Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 January - 04 February 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD ) and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): PD 283 XX
- Physical state: yellow powder
- Analytical purity: 97.6 % (HPLC)
- Analysis test date: 12 january 2006
- Purity to be retested: january 2007
- Lot/batch No.: V12TFA00072
- Storage condition of test material: 20°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH & Co. KG
- Age at study initiation: approximately 6 - 12 months
- Weight at study initiation: 3.3 – 4.4 kg (day of application)
- Housing: individually in solid wire cages
- Diet (e.g. ad libitum): Dry food (Kliba No. 3413.0.25, Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland), ad libitum
- Water (e.g. ad libitum): municipal drinking water were supplied ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2°C
- Humidity (%): 45-75 %
- Air changes (per hr): approximately 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 h, with lights on from 6:00 h to 18:00 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
ca. 500 mg per animal
Duration of treatment / exposure:
1 female: 3 min, 1h and 4 hours
2 females: 4h
Observation period:
1 h, 24 h, 48 h, 72 h after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm², dorsal skin of the rabbit
- Type of wrap if used: muslin tissue, non-skin-irritating plaster

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study PD 283 XX was well tolerated subsequent to topical application on rabbit
skin. There were no macroscopic signs of irritation or corrosion. In addition, there were no
signs of systemic side effects or of skin alterations beyond the area of exposure.