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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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

Constituent 1
Chemical structure
Reference substance name:
Silver chloride
EC Number:
232-033-3
EC Name:
Silver chloride
Cas Number:
7783-90-6
Molecular formula:
AgCl
IUPAC Name:
silver(1+) chloride
Details on test material:
- Name of test material (as cited in study report): Silver chloride
- Physical state: white powder
- Storage condition of test material: the test substancce was kept at room temperature
- pH value: neutral

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 -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

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 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).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.