DS-2920A-E

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 24 February 1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): DS-2920A-E
- Physical state: orange solid
- Analytical purity: no data
- Lot/batch No.: 004
- 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
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.63 - 2.79 kg
- Housing: individually in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 66 - 74. On one occasion the relative humidity was above the limit specified in the study protocol (70%). This deviation was considered not to affect the purpose or integrity of the study.
- Air changes (per hr): approximately 15 changes per hour
- 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:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material, which was found to weigh approximately 24 mg (as measured by gently compacting the required volume into an adapted syringe) 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 one second immediately after application, to prevent loss of the test material, and then released.

Duration of treatment / exposure:

One exposure, no washing out.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

One rabbit was initially treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not done

ASSESSMENT:
- Immediately after administration of the test material, an assessment of the initial pain reaction was made.
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

SCORING SYSTEM:
- According to the numerical evaluation given in Appendix I, (from Draize JH (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

other: no effects

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

- No corneal or iridial effects were noted.
- Minimal conjunctival irritation (score 1) was noted in all treated eyes at the 1-hour observation.
- No signs of ocular irritation were noted at the 24-hour observation.

Other effects:

The fur around all treated eyes was stained orange throughout the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU