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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:
1993-08-09 to 1993-09-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, however 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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
There were no clinical signs of toxicity during the study.
Body weight:
All animals showed expected gain in body weight 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.