Ammonium hydrogencarbonate

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium hydrogencarbonate

EC Number:

213-911-5

EC Name:

Ammonium hydrogencarbonate

Cas Number:

1066-33-7

Molecular formula:

CH2O3.H3N

IUPAC Name:

ammonium hydrogen carbonate

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 or test system 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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 576 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 470 mg/kg bw

Effect levels 3

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:

other: 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)

Gross pathology:

Animals that died (males and females): general congestion; glandular stomach; mucosa slight reddened
Sacrificed animals (males and females): no pathologic findings noted