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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: dermal
Administrative data
- 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
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:
- 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
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:
- 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
Administration / exposure
- 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
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:
- 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.
Applicant's summary and conclusion
- 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.
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