Perfluamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 March 1994-5 May 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study does not indicate adherence to GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

T-5912

IUPAC Name:

T-5912

Details on test material:

- Name of test material (as cited in study report): T-5912
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HRP, Inc., Kalamazoo, MI
- Age at study initiation: adult
- Weight at study initiation: 3027-3471
- Housing: indivudal screen-bottom cages
- Diet (e.g. ad libitum): controlled
- Water (e.g. ad libitum): controlled
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled.
- Air changes (per hr): not stated
IN-LIFE DATES: From: 31 March 1994 To: 3 April 1994

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0-.1 mL

Duration of treatment / exposure:

Only for a few seconds during test substance instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3/sex/dose

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sodium fluorescein examination was dose to reveal potential corneal injury
- Time after start of exposure: 72 hours
SCORING SYSTEM: Draize (1959) technique
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

other: Primary Irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

0% of the test animals at all time points responsed to the test article.

Any other information on results incl. tables

All cornea, iris, and conjunctivae irritations cores were zero for all animals at all time points. The sodium fluorescein examination was negative, indication no corneal damage.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

The test article, T-5912, when evaluated for its primary eye irritation potential in rabbits, produced no occular irritation.

Executive summary:

The ocular irritation/corrosion potential of T-5912 was assessed in New Zealand White rabbits. The undiluted test article (0.1 mL) was placed into the everted lower lid of the right eye, with the left eye serving as the untreated control. The upper and lower lids were held together for 1 second and then released. The eyes remained unflushed. The treated eyes were observed for ocular irritation at 1, 24, 48 and 72 hours after treatment. Irritation was scored using the Draize technique. A sodium fluorescein examination was used to reveal possible corneal damage at 72 hours. Average primary irritation scores and individual eye irritation scores for cornea, iris, conjunctivae irritation were reported. All animals and all time points had irritation scores of zero. The test article, T-5912, when evaluated for its primary eye irritation potential in rabbits, produced no ocular irritation.