Silver chloride

Endpoint summary

Description of key information

Zechel et al. 1989 studied, under GLP principles, the skin and eye irritation properties of silver chloride according to OECD 404 and 405 
respectively. They concluded that silver chloride is not irritating or corrosive to skin or eyes.
These findings are supported by Collier et al. 1981 and 1982 confirming the not irritating properties of silver chloride for skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-01-31 to 1989-02-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP guideline study reliable without restrictions- the stability of the test substance was missing.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981-05-12

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: white russian (albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 -11 months
- Weight at study initiation: 2.90 - 2.98 kg
- Housing: stainless steel cages with grating floor, type ASTA, size : 48.5 X 40 X 36.5 cm (LxBxH) ASTA Pharma AG, D-4800 Bielefeld 14, Germany; individually housed
- Diet: approx. 120 gram/day x animal, Standard diet, ssniff K, "Special Diet for Rabbits"; supplied by ssniff Spezialfutter GmbH, D-4770 Soest, germany
- Water (ad libitum): drinking water quality from the Stadtwereke Bielefeld (Municipal Works)
- Acclimation period: 1 day under test conditions before application of the product; veterinary supervision of the animals was done before start of study

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 22 °C
- Relative humidity: 45 - 60 %
- Photoperiod: (hrs dark / hrs light): 12/12

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 gram of the test substance were moistened with demineralized water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.15 mL demineralized water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the patches (duration of the observation period: 3 days p. appl.)

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure and type of wrap if used: the application sites were clipped free of hair 1 day before treatment.
To avoid deprivation, the test substance was moistened with the vehicle and placed on the shorn dorsal skin area between shoulder and sacrum. The site of application was covered with a linen cloth (approx. 6.25 cm^2) which adhered to a synthetic film glue. The opposite area of the dorsal skin was treated in the same way but without test substance (control site). A bandage wrapped several times around the trunk (Acrylastic, No. 2408, width 8 cm; 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 qualitatively (erythema / eschar resp. oedema) and quantitaively assessed using the Draize scale. In addition, attention was paid to the occurrence of further reactions on the skin (e.g. corrosive effect) and to clinical symptoms (systemic toxic effects).

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

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 gram silver chloride to the intact skins of three rabbits caused no changes.
Neither erythema nor oedema could be detected.
The areas not treated with the test substance did not show any reactions.

Other effects:

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

- Source of test animals: ASTA Pharma AG, D-4800 Bielefeld 14 , Germany

Interpretation of results:

GHS criteria not met

Remarks:

Silver chloride is not irritating to the skin.

Conclusions:

Silver chloride 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-04-18 to 1989-04-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1987-02-24

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: white russian (albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 months
- Weight at study initiation: 2.23 - 2.66 kg
- Housing: stainless steel cages with grating floor, type ASTA, size: 48.5X40X36.5 cm (LxBxH), ASTA Pharma AG, D-4800 Bielefeld 14; individually housed
- Diet: approx. 120 gram/day x animal, Standard Diet ssniff K, "Special diet for rabbits" supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (ad libitum): srinking quality from the Stadtwerke Bielefeld (Municipal Works)
- Acclimation period: the animals were kept one day under test conditions before application of the product. Veterinary supervision of the animals was done before start of study.

Preliminary inspection of the eye: 24 hours before application of the test substance.

ENVIRONMENTAL CONDITIONS
- Temperature: 20.5 - 23.5 °C
- Relative humidity: 45 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 gram of the test substance were applied into the conjunctival sac of the left eye. Then both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control.

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

1, 24, 48 and 72 hours p. appl., thereafter once daily 8duration of the observation period: 6 days p. appl.)

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed.

SCORING SYSTEM: signs of irritation on the cornea, iris and conjunctiva were assessed quantitatively and qualitatively using the Draize scale. In addition, attention was paid to the occurrence of further reactions on the eye (e.g. corrosive effect) and to clinical symptoms (systemic toxic effects).

TOOL USED TO ASSESS SCORE: the treated eye was examined using a Cliptrix pencil light (supplied by Varta, Hannover, No. 645).

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 5 days

Remarks on result:

other: Discharge: amount different from normal at 1 and 24 hour observation.

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Discharge: amount different from normal at 1 hour observation.

Irritation parameter:

chemosis 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 0.1 gram silver chloride into one conjunctival sac each of three rabbits caused only slight changes on the conjunctiva.
The cornea and the iris were without any findings.
The conjunctiva of all animals reacted with hyperemia (grade 1) during the first observation day. Only in one rabbit the finding lasted up to day 5 of observation.
Slight discharge (grade 1) occurred in two animals on the first day of observation.
The untreated eyes did not show any changes.

Other effects:

There were no systemic toxic effects after conjunctival application of the test substance.

Interpretation of results:

GHS criteria not met

Remarks:

Silver chloride is not irritating to the eyes.

Conclusions:

Silver chloride is not irritating to the eyes.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as irritating to the eyes.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as irritating to the eyes.
A pdf document including the calculation of mean irritation scores according to both guidelines is attached to this endpoint study record (please refer to "Attached background material" above).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Two reliable, guideline conform studies (OECD 404/405), documented under GLP principles, are available for silver chloride for skin and eye irritation/corrosion, respectively. All studies provide unequivocal negative results, i.e. showing that AgCl is not irritating or corrosive to skin or eyes. No hazard classification for these end-points is needed for AgCl.