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EC number: 206-059-0 | CAS number: 298-14-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- 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
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Applicant's summary and conclusion
- 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.
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