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EC number: 203-120-3 | CAS number: 103-53-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Mar - 16 Mar 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Feb. 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Jan 1997
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenethyl cinnamate
- EC Number:
- 203-120-3
- EC Name:
- Phenethyl cinnamate
- Cas Number:
- 103-53-7
- Molecular formula:
- C17H16O2
- IUPAC Name:
- phenethyl cinnamate
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
- Weight of animals: 1.7 — 1.8 kg b.w.
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe; ad libitum.
- Water: ad libitum; domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C
- Humidity: 55% ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): cycle of 12 hours light and 12 hours darkness. Light was on from 6 a.m. to 6 p.m.
DATES:
The experimental work was carried out between 12.03.2001 and 16.03.2001.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Single dose, not rinsed until after the 24h examination.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- TEST PROCEDURE
0.1g of the test article was placed in one eye of the rabbit, in the cup that formed by gently pulling the lower lid away from the eyeball.
The lids were then gently held together for 1 second.
OBSERVATIONS:
- Observations after 1h, 24h, 48h and 72h
- Additionnally, after the 24h reading, Fluorescein was instlled. The eye was rinsed with 20 mL 0.9% sodium chioride solution and examined again using UV light
SCORING SYSTEM:
See 'Any other information on materials and methods'
TOOL USED TO ASSESS SCORE: fluorescein-UV-light (after 24h).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility
- Remarks:
- not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility
- Remarks:
- not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility
- Remarks:
- not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility
- Remarks:
- not applicable
- Irritant / corrosive response data:
- One hour after application of the test article animals No. 2085 and No. 2083 showed a diffuse, crimson red conjunctiva with individual vessels not easily discernbile, a swelling above normal and a discharge different from normal. Some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal were observed in animals No. 2084 and No. 2072.
24 hours after application of the test article animal No. 2085 showed some conjunctival vessels definitely injected. Some conjunctival vessels definitely injected and a swelling above normal were observed in animal No. 2083. Animals No. 2084 and No. 2072 were free of any signs of eye irritation.
48 and 72 hours after application of the test article all four animals, No. 2085, No. 2083, No. 2084 and No. 2072, were free of any signs of eye irritation.
Any other information on results incl. tables
Scores for ocular lesions:
*individual mean score: Only the scores from the readings after 24, 48 and 72 hours are included in the calculation of the individual mean scores.
| Rabbit No/Weight per kg | Parameters | Individual mean score* |
| 2085/1.7 | cornea opacity | 0.00 |
| iris | 0.00 | |
| conjunctiva redness | 0.33 | |
| conjunctiva chemosis | 0.00 | |
| 2083/1.8 | cornea opacity | 0.00 |
| iris | 0.00 | |
| conjunctiva redness | 0.33 | |
| conjunctiva chemosis | 0.33 | |
| 2084/1.7 | cornea opacity | 0.00 |
| iris | 0.00 | |
| conjunctiva redness | 0.00 | |
| conjunctiva chemosis | 0.00 | |
| 2072/1.7 | cornea opacity | 0.00 |
| iris | 0.00 | |
| conjunctiva redness | 0.00 | |
| conjunctiva chemosis | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The test item shall not be classified as eye irritating.
- Executive summary:
In the current test the eye irritant effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405 and EEC Guideline B.5. The study was performed in accordance with GLP.
Four female albino rabbits were exposed to 0.1 g of the test article in one eye, while the other eye remained untreated and served as control. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing.
Slight to well-defined signs of irritation were observed on the treated eyes. However, 48 and 72 hours after application of the test article all four animals were free of any signs of eye irritation.
Based on these results, the substance was concluded to be not irritating to the eye.
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