Disilver(1+) sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-11-06 to 1990-11-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline study. At the time of the study conduct, GLP was not compulsory. However, the study was conducted in accordance with the principles of GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

, only two dose groups were used instead of three for reasons of animal welfare.

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Disilver(1+) sulphate

EC Number:

233-653-7

EC Name:

Disilver(1+) sulphate

Cas Number:

10294-26-5

Molecular formula:

Ag.1/2H2O4S

IUPAC Name:

disilver(1+) sulfate

Details on test material:

- Name of test material (as cited in study report): silver(I) sulfate
- Physical state: white, crystalline powder
- Stability under test conditions: According to information from the sponsor the test substance was stable throughout the experimental period.
- Storage condition of test material: in a closed container at room temperature, protected against light

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., Borchen
- Age at study initiation: 8 - 9 weeks (males) and 9 - 10 weeks (females)
- Weight at study initiation: 147 - 209 g (males) and 135 - 159 g (females)
- Fasting period before study: 16 hours before treatment
- Housing: in Macrolon cages, type II, individually housing
- Diet: ad libitum (standard diet, ssniff R, special diet for rats)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22.5
- Humidity (%): 40 - 70
- Photoperiod: 12 hours dark/light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 110 and 237 mg/mL
- Lot/batch no. (if required): 8249, supplied by H. Lamotte, Bremen

MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg

Doses:

2370 mg/kg body weight
5110 mg/kg body weight

No. of animals per sex per dose:

5 maels and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were continuously observed for the first 4 to 6 hours after administration and then once daily. The nature of the toxicity as well as the onset, the intensity and the duration of the signs were recorded.
Mortality was checked twice daily. Time of death and number of dead animals per dose were documented.
Body weights were recorded at the beginning and also 7 and 14 days after administration or after death of the animals on days 2 to 14.
- Necropsy of survivors performed: yes; at the end of the observation period the animals were sacrificed with C02
Gross necropsy: was performed on all animals. Macroscopical examination included external appearance, body orifices, body cavities (thoracic and abdominal), and their contents.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Deaths occurred on days 5 to 7 after administration.
Mortality rates, males:
2370 mg/kg body weight = 0%
5110 mg/kg body weight = 40% (2 animals died 5 and 7 days after exposure, respectively)

Mortality rates, females:
2370 mg/kg body weight = 0%
5110 mg/kg body weight = 40% (2 animals died 6 and 7 days after exposure, respectively)

Clinical signs:

other: At a dose of 2370 mg/kg male and female animals performed diarrhea, black discoloured feces, and red nasal discharge. In male animals additionally chromodacryorrhea occurred. In one male and in one female animal each restrained gait or stilted gait, respe

Gross pathology:

At necropsy of deceased animals the stomach was tightly filled with food and the mucous membranes of glandular stomach, small and large intestine, or duodenum only were reddened. The whole intestine, cecum, or colon were filled with a discoloured fluid material. In one animal the stomach was tightly filled with white compacted material.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD 50 values were greater than 5000 mg/kg body weight (estimation) for male and female rats.