Alcohols, C8-14, γ-ω-perfluoro

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-06-26 to 1984-06-29

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Perfluoralkylethanol

IUPAC Name:

2-Perfluoralkylethanol

Details on test material:

- Name of test material (as cited in study report): Code 06 HLAA 205
- Molecular weight (if other than submission substance): 445
- Physical state: yellowish liquid
- Analytical purity: 99%
- Purity test date: n.a.
- Lot/batch No.: E06 400 094
- Expiration date of the lot/batch: n.a.
- Storage condition of test material: in the dark at 22°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

60 min, 24 h, 48 h and 72h after treatment of the eye

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 37°C warm physiological sodium cloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: fluorescein, under UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animals #1, #2 and #3

Time point:

other: 24, 48 and 72 hours after application of test item

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animals #1, #2 and #3

Time point:

other: 24, 48 and 72 hours after application of test item

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48, and 72 hours after application of test item

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: none

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after application of test item

Score:

0

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

animals #1, #2 and #3

Time point:

other: 72 hours after application of test item

Score:

0.08

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test the test substance is considered to be "not irritant" to the rabbit eye.

Executive summary:

The acute eye irritating potential of the test item was investigated in three New Zealand White rabbits. The test item was applied by instillation of 0.1ml of the undiluted test substance into the left eye of each of three rabbits. Irritation effects were scored approximately 1h, 24 h, 48 h and 72h after test item instillation. 24 hours after instillation the eyes were rinsed with warm physiological saline solution.

The mean score was calculated across 3 scoring times (24h, 48h and 72h after instillation) for each animal. The individual mean scores for corneal opacity, conjunctival chemosis and changes of the iris were 0.00 for all three animals. The individual mean scores for the concunctivae reddening were 0.00, 0.33 and 0.00. The overall irritation score was determined 0.8. Based on the results of this test the test substance has not to be classified.