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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in compliance with OECD GLP (1997) regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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): Pefluorpropylvinylether
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.1%
- Purity test date: 14 January, 2000
- Lot/batch No.: 10B1001
- Expiration date of the lot/batch: 14 January, 2001
- Stability under test conditions: No data
- Storage condition of test material: In darkness at approximately 20 C in a fume cupboard unser inert conditions (N2)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: No data
- Weight at study initiation: 2.9-3.4 kg
- Housing: Individually
- Diet (e.g. ad libitum): Ssniff K-H (V2333), ad libitum and hay (15 g daily).
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 C
- Humidity (%): 30-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 March, 2000 To: 11 April, 2000

Test system

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

VEHICLE: None
Duration of treatment / exposure:
24 hours (washing of the treated eye was conducted after this period)
Observation period (in vivo):
1, 24, 48, and 72 hours after administration of the test substance. The eyes were further examined at 24 hours, 72 hours, 7 and 14 days for corneal lesions under UV light after the instillation of one drop of 0.01% fluuorescein-sodium solution.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after instillation of the test article
- Time after start of exposure: 24 hours

SCORING SYSTEM: Cornea opacity: 0-4, Iris redness: 0-2, Conjunctivae redness: 0-3, Conjunctivae chemosis: 0-4, Conjunctivae discharge: 0-3,

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Corneal opacity
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
ca. 0.44
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
Conjunctiva redness
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
ca. 1.89
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72
Score:
ca. 1.11
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Mean values (over 24, 48 and 72 hours) for each animal: corneal opacity (0.0, 1.0, 1.0); iritis (0.0, 0.67, 0.67); conjunctival redness (0.33, 2.67, 2.67); and conjunctival chemosis (0.0, 1.67, 1.67). Conjunctival redness persisted through Day 7. The animals were normal at 14 days after dosing

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article is a severe ocular irritant.
Executive summary:

The primary eye irritation potential of the test article (liquid, batch 10B1001) was evaluated in New Zealand White Rabbits. This study was performed in accordance with OECD GLP (1999). The study design was based on OECD 405 (1987) and Directive 92/69/EEC guideline B.5 (1992). Approximately 24 hours prior to the study the eyes of all animals were examined using a fluorescein solution. Animals without ocular abnormalities were selected for this study. The test material (0.1 mL) was administered as received to the conjunctival sac of the left eye of three rabbits. The contralateral eye served as the control. The treated eyes were washed with 37 C saline at 24 hours post-dose. The eyes were examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours and 7 and 14 days post-dose using the Draize technique. Sodium fluorescein dye procedures were used at 24 and 72 hours and at 7 and 14 days after dosing to improve the evaluation of the cornea. Mean values (over 24, 48 and 72 hours) for each animal: corneal opacity (0.0, 1.0, 1.0); iritis (0.0, 0.67, 0.67); conjunctival redness (0.33, 2.67, 2.67); and conjunctival chemosis (0.0, 1.67, 1.67). Conjunctival redness persisted through Day 7. The animals were normal at 14 days after dosing. Based on the results of this study, the test article is a severe ocular irritant.