Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 - 26 Apr 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Y-15866
- Physical state: colourless liquid
- Analytical purity: 72%
- Lot/batch No.: 3710-10
- Expiration date of the lot/batch: 2013-07-16
- Storage condition of test material: at room temperature (20 ± 5 °C) and light-protected
- Other: stability under storage conditions: yes

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France and Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 20 weeks (male) and 10-13 weeks (females)
- Weight at study initiation: 3815 g (male) and 2290-2314 g (females)
- Housing: animals were housed individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10, Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 102240, ABEDD® - LAB & VET GmbH, Vienna, Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, Kaiseraugst, Switzerland) were also provided for each animal.
- Water: community tap water from Füllinsdorf, Switzerland, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 Apr 2010 (one female) or 21 Apr 2010 (the male and the second female) To: 26 Apr 2010

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
6 (one male and one female) or 7 days (one female)
Reading time points: 1, 24, 48 and 72 h
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the left flank
- Type of wrap if used: the test substance was placed on a surgical gauze patch, which was held in contact with the skin by means of an adhesive hypoallergenic aerated semiocclusive dressing and a restrainer bandage wrapped around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008, B.4, Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. The individual mean erythema/eschar and edema score for each of the three animals was therefore 0. No staining and no corrosive effects were observed on the treated skin.
Other effects:
No further local or systemic effects were observed.

Applicant's summary and conclusion

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

The skin irritation potential of Y-15866 was investigated in a GLP-conform study according to OECD guideline 404. The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 young adult New Zealand White rabbits (1 male and 2 females) under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. No signs of systemic toxicity were seen. The mean erythema and edema scores over 24, 48 and 72 h were 0 for all 3 animals.