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EC number: 243-077-8 | CAS number: 19455-20-0
- 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:
- 14 Jan 2019 - 18 Jan 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 28. July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted 06. Jul. 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium isobutyrate
- EC Number:
- 243-077-8
- EC Name:
- Potassium isobutyrate
- Cas Number:
- 19455-20-0
- Molecular formula:
- C4H8O2.K
- IUPAC Name:
- potassium 2-methylpropanoate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: sponsor / 181101001
- Expiration date of the lot/batch: 31. Oct. 2020
- Purity test date: 16 Jan 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature (20 ± 5 °C); Keep away from humidity. The test item was stored in the test facility in a closed vessel at room temperature (20±5°C), protected from humidity.
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle:
Stability in solvents: H2O: 96h; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility: H2O: > 1 g/L; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- other: human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM / EPI-200-SIT
- Tissue batch number(s): 28679
- Delivery date: 15. Jan. 2018
- Date of initiation of testing: 19 Jan 2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation (if applicable): 37 ± 1°C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ml
- Incubation time: 42 hours and 25 minutes
- Spectrophotometer: plate spectrophometer
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive or irritant to the skin if the tissue viability is less than or equal to 50% of the negative control.
- The test substance is considered to be non-irritant to skin if tissue viability is greater than 50% of the negative control tissue viability - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
Tissue 1: 25.7 mg
Tissue 2: 26.4 mg
Tissue 3: 25.9 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS buffer
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% SDS-solution, a nylon mesh was added in order to ensure sufficient contact with the tissue surface. - Duration of treatment / exposure:
- Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates were transferred into the incubator for 35 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2.
- Duration of post-treatment incubation (if applicable):
- Tissues were set in the incubator for 23 hours and 30 minutes hours at 37 ± 1°C and 5.0 ± 0.5% CO2.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean (3 tissues)
- Value:
- 54.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
-
DEMONSTRATION OF TECHNICAL PROFICIENCY:
The validity of the skin irritation study at LAUS GmbH was demonstrated in a proficiency study. For this purpose, 10 proficiency chemicals (indicated by the OECD 439 guideline) were tested.
All of the 10 proficiency chemicals were correctly categorized. Therefore, the proficiency of the skin irritation study was demonstrated.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Findings and Results
Measured Values
As blank, the optical density of isopropanol was measured in 8 wells of the 96-well-plate. The measured values and their mean are given in the following table:
Table 1. Absorbance values blank isopropanol (OD 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.034 |
0.034 |
0.037 |
0.037 |
0.035 |
0.04 |
0.035 |
0.035 |
0.035 |
The absorbance values of negative control, test item and positive control are given in the following table:
Table 2. Absorbance Values negative control, test item and positive control (OD 570 nm)
Designation |
Measurement |
Negative Control |
Potassium isobutyrate |
Positive Control |
Tissue 1 |
1 |
1.727 |
0.885 |
0.080 |
2 |
1.696 |
0.874 |
0.080 |
|
Tissue 2 |
1 |
1.706 |
0.910 |
0.075 |
2 |
1.698 |
0.899 |
0.075 |
|
Tissue 3 |
1 |
1.626 |
1.012 |
0.080 |
2 |
1.617 |
1.002 |
0.079 |
From the measured absorbances, the mean of each tissue was calculated, subtracting the mean absorbance of isopropanol as given in table 9.1-a. The mean of the three tissues was also calculated.
Table 3. Mean Absorbance Values
Designation |
Negative Control |
Potassium isobutyrate |
Positive Control |
Mean – blank (tissue 1) |
1.677 |
0.845 |
0.045 |
Mean – blank (tissue 2) |
1.667 |
0.870 |
0.040 |
Mean – blank (tissue 3) |
1.587 |
0.972 |
0.045 |
Mean of the three tissues |
1.644 |
0.896 |
0.043 |
Comparison of Tissue Viability
For the test item and the positive control, the following percentage values of tissue viability were calculated in comparison to the negative control:
Table 4. % Tissue Viability
Designation |
Potassium isobutyrate |
Positive Control |
% Tissue viability (tissue 1) |
51.4% |
2.7% |
% Tissue viability (tissue 2) |
52.9% |
2.4% |
% Tissue viability (tissue 3) |
59.1% |
2.7% |
% Tissue viability (mean) |
54.5% |
2.6% |
± SD of mean tissue viability (%) |
4.1% |
0.2% |
Assessment and Validity
Skin Irritation Potential of the Test Item
The mean value of relative tissue viability of the test item was reduced to 54.5 % after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.
Validity and Acceptability
Validity criteria and results are stated in the following table:
Table 5. Validity
Criterion |
Demanded |
Found |
OD of negative control |
≥0.8 and≤ 2.8 |
1.6 |
% tissue viability |
£20% of negative control |
2.6% |
SD of mean viability of the tissue replicates (%) |
≤18% |
3.0% (negative control) |
All validity criteria were met.
Values for negative control and for positive control were within the range of historical data of the test facility.
Therefore, the experiment is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Potassium isobutyrate is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 54.5%. This value is above the threshold for skin irritation (50%). Therefore the substance is not considered to require classification for irritancy in accordance with Regulation (EC) No. 1272/2008. - Executive summary:
Findings and Results:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with the test item for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).
DPBS-buffer was used as negative control and 5% SDS solution was used as positive con-trol.
After treatment with the negative control, the mean absorbance value was within the re-quired acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.6.
The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.6% (required: less than or equal to 20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%).
After the treatment with the test item, the mean value of relative tissue viability was reduced to 54.5 %. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.
Therefore, the test item Potassium isobutyrate is considered non- irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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