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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 March 2014 to 25 April 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other: GLP compliant, guideline study, available as an unpublished report.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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Limit test:
no

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
- CAS number: 506-64-9
- Substance type: White powder
- Physical state: Solid
- Date of manufacture: June 2013
- Stability under test conditions: Stable under standard conditions.
- Storage condition of test material: Store in room temperature in a tightly closed container.

Test animals

Species:
rat
Strain:
other: CD/Crl: CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, DE
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 175 - 192 g
- Fasting period before study: 16 hours before administration of the test item.
- Housing: the animals were kept individually in MAKROLON cages (type III plus) at a room tepmerature of 22 ± 3 °C and a relative humidity of 55 ± 15 %. The rooms were lit (150 lux at appoximately 1.5 m room height) and darkened for periods of 12 hours each.
- Diet: Commercial ssniff (R) R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, DE)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h of darkness / 12 h of light

IN-LIFE DATES: From: 21 March 2013 To: 25 April 2014

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 % aqueous hydroxypropylmethylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The test item was suspended in 1 % aqueous hydroxypropylmethylcellulose. The doses were 55, 175 and 550 mg silver cyanide/kg bodyweight.
- Amount of vehicle (if gavage): 20 mL/kg bodyweight
- Justification for choice of vehicle: Not reported
- Lot/batch no. (if required): Not reported.
- Purity: Not reported.

MAXIMUM DOSE VOLUME APPLIED: 20 mL/ kg bodyweight, maximum administration volume was 3.8 mL/rat

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available data indicated an LD50 of 123 mg/kg in rats.
Doses:
Dosing was initiated at 55 mg/kg bw and continued using a progrssion factor of approximately 3.2. The resulting sequence was 55, 175, 55, 175, 550, 175, 550 and 175 mg/kg bw. Each dose level was conducted with one female rat.
No. of animals per sex per dose:
2 female rats at 55 mg/kg bw
4 female rats at 175 mg.kg bw
2 female rats at 550 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Observations were performed before dosing, during dosing, at 5, 15, 30 and 60 minutes and 3, 4, 6 and 24 hours after administration. all surviving animals were observed for a period of 14 days. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death. Changes in weight were calculated if survival exceeds one day.
- 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. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on mortality were made at least once daily to minimize loss of animals during the study.
Statistics:
The LD50 was calculated using the method of maximum likelihood.

Results and discussion

Preliminary study:
Available information indicated an LD50 of 123 mg/kg in rats. Thus, the Limit Test could be omitted and the study started with the Main Test.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
175 mg/kg bw
Based on:
test mat.
95% CL:
62.5 - 487
Remarks on result:
other: by oral administration
Mortality:
A single oral administration of 55 mg/kg bw resulted in no premature deaths. Two of four animals died after dosing with 175 mg/kg bw and two of two animals died after dosing with 550 mg/kg bw.
Clinical signs:
other: At 55 mg/kg bw clinical observations included reduced motility, ataxia, tremor, reduced muscle tone, dyspnoea and pilo-erection in 2 of 2 female animals, tonic convulsions and ptosis in 1 animal. All clinical signs had resolved within 24 hours of dosing.
Gross pathology:
No signs or abnormalities observed.
Other findings:
Not reported.

Any other information on results incl. tables

Table 1. Summarised results

Symptoms/criteria

55 mg/kg (n=2) females

175 mg/kg (n=4) females

550 mg/kg bw (n=2) females

Mortality

6 h

24 h

7 d

14 d

 

0

0

0

0

 

1

2

2

2

 

2

2

2

2

Mean body weight (g)

Start

178.5

185.0

190.0

After 7 d

217.5 (+21.8)

204.5 (+10.5)

ƚ

After 14 d

230.5 (+29.1)

221.5 (+19.7)

 

Inhibition of body weight gain

none

none

ƚ

Necropsy findings

none

none

none

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethat dose (LD50) of silver cyanide in the female rat was estimated to be 175 mg/kg bodyweight.
Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of silver cyanide in rats. The study was conducted according to GLP and OECD 425 guideline.

Methods

Female rats were dosed with silver cyanide by oral gavage. Dosing was initiated at 55 mg/kg bw and continued using a progression factor of approximately 3.2 according to up-and-down procedure. The resulting sequence was 55, 175, 55, 175, 550, 175, 550 and 175 mg/kg bw. Each dose level wass conducted with one female rat. Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed before dosing, during dosing and 5, 15, 30 and 60 minutes and 3, 4, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days.

Results

Mortality

A single oral administration of 55 mg/kg bw resulted in no premature deaths. Two of four animals died after dosing with 175 mg/kg bw and two of two animals died after dosing with 550 mg/kg bw.

Clinical signs

Clinical observations at 55 mg/kg bw included reduced motility, ataxia, tremor, reduced muscle tone, dyspnoea and pilo-erection in 2 of 2 female animals, tonic convulsions and ptosis in 1 animal. All clinical signs had resolved within 24 hours of dosing. Reduced motility, ataxia, tremor, reduced muscle tone, dyspnoea and pilo-erection in 4 of 4 female animals, and tonic convulsions, STRAUB tail, ptosis and mydriasis in 2 animals were observed at 175 mg/kg bw. Abnormal abdominal position and abnormal dorsal position were noted in one animal which died prematurely. In the surviving two animals all clinical signs had resolved within 24 hours of dosing. At 550 mg/kg bw clinical observations were reduced motility, ataxia and dyspnoea in 2 of 2 female animals, tremor, reduced muscle tone, tonic convulsions, pilo-erection, ptosis and abnormal dorsal position in 1 animal.

Bodyweight

All animals gained the expected body weight.

Necropsy

No sings or abnormalities were observed at necropsy.

Conclusion

The acute lethal dose (LD50) of silver cyanide in the female rat was estimated to be 175 mg/kg bodyweight with 95 % confidence intervals of 62.5 to 487 mg/kg bw.