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EC number: 207-623-9 | CAS number: 485-72-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 February - 3 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone
- EC Number:
- 207-623-9
- EC Name:
- 7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone
- Cas Number:
- 485-72-3
- Molecular formula:
- C16H12O4
- IUPAC Name:
- 7-hydroxy-3-(4-methoxyphenyl)-4H-chromen-4-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Lot No. of test material: 07-170-FIL-2/3
- Appearance: White powder
- Expiration date: May 2010
- Purity: 98.4%
- Storage 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:
- TEST ANIMALS
- Source: Nichols Rabbitry Inc., Lumberton, TX
- Age at study initiation: Approx. 13 weeks old
- Weight at study initiation: Male: 2.7 kg; Females: 2.4 - 2.6 kg
- Housing: Suspended, wire bottom, stainless steel cage; 1 animal per cage
- Diet: PMI Feeds Inc. Lab Rabbit Diet #5321; 8 oz daily
- Water: Municipal water supply available ad libitum from automatic water system
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 12 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 11 February 2008 To: 14 February 2008
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL by volume equivalent to 57.8 mg of test material - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: All treated eyes were washed with room temperature deionised water for one minute immediately after recording the 24 hour observation.
- Time after start of exposure: 24 hours
OBSERVATIONS:
The treated eyes of all animals were examined without magnification under white room lighting provided by daylight-type fluorescent ceiling fixtures and (if needed) an additional source of white light affixed to the examination table or using a hand-held flashlight. The grades of ocular reaction were recorded at 1, 24, 48 and 72 hours after treatment. The corneas of all treated eyes were examined immediately after the 24 hour observation with a fluorescein sodium ophthalmic solution. Any of the corneas which exhibited fluorescein staining at the 24 hour observation were re-examined with the fluorescein sodium ophthalmic solution at each consecutive observation until fluorescein staining of the cornea no longer occurred.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein sodium ophthalmic solution and a Finoff ocular transilluminator with cobalt blue filter
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: All animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Rabbit No. 2300-M
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Rabbit No. 2295-F
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- Rabbit No.
- Time point:
- 24/48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- There were no positive effects observed during the study. No irritation was observed in any eyes at 72 hours.
- Other effects:
- - Other observations: Fluorescein staining did not occur in any of the eyes.
- Actual temperature: 18 - 22°C
- Actual relative humidity: 41 - 84% (Humidity was outside of the protocol range but did not affect the study outcome)
Any other information on results incl. tables
Table 1: Ocular reactions
|
Rabbit No. 2300-M |
Rabbit No. 2295-F |
Rabbit No. 2297-F |
|||||||||
|
Hours after treatment |
Hours after treatment |
Hours after treatment |
|||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
I. Cornea |
||||||||||||
A. Opacity |
0 |
0 |
0 |
0 |
+ |
0 |
0 |
0 |
+ |
0 |
0 |
0 |
B. Area |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
C. Fluorescein staining |
- |
0 |
- |
- |
- |
0 |
- |
- |
- |
0 |
- |
- |
D. Stippling |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
SCORE |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II. Iris |
||||||||||||
A. Grade |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
SCORE |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
||||||||||||
A. Redness |
1 |
1 |
0 |
0 |
1t |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C. Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
D. Necrosis or ulceration |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
SCORE |
2 |
2 |
0 |
0 |
2 |
2 |
0 |
0 |
2 |
2 |
2 |
0 |
TOTAL SCORE |
2 |
2 |
0 |
0 |
2 |
2 |
0 |
0 |
2 |
2 |
2 |
0 |
M – male
F – female
t – trace of test substance in eye
Duration of study: 72 hours
Table 2: Scores and score summary
Time after treatment |
Rabbit Number |
Average score |
||
2300-M |
2295-F |
2297-F |
||
Hour 1 |
2 |
2 |
2 |
2.0 |
Hour 24 |
2 |
2 |
2 |
2.0 |
Hour 48 |
0 |
0 |
2 |
0.7 |
Hour 72 |
0 |
0 |
0 |
0.0 |
Maximum average irritation score: |
2.0 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Formononetin is considered to be non-irritating to eyes.
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