Silver carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-10-20 to 1992-10-27

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 was stated. Deviation from the guideline:- the weights of the rabbits at the conclusion of the test were missing- description of any other toxic effects was not given

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 404 (Acute Dermal Irritation / Corrosion)

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.51 - 2.56 kg
- Housing: The animals were individually housed in suspended metal cages.
- 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): 16 - 20
- Humidity (%): 39 - 55
- Air changes (per hr): approximately 15
- Photoperiod: 12 hours dark/light cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quantity of 0.5 g of the test material, moistened with distilled water immediately before application, was applied.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water

Duration of treatment / exposure:

4 hours

Observation period:

approximately 1 hour following the removal of the patches, and 24,48 and 72 hours later and on day 7

Number of animals:

2 male rabbits / 1 female rabbit

Details on study design:

TEST SITE
- Area of exposure: on the day before the test each of a group of three rabbits was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with healthy intact epidermis by gross observation were selected for the study.
- Type of wrap if used: The test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM: The test sites were examined for evidence of primary irritation and scored according to the Draize scale. Any other adverse skin reactions, if present, were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

Faint yellow-coloured staining caused by the test material was noted at all treated skin sites following patch removal. This did not affect evaluation of skin responses. The faint yellow-coloured staining had disappeared by the end of the observation period.
Very slight erythema was noted at one treated skin site one hour after patch removal, at two treated skin sites at the 24 and 48-hour observations and at one treated skin site at the 72-hour observation. No adverse skin reactions were noted seven days after treatment.
No corrosive effects were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Silver carbonate is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as irritating to the skin.