Silver

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-08-04 to 1993-08-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: In principle well documented GLP-study, but no information on test item purity was provided.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Silver

EC Number:

231-131-3

EC Name:

Silver

Cas Number:

7440-22-4

Molecular formula:

Ag

IUPAC Name:

Silver

Details on test material:

- Name of test material (as cited in study report): silver powder CAP 9
- Physical state: grey powder
- Storage condition of test material: room temperature, white plastic container
- Particle size: <40 µm

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, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.2 - 2.52 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: ad libitum (RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 62 - 68
- Air changes (per hr): 15
- Photoperiod: 12 hours dark/light cycle

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): 100 mg of the test material was placed into the conjunctival sac of the right eye.

Duration of treatment / exposure:

1 second

Observation period (in vivo):

Immediately after administartion of the test material, an assessment of the initial pain reaction was made.

Number of animals or in vitro replicates:

3 rabbits: After consideration of the ocular response produced in the first treated animal, two additional animals were treated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
no data

SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation from DRAIZE 1959.

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: Cornea opacity score

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

1

Reversibility:

not specified

Remarks on result:

other: redness

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: Conjunctivae chemosis score

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.
No ocular effects were noted 24, 48 or 72 hours after treatment.

Other effects:

Residual test material was noted around the treated eye of all animals during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

The test material was classified as non-irritant according to EEC labelling regulations.