Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with OECD GLP (1992), Swiss GLP (1986), US FDA GLP (1991), and Japanese Ministry of Health and Welfare GLP regulations.

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 405 (Acute Eye 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: >96%
- 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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: Male: 3071 g, Female Mean: 3162 g
- 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 Kilba 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: 19 March 1997 To: 27 March 1997

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of each animal was left untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
The test article was instilled into the left eye of each animal and observed 24, 48, and 72 hours after instillation.
Observation period (in vivo):
Eyes were observed 24, 48, and 72 hours after instillation.
Number of animals or in vitro replicates:
3 (1 male, 2 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were not flushed

SCORING SYSTEM: Scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992.
Cornea: 0-4, Iris: 0-2, Conjunctivae Redness: 0-3, Conjunctivae Chemosis: 0-4

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
ca. 0.67
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
There was no corneal opacity, iritis or confunctival chemosis at any time during the study. Conjunctival redness was observed in all animals at 1 hour after dosing (scores: 1, 2 and 2; average: 1.67) that persisted through 48 hours after dosing (scores: 1, 1, and 1; average 1.00). All animals were normal at 72 hours after dosing. The mean total score for ocular irritation was 0.67/110.

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 the study, the test article is not an ocular irritant.
Executive summary:

The primary eye irritation/corrosion potential of the test article (liquid, batch P2274001) was evaluated in New Zealand White Rabbits. This study was performed 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.5 (1992) and OECD 405 (1987). The test material (0.1 mL) was administered as received to the conjunctival sac of one eye of each rabbit (1 male, 2 females) by gently pulling the lower eyelid away from the eye. The lids were held together for approximately one second after administration to insure adequate distribution of the test material. The contralateral eye of each animal served as the control. The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose using the Draize technique. There were no systemic clinical signs, corneal opacity, iritis or conjunctival chemosis at any time during the study. Conjunctival redness was observed in all animals at 1 hour after dosing (score: 1, one animal and 2, two animals; average: 1.67) that persisted through 48 hours after dosing (scores: 1; average 1.00). All animals were normal at 72 hours after dosing. The individual animal mean conjuctival redness scores (24 -72 hours) were 0.67, 0.67, and 0.67. The mean total score for ocular irritation was 0.67/110. Based on the results of the study, the test article is not an ocular irritant.