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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:
04 Dec 2001 to 14 Dec 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accordance with good laboratory practice (GLP) regulations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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): Perfluormethoxypropylvinylether
- Substance type: Clear colorless liquid
- Physical state: Liquid
- Analytical purity: 98%
- Purity test date: 30 Jul 2000
- Lot/batch no.: Lot 3
- Expiration date of the lot/batch: 31 Dec 2002
- Storage condition of test material: Darkness at approximately 5 C in a refrigerator under nitrogen atmosphere

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: 3.2-4.0 kg
- Housing: Individually in cages
- Diet (e.g. ad libitum): Ssniff K-H (V2333) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period:1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 04 Dec 2001 To: 14 Dec 2001

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females were dosed
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were washed with with isotonic saline 24 hours after starting the exposure to the test substance.
- Time after start of exposure: 24 hours.
SCORING SYSTEM: Cornea: 0-4, Iris: 0-2, Conjunctivae (Redness 0-3, Chemosis 0-4, Discharge 0-3).
TOOL USED TO ASSESS SCORE: UV lamp and fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
ca. 0 - ca. 0.33
Reversibility:
fully reversible
Remarks on result:
other: Scale 4
Irritant / corrosive response data:
A conjunctivae redness score of 1 was observed in a single animal at the 24 hour observation period and had resolved by the 48 hour observation. No other scores were noted at any other animals at any other point during the study.

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 material is not an eye irritant.
Executive summary:

The eye irritation potential of the test material was determined in New Zealand White rabbits (3, female). The study was conducted according to OECD GLP (1999). The test method was based on OECD 405 (1987), EEC Method B.5 (1992), and US EPA OPPTS 870.2400 (1998). 0.1 mL of the test material was instilled in the conjunctival sac of the left eye of each animal. The right eye of each animal was left untreated to serve as a control. 24 hours after administration the treated eyes were washed thoroughly with isotonic saline. The eyes were examined at 1, 24, 48, and 72 hours. At 24 and 72 hours, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. The cornea (0-4), Iris (0-2), and Conjunctivae (Redness: 0-3, Chemosis: 0-4, and Discharge; 0-3) were examined and scored appropriately at each of the observation period. A conjunctivae redness score of 1 was observed in a single animal at the 24 hour observation period and had resolved by the 48 hour observation. No other scores were noted at any other animals at any other point during the study. Based on the results of the study, the test material is not an eye irritant.