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Diss Factsheets

Administrative data

Description of key information

A reliable study available for acute oral toxicity of silver(I)carbonate is available (rat, LD50 > 2000 mg/kg bw). Similar acute oral toxicity studies with other silver substances, which all indicate low acute oral toxicity, are included in this dossier for comparative reasons. Silver carbonate is not classified as acutely toxic, according to Regulation (EC) 1272/2008.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw

Additional information

Justification for classification or non-classification

A reliable study available for acute oral toxicity of silver(I)carbonate is available (rat, LD50 > 2000 mg/kg bw). Similar acute oral toxicity studies with other silver substances, which all indicate low acute oral toxicity, are included in this dossier for comparative reasons. Silver carbonate is not classified as acutely toxic, according to Regulation (EC) 1272/2008.