Silver

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-08-09 to 1993-09-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no information on the purity of test item is given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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

Test material information

Constituent 1

Reference substance name:

Silver

EC Number:

231-131-3

EC Name:

Silver

Cas Number:

7440-22-4

Molecular formula:

Ag

IUPAC Name:

Silver

Details on test material:

- Name of test material (as cited in study report): silver powder CAP 9
- Physical state: grey powder
- Storage condition of test material: room temperature, white plastic container
- Particle size: <40 µm

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 (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 154 - 175 g (males) and 140 - 155 g (females)
- Fasting period before study: yes, an overnight fast immediately before dosing and for approximately 2 hours after dosing
- Housing: 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 Servoces Limited)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): 48 - 57
- Air changes (per hr): 15
- Photoperiod: 12 hours dark/light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION:
- Rationale for the selection of the starting dose: a range-finding study with a fmale and a male rat receiving 2000 mg/kg of the test substance

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: for 14 days
- Frequency of observations and weighing: The animals were observed for deaths or signgs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily. Individual body weights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths observed.

Clinical signs:

other: There were no clinical signs of toxicity during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No other findings were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material, silver powder CAP 9, in the Sprangue-Dawley strain rat was found to be greater than 2000 mg/kg body weight. No symbol and risk phrase are required.