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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-10-5 to 1992-10-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Guideline study, however no information on the purity stated.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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 carbonate
EC Number:
208-590-3
EC Name:
Silver carbonate
Cas Number:
534-16-7
Molecular formula:
CH2O3.2Ag
IUPAC Name:
disilver(1+) carbonate
Details on test material:
- Name of test material (as cited in study report): silver carbonate
- Physical state: 1ight green powder
- Storage condition of test material: in grey plastic tub, room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River ltd,. Manston, Kent, U.K.
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 121 - 136 g (males) and 124 - 145 g (females)
- Fasting period before study: an overnight fast immediately before dosing and for approximately two hours after dosing
- Housing: animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 50 - 67
- Air changes (per hr): 15
- Photoperiod: 12 hours dark/light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

METHOD
- Rationale for the selection of the starting dose: A range-finding study was performed to establish a dosing regime.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 male rats and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes; at the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
other: Common signs of systemic toxicity noted were hunched posture, lethargy and pilo-erection with additional signs of emaciation. Animals recovered two to eight days after dosing.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
no other findings were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material, silver carbonate, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg body weight.