Disilver(1+) sulphate

Endpoint summary

Description of key information

A reliable study available for acute oral toxicity of silver(I)sulfate is available (rat, LD50 > 5000 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.

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:

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

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 5 000 mg/kg bw

Quality of whole database:

reliable and robust database

Justification for classification or non-classification

A reliable study available for acute oral toxicity of silver(I)sulfate is available (rat, LD50 > 5000 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 reason.