Silver carbonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-11-02 to 1992-11-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Guideline study, however no information on test item purity and stability were stated. Minor deviation from the guideline: - a modified Draize scale was used. According to the Draize scale as stated in the guideline rating for conjunctival redness includes the cornea and iris. The cornea and iris were excluded in this study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1987-02-24

Deviations:

yes

Remarks:

, please refer to "Rationale for reliability incl. deficiencies" above

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 1992-06-11

Test material

Test material information

Constituent 1

Reference substance name:

Silver carbonate

EC Number:

208-590-3

EC Name:

Silver carbonate

Cas Number:

534-16-7

Molecular formula:

CH2O3.2Ag

IUPAC Name:

disilver(1+) carbonate

Details on test material:

- Name of test material (as cited in study report): silver carbonate
- Physical state: light green powder
- Storage condition of test material: grey plastic tub, room temperature

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: approximately 12 to 16 weeks
- Weight at study initiation: 3.10 kg
- Housing: the animal was individually housed in a suspended metal cage.
- Diet (ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K)
- Water(ad libitum): mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20
- Humidity (%): 64 - 66
- Air changes (per hr): approximately 15
- Photoperiod: 12 hours dark/light cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

For the purpose of this study the test material was used as supplied.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg test material 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. The left eye remained untreated and was used for control purposes.

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

approximately 1 and 24 hours following treatment

Number of animals or in vitro replicates:

1 male rabbit

Details on study design:

Immediately before the start of the test, both eyes of the provisionally selected test rabbit were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope.

SCORING SYSTEM: Immediately after administration of the test material, an assessment of the initial pain reaction was made. Assessment of ocular damage/irritation was made according to the Draize scale. Any other adverse ocular effects were also noted.

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:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Area of opacity: greater than three quarters, up to whole area; The effect was observed 1h after treatment.The animal was killed for humane reasons immediately after the 24-hour observation.

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Area of opacity: greater than three quarters, up to whole area

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: Effects observed 1 hour after treatment

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

not specified

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: Grey-coloured staining over the nictitating and lower conjunctival membranes; petechial haemorrhage of the nictitating and conjunctival membranes. Effects observed 1 hour after treatment.

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: White appearance of nictitating membrane. Haemorrhage of the nictitating membrane.

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Discharge with moistening of the lids and hairs a considerable area around the eye. Residual test material around treated eye. Effects observed 1 hour after treatment.

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Discharge with moistening of the lids and hairs a considerable area around the eye. Residual test material around treated eye.

Irritant / corrosive response data:

Residual test material was noted around the treated eye one and 24 hours after treatment.
Grey-coloured staining over the nictitating membrane and lower conjunctival membranes was noted in the treated eye one hour after treatment. This did not affect evaluation of ocular effects.
Areas of diffuse corneal opacity were noted in the treated eye one hour after treatment. Opaque corneal opacity over the lower half of the cornea with translucent to opalescent corneal opacity in the remaining area of the treated eye was noted at the 24-hour observation.
Iridial inflammation was noted in the treated eye one and 24 hours after treatment.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment with severe conjunctival irritation at the 24-hour observation. Petechial haemorrhage of the nictitating and conjunctival membranes was noted in the treated eye one hour after treatment. Haemorrhage and white appearance of the nicititating membrane were noted in the treated eye at the 24-hour observation with haemorrhage of the conjunctival membrane also noted at this time.
There was an initial pain reaction of 2.
The animal was killed for humane reasons immediately after the 24-hour observation in accordance with current U.K. Home Office guidelines. No further animals were treated.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Silver carbonate is considered to be at least a very severy irritant to the rabbit eye (class 7 on a 1-8 scale, according to a modified Kay and Calandra classification system. The test material produced positive criteria in the treated rabbit according to the EEC labelling regulations (EC-Commission directive 67/548/EEC) and was considered to be irritant to the rabbit eye. It is reasonable to assume the symbol "Xi" and highest risk phrase R41 "risk of serious damage to eyes" are required.
According to the EC-Regulation 1272/2008 and subsequent regulations, this results in a preacuationary classification Category 1, "Irreversible effects on the eye", with the hazard statement "H318: Causes serious eye damage".