Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 May 1990 - 26 May 1990
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Internal, similar to OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromoheptadecafluorooctane
EC Number:
207-028-4
EC Name:
1-bromoheptadecafluorooctane
Cas Number:
423-55-2
Molecular formula:
C8BrF17
IUPAC Name:
1-bromo-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane
Test material form:
liquid
Specific details on test material used for the study:
Physical state/Appearance: Clear colourless liquidStorage 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:
Age of animals at study initiation: AdultWeight at study initiation: 2.0 -3.5 kgAcclimation period: At least 7 days Environmental controls for the animal room was set to maintain a temperature of 70 deg F ±3 deg F, a relative humidity of 50% ±20%, and a 12-hour light/12-hour dark cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye on the animal served as control
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male and 3 female
Details on study design:
Each rabbit received 0.1 mL of the test material placed into the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The upper and lower lids were gently held together for one second to prevent loss of material and then released. The eyes of the rabbits remained unflushed.The treated eyes were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment. At the 72 -hour reading, sodium fluorescein was used to aid in revealing possible corneal injury. Irritation was graded and scored according to the Draize technique.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Irritant / corrosive response data:
No signs of eye irritation were noted in any of the animals. No pain response was elicited from any animal following instillation of the test material.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material, Imagent GI (PFOB), produced no ocular irritation when instilled into the eyes of six albino rabbits.