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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-01-07 to 2021-04-xx
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 20 July 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with 5 µL Milli_Q water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small Model™ EPISKIN-SM™, 0.38 cm2
- Tissue batch number(s): Batch no.: 21EKIN002
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 15±0.5 min at room temperature
- Temperature of post-treatment incubation (if applicable): 42±1 h at 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the exposure period of 15 ± 0.5 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test item. After rinsing, the cell culture inserts were each dried carefully and moved to a new well on 2 mL pre-warmed maintenance medium until all tissues were dosed and rinsed.
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3mg/mL
- Incubation time: 3h
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: SDS concentration, MTT test: 1.5 mg/mL ≤ IC50 ≥ 3.0 mg/mL; result: 1.9 mg/mL
- Barrier function:
- Morphology:HES stained paraffin section: Multi-layered differentiated epidermis consisting of organized basal, spinous and granular layers, and a multilayered stratum corneum; result: Satisfactory;
Number of cell layers ≥ 4; result: 7.5 cell layers
- Contamination: Absence of HIV1 and 2 antibodies, hepatitis C antibodies and hepatitis B antigens HBs were verfied in the donors blood.
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The test item was checked for color interference in aqueous conditions. Addition of the test item to Milli-Q and isopropanol resulted after subtraction of the blank in an OD of -0.0023 and 0.0001, respectively. Therefore it was concluded that the test item did not induce color interference. In addition, because no color change was observed in the presence of MTT it was concluded that the test item did not interact with the MTT endpoint.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: One experiment with 3 tissues per test item and controls were used.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
- The test substance is considered to be non-irritant to skin if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 21.1 to 29.1 mg moistened with 5µL Milli-Q water
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL PBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL SDS
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 15 ± 0.5 min at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h at 37°C post incubation
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- #1
- Value:
- 101
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, see any other information on results incl. tables
- Acceptance criteria met for positive control: Yes, see any other information on results incl. tables
- Acceptance criteria met for variability between replicate measurements: Yes, see any other information on results incl. tables
- Range of historical values if different from the ones specified in the test guideline:
see any other information on results incl. tables
Any other information on results incl. tables
Individual measurements of OD at 570 nm:
| A | B | C |
(OD570) | (OD570) | (OD570) | |
Negative control |
|
|
|
OD570 measurement 1 | 1.3021 | 1.1217 | 1.1602 |
OD570 measurement 2 | 1.3011 | 1.1538 | 1.2347 |
Test item |
|
|
|
OD570 measurement 1 | 1.2175 | 1.1848 | 1.2185 |
OD570 measurement 2 | 1.2863 | 1.2353 | 1.2070 |
Positive control |
|
|
|
OD570 measurement 1 | 0.0729 | 0.1694 | 0.0892 |
OD570 measurement 2 | 0.0720 | 0.1732 | 0.0927 |
OD = Optical density
Triplicate exposures are indicated by A, B and C.
Historical control data for In Vitro Skin Irritation Studies:
| Negative control (absorption; OD570) | Positive control (absorption; OD570) |
Range | 0.507 – 1.426 | 0.026 – 0.549 |
Mean | 1.020 | 0.108 |
SD | 0.155 | 0.087 |
n | 147 | 147 |
SD = Standard deviation
n = Number of observations
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Potassium Propionate (100% a.i.) was not irritating in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
In a dermal irritation study performed in accordance with OECD Guideline 439 (In Vitro Skin Irritation) (adopted June, 26, 2020), Potassium propinate (100% a.i.) was applied to the three-dimensional human epidermis model tissue for an exposure period of 15 minutes in triplicates. 5 μL of deionised water were topically applied to the epidermal surface in order to improve further contact between the solid and the epidermis. Each approximately 20 - 30 mg of the test item were applied to the wetted tissues. The test item was spread to match the surface of the tissue.
After 15 minutes exposure at room temperature, the tissues were washed with phosphate buffered saline to remove any residual test material. Subsequently the tissue constructs were incubated for 42 h at 37°C. Cytotoxicity (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
The positive (5% SDS) and negative (PBS) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after 15 minutes treatment with Potassium Propionate compared to the negative control tissues was 101%. Since the mean relative tissue viability for the test substance was above 50%, Potassium Propionate is identified to be not irritating.
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