Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in compliance with OECD (1992), Swiss Procedures and Principles (1986), US FDA (1991), and Japanese Ministry of Health and Welfare Good Laboratory Practice principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

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
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Procrylat
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: >90%
- Purity test date: No data
- Lot/batch No.: P 2274001
- Expiration date of the lot/batch: July 1997
- Storage condition of test material: At room temperature away from direct sunlight

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
Birkendorferstrasse 65
D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Weight at study initiation:
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no. 75/97)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12 March 1997 To: 20 March 1997

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (2 female, 1 male)
Details on study design:
TEST SITE
- Area of exposure: Dorsal
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The area of exposure was flushed with lukewarm tap water after 4 hours.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: No erythema or edema was observed in any animal at any time point.
Irritant / corrosive response data:
No erythema or edema was observed in any animal at any time point throughout the observation period.
Other effects:
No clinical signs of sytemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study (all scores were 0; PII = 0), the test article is not a dermal irritant.
Executive summary:

The primary skin irritation potential of the test article (liquid, batch P2274001) was evaluated in New Zealand White rabbits. This study was conducted in accordance with Swiss GLP (1986), OECD GLP (1992), US FDA GLP 21CFR58, Japan MHLW (1988). The study design was based on Directive 92/69/EEC, B.4 (1992) and OECD 404 (1993). The test article was administered as received. Hair was clipped from the dorsal skin of three rabbits (1 male, 2 females). The test article (0.5 mL) was applied to a 6 cm2 area on the skin. Gauze was used to cover the site and create a semi-occlusive dressing. The dressing was secured around the abdomen with tape for a 4-hour exposure. Observations for skin irritation (erythema and edema) were recorded at 1, 24, 48 and 72 hours after unwrapping. The Primary Irritation Index (PII) was calculated. There were no abnormal clinical signs or changes in body weight. All erythema and edema scores were 0 throughout the study and the PII was 0. Based on the results of this study (all scores were 0; PII = 0), the test article is not a dermal irritant.