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Toxicological information

Eye irritation

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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:
2001
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

Constituent 1
Chemical structure
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

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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