3,3,4,4,5,5,6,6,6-nonafluorohexene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,6-nonafluorohexene

EC Number:

243-053-7

EC Name:

3,3,4,4,5,5,6,6,6-nonafluorohexene

Cas Number:

19430-93-4

Molecular formula:

C6H3F9

IUPAC Name:

3,3,4,4,5,5,6,6,6-nonafluorohex-1-ene

Constituent 2

Reference substance name:

3,3,3,4,4,5,5,6,6,6-Nonafluorohexene

IUPAC Name:

3,3,3,4,4,5,5,6,6,6-Nonafluorohexene

Test material form:

other: liquid

Details on test material:

Purity 99.0%
Impurities present:
3,3,3,4,4-pentafluoro-1-butene = 0.87%
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octene = 0.08%
1,1,1,2,2,3,3,4,4-nonafluoro-4-iodobutane = 0.004%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

3-days

Number of animals or in vitro replicates:

2

Details on study design:

0.1 ml of undiluted test material was placed into the right conjunctival sac of each of 2 male New Zealand White Rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed. Observations of the cornea, iris and conjunctiva were made with an ophthalmoscope at 1 and 4 hours, and at 1, 2 and 3-days. Fluor-I-strip® and a slit lamp biomicroscope were used at examinations after the day of treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Any other information on results incl. tables

Table 1: Results of PFBE Eye Irritation Test in the Rabbit

Dose	Treatment	Ocular Effects
		Cornea	Iris	Conjunctiva
0.1 ml	Not washed	General area of slight clouding at 1 hr; decreasing to a small area at 4 hr	No involvement	Redness:None Swelling:Slight 1 – 4 hr Discharge:Mild at 4 hr
0.1 ml	Washed	Small area of slight clouding at 1 hr decreasing to a local area 4 hr – 1 day	No involvement	Redness:None Swelling:Slight 1 – 4 hr Discharge:None

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) may produce slight to mild eye irritation.

Executive summary:

PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused slight corneal clouding and mild conjunctivitis in a treated rabbit eye. It caused slight corneal clouding and slight conjunctivitis in an eye, when treated and promptly washed. Both washed and unwashed eyes were normal 2 days after treatment.

PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) may produce slight to mild eye irritation.