Disilver(1+) sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-10-09 to 1990-10-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline study. At the time of the study conduct, GLP was not compulsory . However, the study was conducted in accordance with the principles of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981-05-12

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disilver(1+) sulphate

EC Number:

233-653-7

EC Name:

Disilver(1+) sulphate

Cas Number:

10294-26-5

Molecular formula:

Ag.1/2H2O4S

IUPAC Name:

disilver(1+) sulfate

Details on test material:

- Name of test material (as cited in study report): silver (I) sulphate
- Physical state: white, crystalline powder
- Storage condition of test material: closed container at room temperature, protected against light
- pH value: approx. 7

Test animals

Species:

rabbit

Strain:

other: white russian (albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-9 months
- Weight at study initiation: 2.54-2.80 kg
- Housing: stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH), supplied by ASTA Pharma AG, 4800 Bielefeld, Germany; individually housing
- Diet: approx. 120 g/day x animal standard diet, ssniff K, special diet for rabbits, supplied ny ssniff Spezialfutter GmbH, 4770 Soest, Germany
- Water: ad lipidium; drinking water quality from the Stadtwerke Bielefeld
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 24.0
- Humidity (%): 40 - 70
- Photoperiod: 12 hours dark/light cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item was given to the dorsal skin area.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.14 mL demineralised water per 0.5 g test material.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the patches, thereafter once daily: 2 animals were observed for 3 days after application and in 1 animal for 5 days after application.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: the application sites were clipped free of hair one day before treatment.Test substance was placed on the shorn dorsal skin area between shoulder and sacrum.
- Type of wrap if used: The site of application was covered with a linen cloth (approx. 6.25 cm2) which adhered to a synthetic film glue. A bandage
wrapped several times around the trunk (Acrylastic, No. 2408, width 8 cm; supplied by P. Beiersdorf and Co. AG, Hamburg) provided a complete occlusion.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the end of the exposition time remaining test material was gently washed off as far as possible.

SCORING SYSTEM: The treated skin area was assessed qualitatively (erythema/eschar resp. edema) and quantitatively (values 0-4) using the DRAIZE scale. In addition, attention was paid to the occurrence of further reactions on the skin (e.g. corrosive effects) and to clinical symptoms (systemic toxic effects).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

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:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

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:

The single application of 0.5 g silver(I) sulphate to the intact skin of three rabbits each caused only very slight changes.
A very slight erythema (grade 1) occurred in one animal only 48 hours after application and in another animal from 24 hours after application until day 4.
A very slight oedema (grade 1) was observed in one animal only 2 days after application, 24 hours later the finding had completely disappeared.
In addition, the treated skin areas of all three animals were brownish discoloured during the whole observation period.
The control sites did not show any reactions.

Other effects:

Systemic toxic effects did not occur after dermal application of the test substance. The general conditions of the test animals was not affected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Silver (I) sulphate is not irritating to the skin, according to EC-Regulation 1272/2008.