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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ammoniumcarbonat
- Physical state: white, powder, crystalline
- Analytical purity: 99.9%
- Lot/batch No.: continuous production
- Expiration date of the lot/batch: march 1989
- Stability under test conditions: given
- Storage condition of test material: not above 40°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DR. K . Thomae, Biberach, D
- Mean weight at study initiation: males: 183 g; females 185 g
- Housing: 5 per cage
- Diet: Kliba-Labordiaet 343, Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% aqueous CMC (carboxymethyl cellulose)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml (all animals)
Doses:
215, 681, 1470, 2150 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays. Weighing was done on d0, d7 and d13.
- Necropsy of survivors performed: yes. Withdrawal of food about 16 h before sacrifice with CO2; necropsy of all animals that die as early as possible

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 576 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 470 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 470 - < 2 150 mg/kg bw
Mortality:
215 mg/kg bw: 0/5 males; 0/5 females
681 mg/kg bw: 0/5 males; 0/5 females
1470 mg/kg bw: 0/5 males; 3/5 females (within 1 h)
2150 mg/kg bw: 5/5 males; 5/5 females (all within 1 h)
Clinical signs:
Male animals (1470 mg/kg: 15 min-3 h; 2150 mg/kg: before death): Dyspnea, apathy, abnormal position, staggering, paresis, tonic convulsions, exophthalmos, salivation, poor general state.
Female animals (1470 mg/kg: 15 min-4 h; 2150 mg/kg: before death): Dyspnea, apathy, abnormal position, staggering, tonic convulsions, exophthalmos, salivation, poor general state
Body weight:
Males (mean body weight: d0/d7/d13)
215 mg/kg bw: 190 g/ 260 g/ 296 g
681 mg/kg bw: 182 g/ 251 g/ 284 g
1470 mg/kg bw: 190 g/ 247g/ 277 g

Females (mean body weight: d0/d7/d13)
215 mg/kg bw: 190 g/ 228 g/ 238 g
681 mg/kg bw: 181 g/ 207 g/ 219 g
1470 mg/kg bw: 187 g/ 217g/ 229 g
Gross pathology:
Animals that died (males and females): general congestion; glandular stomach; mucosa slight reddened
Sacrificed animals (males and females): no pathologic findings noted

Applicant's summary and conclusion