Registration Dossier
Registration Dossier
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EC number: 601-779-5 | CAS number: 121451-02-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 August 1999 - 27 August 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Primary Eye Irritation Study, 1985.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 601-779-5
- Cas Number:
- 121451-02-3
- Molecular formula:
- C17H7Cl2F9N2O3
- IUPAC Name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Substance type: White solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.6 - 2.7 kg
- Diet: 5 ounces of pelleted rodent feed per day.
- Water: Municipal water was provided ad libitum.
- Acclimation period: for at least two weeks prior to study start.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3 °C
- Humidity (%):40 – 60 %
- Air changes (per hr): 12-15 times/hour.
- Photoperiod (hrs dark / hrs light): 12-hour light/dark photocycle, lights on at 6:00 a.m. and off at 6:00 p.m.
IN-LIFE DATES: From: 01/05/1999 To: 27/08/1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g (in powdered form). - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three rabbits.
- Details on study design:
- APPLICATION
- Method: A 0.1 gram aliquot of XDE-007 in powder form was instilled into the conjunctival sac of the right eye of one male and two female rabbits. The eyelid of each rabbit was held closed for approximately one second after dosing.
- Control: The left eye remained untreated and served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of all rabbits remained unwashed post-treatment. See Table 1 for scoring system.
SCORING SYSTEM: Both eyes of the rabbits were examined at approximately 1, 24, 48 and 72 hours post-instillation for conjunctival redness and chemosis, discharge, corneal opacity and reddening of the iris.
TOOL USED TO ASSESS SCORE
Binocular loupe and a white halogen light.
BODY WEIGHT
Rabbits were weighed on the day of treatment and at study termination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- One hour after dosing, all rabbits had slight conjunctival redness, slight or moderate chemosis, and slight or moderate ocular discharge.
Twenty-four hours after dosing, two rabbits had slight conjunctival redness.
Forty-eight hours after dosing, the eyes of all rabbits were normal, and the study was terminated seventy-two hours after dosing. - Other effects:
- There was no effect of individual body weights.
Any other information on results incl. tables
Table 2: Individual Irritation Scores
Observation Time |
Animal No. |
Redness |
Conjunctivae Chemosis |
Discharge |
Corneal Opacity |
Reddening of Iris |
1 hour |
99A3944 |
1 |
1 |
1 |
0 |
0 |
99A3945 |
1 |
2 |
2 |
0 |
0 |
|
99A3946 |
1 |
1 |
1 |
0 |
0 |
|
24 Hours |
99A3944 |
0 |
0 |
0 |
0 |
0 |
99A3945 |
1 |
0 |
0 |
0 |
0 |
|
99A3946 |
1 |
0 |
0 |
0 |
0 |
|
48 Hours |
99A3944 |
0 |
0 |
0 |
0 |
0 |
99A3945 |
0 |
0 |
0 |
0 |
0 |
|
99A3946 |
0 |
0 |
0 |
0 |
0 |
|
72 hours |
99A3944 |
0 |
0 |
0 |
0 |
0 |
99A3945 |
0 |
0 |
0 |
0 |
0 |
|
99A3946 |
0 |
0 |
0 |
0 |
0 |
Table 3: Individual Body Weights
Animal Number |
Body Weight (kg) |
|
Test Day 1 |
Test Day 2 |
|
99A3944 |
2.600 |
2.622 |
99A3945 |
2.672 |
2.599 |
99A3946 |
2.684 |
2.662 |
Note: Animals 99A3945 and 99A3946 were females, 99A3944 was male.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material did not cause any adverse effects and is classified as not irritating.
- Executive summary:
The acute eye irritation potential of the test material was determined in a GLP study performed in accordance with the standardised guidelines OECD 405, EPA OPPTS 870.2400, EU Method B.5, and Japan MAFF Primary Eye Irritation Study, 1985.
Aliquots of 0.1 g of the test material were placed into the conjunctival sac of the right eye of three New Zealand White rabbits.
One hour after dosing, all rabbits had slight conjunctival redness, slight or moderate chemosis, and slight or moderate ocular discharge. Twenty-four hours after dosing, two rabbits had slight conjunctival redness. Forty-eight hours after dosing, the eyes of all rabbits were normal, and the study was terminated seventy-two hours after dosing. Instillation of XDE-007 in the eye had no effect on body weight.
Under the conditions of the test, the test material did not cause any adverse effects and is classified as not irritating.
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