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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:
The study was performed between 30 April 2012 and 11 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (z)-hex-3-enyl acetate (LEAC)
- Physical state: clear colourless liquid
- Analytical purity: 98.45 %
- Lot/batch No.: 1Z00151
- Expiration date of the lot/batch: 13 June 2015
- Stability under test conditions: room temperature in the dark under nitrogen
- Storage condition of test material:
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Leicestershire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.45 or 2.94 kg
- Housing: the animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a lvel that might have affected the purpose or integrity of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
Immediately and 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
2
Details on study design:
PROCEDURE
Initially, a single rabbit was treated. A volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about 1 sec immediately after treatment, to prevent loss of the test item, and then released. Immediately after administration of the test item, an assessment of the initial pain reaction was made.

After consideration of the ocular responses produced in the first treated animal, a second animal was treated.

Any other ocular effects were also noted. Any clinical signs of toxicity, if present, were also recorded. Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.


SCORING SYSTEM: Draize scale (see Appendix 2 attached). If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean score for all animals
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
iris score
Basis:
other: mean score for all animals
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean score for animal 1
Time point:
other: 24, 48, 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean score for animal 2
Time point:
other: 24, 48, 72 h
Score:
0.67
Irritation parameter:
chemosis score
Basis:
other: mean score for animal 1
Time point:
other: 24, 48, 72 h
Score:
0.67
Irritation parameter:
chemosis score
Basis:
other: mean score for animal 2
Time point:
other: 24, 48, 72 h
Score:
0.33
Irritant / corrosive response data:
No corneal effects were noted during the study.

Iridial inflammation was noted in 1 treated eye 1 h after treatment.

Moderate conjunctival irritation was noted in both treated eyes 1 h after treatment. Moderate conjunctival irritation persisted in 1 treated eye with minimal conjunctival irritation noted in the other treated eye at the 24-Hour observation. Minimal conjunctival irritation was noted in both treated eyes at the 48-Hour observation.

Both treated eyes appeared normal at the 72-Hour observation.
Other effects:
Bodyweight: both animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Individual scores and individual total scores for ocular irritation

Rabbit number and sex

71969 Male

71992 Male

IPR= 2

IPR= 2

Time after treatment

1 Hour

24 Hours

48 Hours

72 Hours

1 Hour

24 Hours

48 Hours

72 Hours

CORNEA

E= Degree of opacity

0

0

0

0

0

0

0

0

F= Area of cornea involved

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

IRIS

D

1

0

0

0

0

0

0

0

Score (D x 5)

5

0

0

0

0

0

0

0

CONJUNCTIVAE

A= Redness

2

2

1

0

2

1

1

0

B= Chemosis

2

1

1

0

1

1

0

0

C= Discharge

2

1

0

0

1

0

0

0

Score (A + B + C) x 2

12

8

4

0

8

4

2

0

Total score

17

8

4

0

8

4

2

0

 IPR= initial pain reaction

Individual total scores and group mean scores for ocular irritation

Rabbit number and sex

Individual total scores at:

1 Hour

24 Hours

48 Hours

72 Hours

71969 Male

17

8

4

0

71992 Male

8

4

2

0

Group total

25

12

6

0

Group mean score

12.5

6.0

3.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was assessed for acute eye irritation according to OECD guideline 405. The test item is classified as not irritating although it was found to be a mild irritant under the conditions of this study according to a modified Kay and Calandra classification system.