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Administrative data

Description of key information

There is no evidence on an intrinsic acute toxic activity of potassium hydrogencarbonate after oral, dermal or inhalation exposure. In rats, the oral and dermal LD50 is > 2000 mg/kg bw  and the LC50 is > 4.88 +/- 0.60 mg/L. In addition, absence of intrinsic toxic properties of potassium hydrogencarbonate by oral exposure of humans is generally taken for granted, which is proved by its long-standing safe use in food and pharmaceuticals and its GRAS (generally recognized as safe) status in the USA.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
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
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-10-14 to 1993-10-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Inhalation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA, USA
- Age at study initiation: no data in study summary
- Weight at study initiation: 219 - 256 g
- Fasting period before no data in study summary
- Housing: no data in study summary
- Diet (e.g. ad libitum): no data in study summary
- Water (e.g. ad libitum): no data in study summary
- Acclimation period: no data in study summary


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data in study summary
- Humidity (%): no data in study summary
- Air changes (per hr): no data in study summary
- Photoperiod (hrs dark / hrs light): no data in study summary


Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Details on inhalation exposure:
Prior to aerosolization, the test substance was ground for 24 hours in a ball mill.
Chamber concentration and the particle size distribution of the aerosolized test substance were determined periodically during the exposure period.

The gravimetric chamber concentration was 4 .88 ± 0.60 mg/L with approximately 1 % of the particles below 1 µm and 25 % below 3 µm. The mass median aerodynamic diameter was approximately 4.7 µm.

Particle size distribution was measured by the Andersen Cascade Impactor.

Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric
Duration of exposure:
4.5 h
Concentrations:
4 .88 ± 0.60 mg/L gravimetric chamber concentration
No. of animals per sex per dose:
5 animals per sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data in study summary
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.88 mg/L air (analytical)
Exp. duration:
4.5 h
Remarks on result:
other: no animal died; 4 .88 ± 0.60 mg/L
Mortality:
No mortalities occurred as a result of exposure.
Clinical signs:
other: In-chamber animal observations were limited due to the accumulation of test substance on the walls of the exposure chamber. During the first hour of exposure, decreased activity, ocular discharge and hunched posture were noted. Upon chamber removal, simil
Body weight:
All rats gained weight over the 14-day observation period.
Gross pathology:
Gross necropsy findings at terminal sacrifice were generally unremarkable. Apart from red lung discoloration consistent with euthanasia by CO2 inhalation, all tissues and organs appeared normal.
Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results obtained after an inhalation exposure of 4.5 h, the LC50 of the test article "Potassium Bicarbonate" was determined to be > 4.88 ± 0.60 mg/L.
Executive summary:

In an acute inhalation toxicity study performed according to the US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Inhalation, which is similar to OECD Guideline 403 (Acute Inhalation Toxicity), 5 male and 5 female Sprague-Dawley rats were exposed by inhalation route to aerosolized test article “Potassium Bicarbonate” for 4.5 hours. Test substance was aerosolized after being ground in a ball mill for 24 hours. The gravimetric chamber concentration was 4.88 ± 0.60 mg/L with approximately 1 % of the particles below 1 µm and 25 % below 3 µm. The mass median aerodynamic diameter (MMAD) was approximately 4.7 µm. Animals were observed for 14 days.

LC50 Combined:  > 4.88 ± 0.60 mg/L air (analytical)

 

No animal died in this study. During the first hour of exposure, decreased activity, ocular discharge and hunched posture were noted. Upon chamber removal, similar conditions as well as facial staining and/or nasal discharge were evident. All animals recovered from these clinical signs within 24 hours. All rats gained weight over the 14-day observation period. There were no substance related gross necropsy findings at terminal sacrifice.

In this limit test the determined LC50 is > 4.88 ± 0.60 mg/L air (analytical). As no animal died, it is considered to be appropriate not to classify the substance for acute inhalation toxicity according to CLP, EU GHS (Regulation (EC) No 1272/2008).

EU GHS limit values for acute inhalation toxicity are 1.0 < category 4 ≥ 5.0 mg/L for dust/mist. Furthermore the exposure time was slight increased (4.5 h) when compared with the EU GHS requirement of 4 hours inhalation exposure.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
4 880 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-01-21 to 1993-06-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Albino rabbits strain Hra:(NZW)SPF
- Source: Hazleton Research Products, Inc., Hazleton Wisconsin facility at 3802 Packers Avenue, Madison, Wisconsin, USA
- Age at study initiation: young adults
- Weight at study initiation: males 2431 to 2829 g (mean 2602 g), females 2432 to 2699 g (mean 2596 g)
- Fasting period before study: no data in study summary
- Housing: individually housed in screenbottom cages in temperature- and humidity-controlled quarters
- Diet: ad libitum, High Fiber Rabbit ChoW® #5326, Purina Mills, Inc., USA
- Water: ad libitum
- Acclimation period: 21 days


ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidit:y: 54 to 67% relative humidity
- Air changes (per hr): no data in study summary
- Photoperiod (hrs dark / hrs light): no data in study summary
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back, clipped free of hair with an electric clipper. The clipped area made up not less than10% of the total body surface.
- % coverage: 10 x 10 cm patch
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test sites were washed using tap water and disposable paper towels
- Time after start of exposure: 24 hours

Preparation of Test Material
An individual dose of test material was calculated and weighed out based on each animal's body weight on the day of test material administration. Each dose was thoroughly moistened with 0.9% saline before application.

