2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-10-01 to 1985-10-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Perfluoroalkylethylacrylate

IUPAC Name:

Perfluoroalkylethylacrylate

Constituent 2

Reference substance name:

2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters

EC Number:

288-003-5

EC Name:

2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters

Cas Number:

85631-54-5

Molecular formula:

C11H7F13O2 - C17H7F25O2

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl prop-2-enoate; 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl prop-2-enoate; 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-henicosafluorododecyl prop-2-enoate; 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14-pentacosafluorotetradecyl prop-2-enoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

after 24 hours the eyes were washed out

Observation period (in vivo):

1h, 24, 48 and 72 hours

Number of animals or in vitro replicates:

three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

other: not irritant according to the CLP Regulation (EC 1272/2008)

Conclusions:

Based on the result of this test the test substance is considered to be not irritating to the rabbit eye.

Executive summary:

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, changes of the iris, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity, changes of the iris and chemosis of conjunctivae were 0.00 for all three animals. The individual mean score for conjunctivae reddening were 0.33, 0.00 and 0.00.

The instillation of the test item into the eye resulted in mild early onset and transient ocular changes, such as reddening of the conjunctivae. At the 1-hour reading a white to yellowish discharge was observed in one treated eye. These effects were reversible and were no longer evident after 48 hours after treatment.

Based on the result of this test the test substance is considered to be not irritating to the rabbit eye.