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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:
1988-09-27 to 1988-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Silver chloride
EC Number:
232-033-3
EC Name:
Silver chloride
Cas Number:
7783-90-6
IUPAC Name:
silver(1+) chloride
Details on test material:
- Name of test material (as cited in study report): silver chloride
- Physical state: white 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: The test substance was kept in a closed container at room temperature and was 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: Uinkelmann Versuchstierzucht GmbH & Co. KG., Borchen
- Age at study initiation: 8 weeks (males) and 9 weeks (females)
- Weight at study initiation: 151 - 161 g (males) and 135 - 155 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): 21 - 22.5
- Humidity (%): 45 - 65
- Photoperiod: 12 hours dark/light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Mixture of Witepsol H 15 and Miglyol 812 1 : 1.2 w/w; Miglyol 812 (Mittelkettige Triglyceride DAB 9) and Vitepsol H 15 (Hartfett DAB 9), both supplied by ASTA-Pharma AG, Frankfurt/M. 1
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 237 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg
Doses:
5110 mg/kg body weight
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 or 21 days after administration
- 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.
The body weights were recorded at the beginning and also 7 and 14 days after administration. In one male and one female rat the body weights were also determined on day 21.
- Necropsy of survivors performed: yes; at the end of the observation period the animals were sacrificed with C02. A gross necropsy was performed on all animals deceased intercurrently or sacrificed at the end of the observation period. Macroscopic examination included external appearance, body orifices, body cavities (thoracic and abdominal) and their contents.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Mortality:
Deaths did not occur.
Clinical signs:
other: The signs of toxicity were slight to moderate hypokinesia, stilted gait, piloerection, sunken sides, vocalization on handling, red crusted noses, and diarrhea with black discoloured feces. Individual rats additionally showed chromodacryorrhea and strenuou
Gross pathology:
At necropsy no changes were recorded.
Brain and spinal cord of the female rat that did not recover completely were examined microscopically, but changes could not be detected.
Other findings:
Diarrhea was caused by the vehicle alone, too.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD 50 values for silver chloride tested in a single dosewere above 5110 mg/kg for male and female rats (limit test).