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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national (US) standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959
- Principles of method if other than guideline:
- Test substance was applied to two sites per animal, an abraded and an intact site, and held under occlusive dressing for 24 hours
- GLP compliance:
- 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
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, 4540 Lengerich, Germany
- Age at study initiation: 11 -17 weeks, male
- Weight at study initiation: 2.39 - 2.87 kg
- Housing: individual in screen bottom cages
- Diet: ad libitum, Ssniff K, laboratory rabbit chow (Ssniff Versuchstier-Diäten GmbH, 4770 Soest/ Westfalen, Germany)
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours dark/light cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, one site abraded, one site intact
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test substance per application site (as delivered by the sponsor), moistened with physiological saline - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: trunk
- Type of wrap if used: occlusive
The dorsal area of the trunk of six rabbits was clipped one day before treatment with an electric clipper (Aesculap Favorita II).
Before start of treatment the right sites of each animal were scarified to induce a lesion of stratum corneum, without cause of bleeding or injury of the dermis.
A portion of 500 mg test substance was moistened with physiological saline and applied to each of the test sites, on abraded and one intact per animal and covered with a 2.5 x 2.5 cm gauze patch.
The gauze patch was secured with a self-adhesive, occlusive dressing. After 24 hours the coverings were removed and remaining test substance was wiped off with a disposal paper. Animals were examined for signs of erythema and edema one to two hours, and 48 hours after patch removal.
SCORING SYSTEM: as stipulated by Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no reading at 48 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no reading at 48 h
- Irritant / corrosive response data:
- Intact skin: sites were free of erythema and edema at both readings 24 and 72 hours after substance application (= 1 and 48 hour(s) after patch removal).
Abraded skin: very slight erythema (score 1), with partly slight, white discolorations was observed in all animals at both readings 24 and 72 hours after substance application (= 1 and 48 hour(s) after patch removal). At both readings abraded skin sites were free of edema.
Any other information on results incl. tables
Intact skin: all readings were 0.
Abreaded skin: 24 and 72 hours after test substance application (= 1 and 48 hour(s) after patch removal): erythema score 1, with partly slight, white discolorations in 6/6 animals; edema score 0 in 6/6 animals
Average skin irritation index (Primary Dermal Irritation Index (PDII), maximal possible index of 8) calculated by the study authors: 0.5. Effects on intact and abraded skin were included in the index calculation.
Based on this Index the test item was considered to be a mild skin irritant by the study authors.
Scheme for interpretation of results used by the study authors:
Primary Skin Irritation Score (PDII)
0 : non irritant
> 0 - 2: mild irritant
> 2 - 5: moderate irritant
> 5: severe irritant
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification is based on erythema/eschar and oedema of intact skin calculated as mean scores following grading at 24 and 72 hours after substance application, in consideration of reversibility.
According to CLP, EU GHS (Regulation (EC) No 1272/2008) "Kaliumbikarbonat" (potassium hydrogencarbonate) is classified as non skin irritant. - Executive summary:
In a primary dermal irritation study according to FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959, six New Zealand White rabbits were dermally exposed to 500 mg of test substance “Kaliumbikarbonat” (potassium hydrogencarbonate) per test site. The substance was administered for 24 hours to abraded and intact shaved body surface areas of 2.5 cm² each under occlusive conditions. Animals then were observed for further 48 hours. Irritation was scored by the method stipulated by Draize 1959 one to two hours, and 48 hours after patch removal (= 24 and 72 hours readings).
The intact skin sites were free of erythema and edema at both readings 24 and 72 hours after substance application.
The abraded skin sites of all animals showed a very slight erythema (score 1), with partly slight, white discolorations at both readings 24 and 72 hours after substance application. At both readings abraded skin sites were free of edema.
In this study, test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) is not a dermal irritant.
No classification for skin irritation/corrosion is justified for "Kaliumbikarbonat" (potassium hydrogencarbonate) according to the following regulations:
- CLP - (EU-GHS), Regulation (EC) No 1272/2008
- OECD GHS (2nd rev. edition, UN, 2007)
According to the skin irritation/corrosion test guidelines EU Method B.4 and OECD TG 404 stipulated in COUNCIL REGULATION (EC) No 440/2008, only intact skin should be treated. Therefore, reactions of abraded skin are not included in the classification given above.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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