Hydroxyl-2-pyridone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 9-April 15, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EPA/FIFRA Pesticide Assessment Guidelines, Subdivision D - Product Chemistry

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxyl-2-pyridone

EC Number:

212-506-0

EC Name:

Hydroxyl-2-pyridone

Cas Number:

822-89-9

Molecular formula:

C5H5NO2

IUPAC Name:

1-hydroxy-1,2-dihydropyridin-2-one

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study reports): Oxy PYRION
- Physical state: solid (powder)
- Appearance: white speckled gold powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 93100020

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: approximately 3 months
- Weight at study initiation: 3.12 kg
- Housing: Suspended stainless steel cage mounted in a mobile battery. The cage was fitted with a perforated counter-sunk floor pannel. A tray beneath the floor was lined with absorbent paper which was changed regularly. Single animal in cage.
- Diet (e.g. ad libitum): STANRAB pelleted rabbit diet, ad libitum.
- Water (e.g. ad libitum): Standard tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C (range 15-23°C)
- Humidity (%): 55% (range 40-70%)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12 dark/12 light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1 instillation, the dose was instilled into the right eye by pulling the lower eyelid away from the eyeball to form a cup into which 0.1 g of the test material was dropped. The eyelid was gently held together for one second and then released.

Observation period (in vivo):

5 days
The behaviour of the rabbit was observed for several minutes immediately following instillation of the test material to allow assessment of the initial pain response

Number of animals or in vitro replicates:

1, because of the severe response observed in the sentinel animal, no further rabbits were committed to this study.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: 0-4 per Guideline

TOOL USED TO ASSESS SCORE:
An ophthalmoscope or a pencil beam torch was used to facility inspection of the eye.
The presence of corneal lesions was confirmed by fluorescein treatment. One drop of Fluorescein Sodium B.P. (Smith and Nephew Limited) was dorpped directly onto the cornea. The rabbit was allowed to blink before excess fluorescein was flushed out of the eye with physiological saline. Corneal damage was confirmed by distinctive yellow colouration of any injured areas when viewed under ultra-violet illumination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 5 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 5 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 5 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 5 days

Irritant / corrosive response data:

A diffuse beefy-red conjunctival appearance and iritis were observed during the first 72 hours following instillation of the test material. Slight to moderate discharge (with mucus), very slight to moderate chemosis and translucent or nacreous areas of opacity covering up to the whole area of the corneal surface were observed during this time. A white area was also observed on the lower bulbar conjunctiva at the 48 and 72 hour observations and continued to day 5. On day 5, nacreous opacity, iritis, slight chemosis, moderate discharge (with mucus) and a beefy-red conjunctival appearance were apparent. Additionally, areas of haemorrhage were seen on the nictitating membrane.

Other effects:

The animal was killed immediately after the day 5 examination, and no further animals were committed to the study.
Instillation of the test material caused a moderate initial pain response.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the conditions of the test, the test substance was considered to present risk of serious damage to the eyes.