Treatment
The test material was applied to the intact skin on each animal's back at a dose level of 2000 mg/kg of body weight. The area of application was covered with a 10-cm x 10-cm gauze patch secured with paper tape and overwrapped with Saran Wrap® and Elastoplast® tape. The test material was applied to the test site at a rate of approximately 0.05 g/cm2 in a thin and uniform layer. Collars were used to restrain the test animals during the 24-hour exposure period. At the end of the 24-hour exposure period, the restraining collars and bandages were removed and the test sites were washed using tap water and disposable paper towels.




Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- Clinical observations and mortality checks were conducted at approximately 1, 2.5, and 4 hours after test material administration. Additional clinical observations and twice a day mortality checks (morning and afternoon) were conducted daily thereafter for 14 days.
--Body weights were determined before test material application (Day 0), at Day 7, and at termination of the experimental phase (Day 14).
-- The initial dermal irritation reading was made approximately 30 minutes after removal of the test material according to the Draize technique (recorded as the Day 1 score). Subsequent readings of dermal irritation were made on Days 3, 7, 10, and 14.
- Necropsy of survivors performed: yes, At termination of the experimental phase, all animals were euthanized, subjected to an abbreviated gross necropsy examination, and any abnormalities were recorded.
- Other examinations performed: no
Statistics:
No
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died
Mortality:
All animals survived.
Clinical signs:
All animals appeared clinically normal throughout the study.
Body weight:
All animals gained weight.
Gross pathology:
The gross necropsy at termination revealed no visible lesions with the exception of an incidental dermal finding in one animal.
Other findings:
Dermal reactions:
Dermal irritation (based on the most severe score for each animal at any time point) consisted of slight to moderate erythema and slight edema, atonia, and desquamation (no individual scores reported in available study summary). No other dermal irritation was observed. The slight to moderate dermal irritation cleared in all animals by Day 10.

At necropsy, the skin of the mid-dorsal region of one male had multiple red, dry crusted areas of variable size. Although possibly caused by the test material, in the absence of similar changes in the skin of all other animals, these changes were probably incidental. There were no visible lesions in the remaining animals.
Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results obtained after a single dermal administration, the oral LD50 of the test article "Potassium Biarbonate"
was determined to be > 2000 mg/kg bw. All animals survived. No significant clinical signs, effects on body weight or gross pathological findings were observed apart from slight to moderate dermal irritation at the dose site of all animals.
Executive summary:

In an acute dermal toxicity study performed according to the guideline US EPA OPP 81-2 (Acute Dermal Toxicity) which is similar to OECD Guideline 402 (Acute Dermal Toxicity), 5 male and 5 female young adult albino rabbits strain Hra:(NZW)SPF were dermally exposed to the test article "Potassium Bicarbonate" moistened with 0.9% saline for 24 hours at a dose of  2000 mg/kg bw (limit test). Animals then were observed for 14 days.

 

Dermal LD50 Combined:  > 2000 mg/kg bw

 

No animal died in this limit test.       

 

No significant clinical signs or effects on body weight were observed, apart from dermal irritation at the dose site of all animals. There were no treatment related gross necropsy findings at terminal sacrifice.

 

Dermal irritation (based on the most severe score for each animal at any time point) consisted of slight to moderate erythema and slight edema, atonia, and desquamation (no individual scores reported in available study summary). No other dermal irritation was observed. The slight to moderate dermal irritation cleared in all animals by Day 10. At necropsy, the skin of the mid-dorsal region of one male had multiple red, dry crusted areas of variable size. Although possibly caused by the test material, in the absence of similar changes in the skin of all other animals, these changes were probably incidental. There were no visible lesions in the remaining animals.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Reliable, adequate and relevant acute toxicity data are available for the oral, inhalation, and dermal route.

All studies have been performed in rats as limit tests according or similar to the relevant OECD Guidelines (No. 401, 402 or 403, respectively). In none of the studies a animal died, body weight gain was affected or pathological findings were seen at necropsy. In the oral study, clinical signs were limited to piloerection during the first 30 minutes after application in all animals. The dermally treated animals appeared clinically normal throughout the study. In the inhalative study, decreased activity, ocular discharge and hunched posture during the first hour of exposure, were noted. Upon chamber removal, similar conditions as well as facial staining and/or nasal discharge were evident. All animals recovered from these clinical signs within 24 hours. The noted transient clinical signs after oral or inhalative treatment are rather signs of discomfort to dosing procedure than signs of a intoxication. Thus, there was no evidence of an intrinsic toxicity of potassium hydrogencarbonate in the acute toxicity tests. The oral and dermal LD50 is > 2000 mg/kg bw, the LC50 > 4.88 +/- 0.60 mg/L.

Justification for classification or non-classification

There is no evidence on an intrinsic acute toxic activity of potassium hydrogencarbonate after oral, dermal or inhalation exposure.

The LD50 value for the oral and dermal route was determined to be > 2000 mg/kg bw.

In a limit test via inhalation route, the determined LC50 was > 4.88 ± 0.60 mg/L air (analytical). CLP Regulation (EC) No 1272/2008 limit values for acute inhalation toxicity are 1.0 < category 4 ≥ 5.0 mg/L for dust/mist. However, as no animal died and furthermore the exposure time was slightly increased (4.5 h) when compared with the CLP Regulation (EC) No 1272/2008 requirement of 4 hours inhalation exposure, the test result is considered to be adequate not to classify the substance for acute inhalation toxicity according to CLP Regulation (EC) No 1272/2008.

According to CLP Regulation (EC) No 1272/2008, a classification for acute toxicity of potassium hydrogencarbonate is not required and labelling is not necessary.