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EC number: 442-300-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 24 February 1987)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Limited P.O. Box No. 45 DERBY DEI2BT U.K.
Test material
- Reference substance name:
- -
- EC Number:
- 442-300-8
- EC Name:
- -
- IUPAC Name:
- 2-(2-hydroxyethoxy)ethyl 2-oxo-2-phenylacetate; 2-{2-[(2-oxo-2-phenylacetyl)oxy]ethoxy}ethyl 2-oxo-2-phenylacetate
- Details on test material:
- - State of aggregation: liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum; certified Rabbit Diet (Code 5322) supplied by PMI Nutrition International, Nottingham, UK
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: unchanged - Duration of treatment / exposure:
- single instillation, eyes not washed out
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males.
Initially, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study. Conjunctival Discharge observed in all three animals after 1 hour. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment. All treated eyes appeared normal at the 24-hour observation.
Any other information on results incl. tables
Individual Scores
| Rabbit Number and sex | 81 male | 121 male | 34 male | |||||||||
| IPR = 2 | IPR = 2 | IPR = 3 | ||||||||||
| Time after treatment (h) | 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 |
| Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Conjunctival redness | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Discharge | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
IPR = Initial Pain reaction
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced mean scores (24 - 72 hours) of 0 in all animals for all parameters and did therefore not meet the criteria for GHS classification as irritant.
- Executive summary:
An acute eye irritation study according to OECD guideline 405 and in compliance with GLP was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation. The test material produced mean scores (24 - 72 hours) of 0 in all animals for all parameters and was classified as not irritating based on GHS and EU labeling regulations.
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