Potassium hydrogencarbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hydrogencarbonate

EC Number:

206-059-0

EC Name:

Potassium hydrogencarbonate

Cas Number:

298-14-6

Molecular formula:

CH2O3.K

IUPAC Name:

potassium hydrogen carbonate

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 Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: male 95 - 105 g; female 100 g
- Fasting period before study: over night fasted
- Housing: individual in makrolon cages on bedding
- Diet: ad libitum, R 4 rat laboratory chow, Ssniff Versuchtier-Diäten GmbH, 4770 Soest/ Westfalen
- Water: ad libitum, tap water
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 40 - 70 %
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hour dark/light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Concentration in vehicle: 100.0 mg/ml in aqua destillata

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

- Clinical examination was performed 15 and 30 minutes, 1, 2, and 4 hours following dosing and once daily thereafter.

- Body weight measurements: on the day prior to application (study day -1), at the day of application (study day 0) and on day 7 and 14 after application.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animal died

Mortality:

0/ 10 animals died

Clinical signs:

piloerection during the first 30 minutes after application in all animals

Body weight:

normal weight gains

Gross pathology:

no macroscopic findings at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

On the basis of the results obtained after a single oral administration, the oral LD50 of the test article "Kaliumbikarbonat" (potassium hydrogencarbonate) was determined to be > 2000 mg/kg bw. No significant clinical signs, effects on body weight or gross pathological findings were observed.
No classification for acute oral toxicity is justified for test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) according to Regulation (EC) No 1272/2008.

Executive summary:

In an acute oral toxicity study (limit test, equivalent to now deleted OECD guideline 401), 5 male and 5 female, fasted Sprague-Dawley rats were given a single oral dose of 2000 mg/kg bw of test substance “Kaliumbikarbonat” (potassium hydrogencarbonate) and observed for 14 days.

Oral LD₅₀ Males and Females > 2000  mg/kg bw

No mortality occurred in this limit test. Except of piloerection during the first 30 minutes after application in all animals, there were no treatment related clinical signs, necropsy findings or changes in body weight. 

In this study, test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) is not an acute oral toxicant.