Registration Dossier

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
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
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.