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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:
19 September 2012 to 04 October 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 2-phenoxyethyl isobutyrate
- Physical state: clear colourless liquid
- 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
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: 2.98 to 3.42 kg
- Housing: Individually housed in suspended cages
- Diet: 2930C Teklad Global Certified Rabbit diet ad libitum
- Water: Mains tap water, ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Humidity: 30-70%
- Air changes: At least fifteen changes per hour
- Photoperiod: 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Administration of the test material: A single treatment was administered to initially one rabbit. 0.1 mL of the test material was instilled into the conjunctival sac of the right eye. The eyelids were held together for a second to prevent loss of the test material. The left eye remained untreated as a control. Based on the initial pain reaction, the second rabbit was treated using the same procedure as the first animal after the administration of a local anaesthetic instilled into both eyes of the second rabbit.
Duration of treatment / exposure:
A single treatment was administered, no washing was performed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
Draize Scale for Scoring Ocular Irritation

TOOL USED TO ASSESS SCORE: Standard ophthalmoscope

OTHER:
- pH: Prior to the commencement of the study, the pH of the test material was determined undiluted and as a 90 % aqueous preparation. The pH of the test material was determined to be approximately pH 7 undiluted, and approximately pH 6 as a 90 % aqueous preparation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 72444
Time point:
other: 24 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal: 72515
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No corneal or iridial effects were noted in either animal at any of the time points during the study. Both animals had minimal conjunctival irritation at one hour post treatment. This had completely cleared in one animal by the 24 hour observation time, minimal irritation was still noted in the other animal at the 24 hour observation time, but had resolved by 48 hours.
Other effects:
Both animals employed in the study demonstrated expected bodyweight gain during the course of the study.

Any other information on results incl. tables

Table 2: Individual irritation scores

Rabbit Number and Sex

72444 Male

72515 Male

Initial Pain Reaction

3

0+

Time After Treatment

(hours)

1

24

48

72

1

24

48

72

Cornea

0

0

0

0

0

0

0

0

Degree of opacity

0

0

0

0

0

0

0

0

Area of Cornea Involved

0

0

0

0

0

0

0

0

Iris

0

0

0

0

0

0

0

0

Conjunctivae

0

0

0

0

0

0

0

0

Redness

1

1

0

0

1

0

0

0

Chemosis

1

0

0

0

1

0

0

0

Discharge

0

0

0

0

0

0

0

0

+ Local anaesthetic (one drop of 0.5 % Tetracaine hydrochloride)

 

Table 3: Bodyweights and bodyweight changes

Rabbit Number and Sex

Individual Bodyweight (kg)

Bodyweight Change (kg)

Day 0

Day 3

72444 Male

3.42

3.5

0.08

72515 Male

2.98

3.03

0.05

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material induce only minimal reversible irritation during the test in the New Zealand White rabbit. The test material was therefore considered to be not irritating.
Executive summary:

The irritancy potential of the test material to the eye of the New Zealand White rabbit was evaluated in a GLP compliant study designed to be compatible with OECD 405 and EU Method B.5. Undiluted test material (0.1 mL) was instilled into the eye of two rabbits. After the initial pain reaction of the first rabbit, the test in the second rabbit was performed with a local anaesthetic. The rabbits were observed at 1, 24, 48 and 72 hours for signs of ocular irritation. Minimal conjunctival irritation was noted in both animals an hour post-instillation. One treated eye appeared normal at the 24 hour observation, and the other appeared normal at the 48 hour observation. Under the conditions of the test, the test material is considered to be non-irritating to the New Zealand White rabbit eye.