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Registration Dossier
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EC number: 201-061-8 | CAS number: 77-83-8
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-03-27 to 2000-04-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- No certificate
Test material
- Reference substance name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- EC Number:
- 201-061-8
- EC Name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- Cas Number:
- 77-83-8
- Molecular formula:
- C₁₂H₁₄O₃
- IUPAC Name:
- ethyl 3-methyl-3-phenyloxirane-2-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): Aldehyde C16 so-called; ethyl-2,3-epoxy-2-methyl-3-phenylpropionate-3-methyl-3-phenyloxiranecarboxylic acid ethyl ester.
- Substance type: Colourless to slight yellowish liquid
- Physical state: Liquid
- Analytical purity: Not specified but described as undiluted.
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Batch No: 50530043
- Expiration date of the batch: 300 days
- Stability under test conditions: 300 days
- Storage condition of test material: Cool and dry
- Other: Information supplied by sponsor
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Chbb:HM(SPF) Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach, Baden-Württemberg, Germany
- Age at study initiation: No data
- Weight at study initiation: 2.3 kg to 2.6 kg body weight
- Housing: Individually in PPO cages (floor area: 2576 cm²)
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 °C
- Humidity (%): 55 % ± 15 %
- Air changes: 10 times per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Volume applied: 0.1 mL - Duration of treatment / exposure:
- 24 hr
- Observation period (in vivo):
- 72 hr (observations at 1 hr, 24 hr, 48 hr, 72 hr)
- Number of animals or in vitro replicates:
- 4 female
- Details on study design:
- APPLICATION
- Test material applied by pulling lower eyelid away from the eye to form a cup into which the test material was dropped.
- Test material applied to left eye (right eye served as control)
- After application, eyelids held together gently for 1 s.
ASSESSMENT:
- Day prior to the beginning of testing, both eyes were examined with a hand-held inspection lamp fitted with a white and UV-light and magnifying glass with a 2 × magnification to ensure no prior defects or irritation.
- Fluorescein added after the first 24hr reading. After rinsing with 20 mL 0.9 % sodium chloride solution the eyes were examined again using UV light to detect possible corneal damage.
- Scoring system: Standard Draize system.
SENTINEL
Rabbit 1724 was used as a sentinel.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1274
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 1274
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1274
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1274
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1664
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 1664
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1664
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1664
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1665
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 1665
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1665
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1665
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1666
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 1666
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1666
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1666
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
Any other information on results incl. tables
Observations at 1 hr:
| Animal | Response |
| 1724 | Diffuse, crimson red conjunctiva with individual vessels not easily discernible, swelling above normal, discharge different from normal. |
| 1664 | Some conjunctival vessels definitely injected, swelling above normal, discharge with moistening of the lids and hairs just adjacent to lids. |
| 1665 | Some conjunctival vessels definitely injected, swelling above normal, discharge different from normal. |
| 1666 | Diffuse, crimson red conjunctiva with individual vessels not easily discernible, swelling above normal, a discharge with moistening of the lids and hairs just adjacent to the lids. |
Observations at 24 hr:
| Animal | Response |
| 1724 | Some conjunctival vessels definitely injected, swelling above normal |
| 1664 | Some conjunctival vessels definitely injected, swelling above normal |
| 1665 | Some conjunctival vessels definitely injected |
| 1666 | Some conjunctival vessels definitely injected, swelling above normal |
At 48 hr and 72 hr all animals were free of any signs of eye irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was found not to be irritating in an OECD 405 study.
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