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EC number: 205-031-5 | CAS number: 131-57-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Oxybenzone
- EC Number:
- 205-031-5
- EC Name:
- Oxybenzone
- Cas Number:
- 131-57-7
- Molecular formula:
- C14H12O3
- IUPAC Name:
- 2-benzoyl-5-methoxyphenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Animal strain in detail: Chbb:NZW
- Age at study initiation: approx. 9-13 weeks old
- Weight at study initiation: 2290 to 2490 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (32 mg) was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize system
- Scoring time: The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test item
TOOL USED TO ASSESS SCORE: slit lamp
OTHER:
- The animals were checked daily for systemic symptoms and mortality.
- Bodyweight was recorded at study initiation and on days 3 and 7 of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight conjunctivae redness (grade 1) seen at reading time points 1 hour up to 72 hours in 2/3 animals was reversible within 7 days after application. The average score (24, 48 and 72 hours) for irritation was calculated to be 1.0 (for conjunctivae redness). Slight, reversible conjunctivae redness (grade 1) was noted in the third animal 1 hour to 48 hours after application, fully reversible within 72 hours. Chemosis (grade 1) was observed in 3/3 animals one hour after treatment, only.
- Other effects:
- No other findings were observed.
Any other information on results incl. tables
Table 1. Results of eye irritation study.
Rabbit #
|
Time |
conjunctivae |
iris |
cornea |
|
redness |
chemosis |
||||
1
|
1 h |
1 |
1 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
1.0 |
0.0 |
0.0 |
0.0 |
|
2
|
1 |
1 |
1 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
0.0 |
0.0 |
0.0 |
0.0 |
|
3
|
1 |
1 |
1 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
|
average over 24, 48 and 72 h |
0.67 |
0.0 |
0.0 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oxybenzone was found to be slightly irritating to rabbit eyes, fully reversible within 7 days, in this test but does not require classification according to CLP and/or DSD.
- Executive summary:
Slight conjunctivae redness (grade 1) observed at reading time points 1 hour up to 72 hours in 2/3 animals was reversible within 7 days after application. The average score (24, 48 and 72 hours) for irritation was calculated to be 1.0 (for conjunctivae redness). Slight, reversible conjunctivae redness(grade 1) was noted in the third animal 1 to 48 hours after application.Therefore, average score (24, 48 and 72 hours) for irritation was calculated to be 0.67 (for conjunctivae redness) for this animal. For corneal opacity, iris and chemosis the average score (24, 48 and 72 hours) for irritation was calculated to be 0.0.The eye irritation study is acceptable (reliability 1), and does satisfy the guideline requirements for an eye irritation test (OECD 405) in rabbits.
Under the experimental conditions chosen, the test substance was considered to be not irritating to the eye of rabbits.Therefore, the test item is not warranted to be classified according to the EU Directive 67/548/EC and according to the CLP Regulation 1272/2008.
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