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EC number: 206-323-5 | CAS number: 327-62-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-01-05 to 2021-04-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 26 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium propionate
- EC Number:
- 206-323-5
- EC Name:
- Potassium propionate
- Cas Number:
- 327-62-8
- Molecular formula:
- C3H6O2.K
- IUPAC Name:
- potassium propionate
- Test material form:
- solid: particulate/powder
Constituent 1
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µL
- Concentration (if solution): 20% (w/v)
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 240 ± 10 minutes for incubation with the test item and 90 ± 5 minutes for the treatment with Na-fluorescein
- Number of animals or in vitro replicates:
- three corneas per treatment
- Details on study design:
- NUMBER OF REPLICATES triplicate
NEGATIVE CONTROL USED yes physiological saline
POSITIVE CONTROL USED yes, 20% Imidazole solution
APPLICATION DOSE AND EXPOSURE TIME 750 µL of a 20% solution (either test item or Imidazole) were applied on the corneas for 240 ± 10 minutes
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least three washing steps
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance (I = luminous flux per area, unit: lux) by a light meter. The change in opacity for each individual cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final post-treatment reading. The corrected opacity for each treated cornea with the test item or positive control was calculated by subtracting the average change in opacity of the negative control corneas from the change in opacity of each test item or positive control treated cornea.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria as indicated in the TG were used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- treatment
- Value:
- 6
- Vehicle controls validity:
- valid
- Remarks:
- IVIS: 1
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks:
- IVIS: 121
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The present study conducted according to OECD TG 437 (26 June 2020) revealed that treatment of bovine corneas with a 20% (w/v) solution in physiological saline of Potassium Propionate for 4h resulted in an IVIS of 6. According to OECD TG 437 the IVIS of the substance was > 3 and < 55, thus, no prediction can be made.
- Executive summary:
This in vitro study was performed to assess them corneal irritation and damage potential of Potassium Propionate (20% in physiological saline) by means of the BCOP assay using fresh bovine corneae according to OECD guideline 437, adopted 26 June 2020.
The corneae were incubated with the test substance and controls for 240± 1 min. After rinsing with saline, the corneae were incubated for another 90 ± 5 min for treatment with Na-fluorescein. The test was performed in triplicates. Opacity and permeability were determined. The in vitro irritancy score (IVIS) were calculated as mean opacity value + (15 x mean OD490 value); a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.
A 20% dilution of the test substance in physiological saline caused an increase of the corneal opacity and permeability. The calculated mean in vitro irritation score was 6.
The positive control (20% (w/v) Imidazole) increased the opacity and permeability of the corneae in both experiments (mean in vitro irritation score 121).
With the negative control (physiological saline) neither an increase of opacity nor permeability of the corneae could be observed in both experiments (mean in vitro irritation score 1.0).
Since the mean in vitro irritancy score of the test substance was <55.1, a 20% dilution Potassium Propionate in physiological saline is considered to not be severely irritating/ corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
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