Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 to 30 July 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to current OECD test guidelines and GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

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:
- Name of test material (as cited in study report): E-Y110
- Physical state: Orange powder, solid
- Lot/batch No.: MB-1
- Expiration date of the lot/batch: July 6, 2015
- Storage condition of test material: Room temperature, in a dark place

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 10 weeks
- Weight at study initiation: 1883 g to 2013 g
- Housing: Aluminium cages (W318xH358xD498) with stainless steel cascade racks, one animal per cage.
- Diet (ad libitum):Pellet diet (LRC4, Oriental yeast Co., Ltd.), analysed per lot: contaminants confirmed to within the acceptable limits established by the testing facility.
- Water (ad libitum): well water admixed with sodium hypochlorite (about 0.2 ppm), analysed every 6 months: contaminants confirmed to within the acceptable limits in compliance with waterworks law, Japan.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24-26.1
- Humidity (%): 50.6-73,.2
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12

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

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 ml
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap: before applilcation, an Elizabeth collar was installed. The test substance (moistened with water) was placed on a patch (lint cloth) and placed on application area. The patch was fixed with a non-woven adhesive bandage and occluded by the adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cleaned with absorbent cotton moisturised with lukewarm water. Then the Elizabeth collar was removed.
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to OECD 404 for erythema and eschar formation and oedema formation. In addition the Primary Irritation Index (PII) was calculated according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema and eschar formation and oedema formation
Basis:
animal: #1, #2 and #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: #1, #2 and #3
Time point:
other: 1 and 48 hours
Score:
0
Max. score:
8
Irritant / corrosive response data:
All individual animals at any point in time did not show any irritation.
Other effects:
No clinical signs, no abnormal body weight gain were observed in any animal throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
E-Y110 had no irritation or corrosion potential on the rabbit skin under the conditions of this study (OECD 404).
Executive summary:

The acute dermal irritation or corrosion potential of E-Y110 was assessed in three male New Zealand White rabbits according to OECD test guideline 404. The test substance (0.5 g) was moistened with 0.3 ml of water. As a result of the 4 -hour exposure (semi-occluded application) no skin reactions were observed in any animal at any observation time. Therefore, primary irritation index (PII) was 0 and evaluated as not irritating. In conclusion, E-Y110 had no irritation or corrosion potential to the rabbit skin under the conditions of the study.