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Registration Dossier
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EC number: 430-710-1 | CAS number: 15290-77-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1997-09-01 to 1997-09-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- Sep 27, 1985
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 430-710-1
- EC Name:
- -
- Cas Number:
- 15290-77-4
- Molecular formula:
- C5H3F7
- IUPAC Name:
- 1,1,2,2,3,3,4-heptafluorocyclopentane
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 9705-2A
Purity: 98.18 %
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Age at study initiation: 10 to 16 weeks
- Weight at study initiation: 2.4 to 3.6 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) SQC Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20.5
- Humidity (%): 57-75
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 4 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TREATMENT PROCEDURE
The eyes of each animal were examined prior to instillation to ensure that there was no pre-existing corneaI damage, iridial or conjunctival inflammation.
One animal was treated in advance of the other five, to ensure that if a severe response was produced, no further animals would be exposed. Approximately 0.1 mL of the test substance was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: handheld light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 & #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3 & #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed.
Diffuse beefy to crimson red colouration of the conjunctivae was seen in three animals at the one hour time point. Transient hyperaemia was observed in the remaining three animals. In addition, swelling was seen in two animals. These reactions had resolved in all instances by 1, 2 or 4 days after instillation. No corneal damage or irridial inflammation was observed - Other effects:
- - Clinical observations:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Ocular reactions:
No. |
Conjunctivae |
Chemosis |
Cornea opacity |
Iris |
||||||||||||
24h |
48h |
72h |
Mean |
24h |
48 h |
72 h |
Mean |
24h |
48h |
72 h |
Mean |
24h |
48h |
72 h |
Mean |
|
1 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- A single instillation of test item into the eye of the rabbit elicited transient, very slight to moderate conjunctivaI irritation.
- Executive summary:
A study was performed to assess the eye irritation potential of test item to the rabbit following EPA OTS 798.4500. Six rabbits were each administered a single ocular dose of 0.1 mL of the test substance and observed for up to four days after instillation.
There were no signs of toxicity or ill health in any rabbit during the observation period.
No corneal damage or iridial inflammation was observed.
Diffuse beefy to crimson red colouration of the conjunctivae was seen in three animals at the one hour time point. Transient hyperaemia was observed in the remaining three animals. In addition, swelling was seen in two animals. These reactions had resolved in all instances by 1, 2 or 4 days after instillation. No corneal damage or irridial inflammation was observed.
A single instillation of test item into the eye of the rabbit elicited transient, very slight to moderate conjunctivaI irritation.
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