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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 July 2014 to 24 July 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as an unpublished report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Silver cyanide
EC Number:
208-048-6
EC Name:
Silver cyanide
Cas Number:
506-64-9
Molecular formula:
CAgN
IUPAC Name:
silver(1+) cyanide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: silver cyanide
- Substance type: white powder
- Physical state: solid
- Stability under test conditions: At least 2 years, if stored correctly.
- Storage condition of test material: At room temperature in a tightly closed container.

Test animals

Species:
rat
Strain:
other: CD : Crl CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles river Laboratories, Research Models and Services, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 230 - 281 g (males), 222 - 250 g (females)
- Fasting period before study: Yes, approximetely 16 hours before test item administration.
- Housing: Rats kept individually in MAKROLON cages (type III plus), with granulated textured wood (Granulat A2, J. Brandenburg, Germany) used as bedding material.
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, German)
- Water (e.g. ad libitum): tap water offered ad libitum
- Acclimation period:At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light):12 h light / 12 h dark (about 150 lux at approx. 1.50 m room height)

IN-LIFE DATES: From: 17 July 2014 To: 24 July 2014

Administration / exposure

Vehicle:
water
Remarks:
Aqua ad iniectabilia
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 6 cm
- % coverage: approx. 10 % of body surface
- Type of wrap if used: The test item was applied to 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster on the application site.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg b.w. of the paste (test item-vehicle preparation) (based on the weight)
- Concentration (if solution): 2000 mg/kg b.w.
- Constant volume or concentration used: No
- For solids, paste formed: yes, 10 g test item was mixed with 5 g water in a mortar to obtain a paste.
Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w. (limit test)
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration.
- Necropsy of survivors performed: yes
- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day.Observations on mortality were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LDLo
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortalities observed.
Clinical signs:
other: None.
Gross pathology:
None.
Other findings:
None.

Any other information on results incl. tables

Table 1. Summary of the results

Symptoms/criteria

Silver cyanide 2000 mg/kg b.w. (n=5)

males

females

Clinical signs

None

None

Skin reaction

None

None

Mortality within 6 h

0

0

24 h

0

0

7 d

0

0

14 d

0

0

Mean bodyweight (g) start

257.8

230.6

After 7 d

303.8 (+17.8)

236.4 (+2.5)

After 14 d

364.0 (+41.2)

255.8 (+10.9)

Inhibition of bodyweight gain

None

None

Necropsy findings

None

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Silver cyanide requires no labelling according to the EC directive 67/548/EEC. According to the EC Regulation 1272/2008 and Globally Harmonized Classification System (GHS), the test material is not classified for acute dermal toxicity.


Executive summary:

Introduction

Silver cyanide was examined for acute toxicity after a single dermal application to rats. The study was conducted according to OECD 402 and EC method B.3.

Materials and methods

Silver cyanide was applied once for 24 hours on the shaved intact dorsal skin of rats. One dose level of 2000 mg/kg b.w. was used.

The treatment was followed by an observation period of 2 weeks.

Results

Under the present test conditions, a single dermal administration of 2000 mg silver cyanide/kg b.w. did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected weight throughout the whole experimental period. No macroscopic findings were observed at necropsy.