nousan-No.8147, Skin Irritation Study
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: KITAYAMA LABES Co., Ltd. (Ina, Japan)
- Age at study initiation: 15 weeks
- Weight at study initiation: 2.73 - 2.88 kg
- Housing: The animals were caged individually in suspended aluminium cages with stainless steel wire-meshed front and floor (W45 x D55 x H35 cm, Yamato Scientific Co., Ltd., Japan). The cages were placed on racks. Cages were changed once per two weeks with washed and sterilized ones.
- Diet: Approximately 120 g/day of LRC4 (Lot No. 050518, Oriental Yeast Co., Ltd., Japan).
- Water: Filtered tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2 (actual temperature measured: 21.7 - 22.2 °C)
- Humidity (%): 30 - 70 (actual humidity level measured: 51.7 - 71.9%)
- Air changes (per hr): More than 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
The powder was moistened with 0.5 mL of water for injection.
Controls:
no
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
4 hrs
Observation period:
72 hrs
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The gauze patch (translated as 'lint patch' from the Japanese) with the test substance was held in place with surgical tape and a pressure bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed area of skin was wiped with adsorbent cotton dipped in tap water.
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
Performed according to the Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: No effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: No effects

Any other information on results incl. tables

No clinical effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information