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EC number: 942-582-7 | CAS number: -
- 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:
- From 12 April 2017 to 12 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- calcium dipotassium disodium trisulfate
- Molecular formula:
- SO42-, K+, Na+, Ca2+
- IUPAC Name:
- calcium dipotassium disodium trisulfate
- Test material form:
- solid
- Remarks:
- light to beige solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the Sponsor, EXP LIberica Lote: AI16503047
- Expiration date of the lot/batch: 30 November 2019
- Purity test date: 1 February 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 ºC, below 70 RH%), protected from light and humidity
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: no vehicle was used
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: the test item did not react with MTT or Medium Assay
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was used as supplied
In vitro test system
- Test system:
- artificial membrane barrier model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: reconstructed epiderdermis
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin
- Tissue batch number(s): 17-EKIN-017
- Production date: 25 April 2017
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 26 April 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1
- Observable damage in the tissue due to washing: Not specified
- Modifications to validated SOP: It was rinsed thoroughly with PBS to remove any remaining material from the epidermal surface as much as possible. The rest of the PBS was removed from the epidermal surface with a pipette (without touching the epidermis)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 3 mg/mL(stock solution) ; 0.3 mg/mL per well
- Incubation time: 3 hours (± 5 min)
- Spectrophotometer: Plate reader Thermo Fisher Scientific, Catalogue Number: 240 72800
- Wavelength: 570 nm
- Filter: not specified
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 0.805
- Barrier function: Yes
- Morphology: Well-differentiated epidermis consisting of a basal monolayer, several spinous and granular layers and thick stratum corneum
- Contamination: Absence of HIV1 and 2, Hepatitic C, Hepatitis B and absence of bacteria, fungus and mycoplasma
- Reproducibility: yes
NUMBER OF REPLICATE TISSUES: triplicates were used
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
killed tissues
- Procedure used to prepare the killed tissues (if applicable): not specified
- N. of replicates : triplicates
- Method of calculation used:
Non Specific Colour % with killed tissues (NSCkilled%):
NSCkilled % = (mean ODCTK / mean ODNC)×100
ODCTK: test substance treated killed tissues (not incubated with MTT)
ODNC: negative control OD (incubated with MTT)
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3 test sequences : Pre incubation / Application and Rinsing / MTT Test
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after after 15 minutes exposure to the test item and 42 hours post incubation is less than 50%
- The test substance is considered to be non-irritant to skin if the viability after 15 minutes exposure to the test item and 42 hours post incubation is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 439: not specified - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
As the test item was solid, first an appropriate amount (10 µL) distilled water was applied to the epidermal surface in order to improve further contact between test item and epidermis and then 20 mg of powdered the test item was applied evenly to the epidermal surface. If necessary, the test item was spread gently on the skin surface with a pipette tip (or other appropriate tool) without damaging the epidermis. The amount was sufficient to cover the epidermal surface.
CONTROLS
50 µL of negative control (PBS) or positive control (5% (w/v) SDS solution) were added to each skin unit by using a suitable pipette. Chemicals were spread gently with the pipette tip in order to cover evenly all the epidermal surface if necessary (without damaging the epidermis). - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test Item
- Value:
- 103
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Negative Control
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Positive Control
- Value:
- 3.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No effect
- Direct-MTT reduction: No effect
- Colour interference with MTT: No effect
DEMONSTRATION OF TECHNICAL PROFICIENCY: The positive control treated tissues showed 3.4% viability demonstrating the proper performance of the assay. The standard deviation of the viability results for positive control samples was 1.5.
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: The standard deviation of viability values of the three test item-treated tissue samples in the MTT assay was 4.7.
Any other information on results incl. tables
Table 1: Optical Density (OD) and the calculated relative viability % of the samples
Substance |
Optical Density (OD) |
Viability |
SD |
|||
|
Measured |
Blank corrected |
(% RV) |
|||
Negative Control: |
1 |
0.780 |
0.734 |
94.5 |
- |
|
Phosphate buffered saline |
2 |
0.846 |
0.799 |
103.0 |
||
|
3 |
0.842 |
0.796 |
102.5 |
||
|
mean |
-- |
0.776 |
100.0 |
4.7 |
|
Positive Control: |
1 |
0.067 |
0.021 |
2.6 |
- |
|
5%(w/v)SDSsolution |
|
2 |
0.065 |
0.019 |
2.4 |
|
|
3 |
0.086 |
0.040 |
5.1 |
||
|
mean |
-- |
0.026 |
3.4 |
1.5 |
|
Test Item: |
1 |
0.804 |
0.758 |
97.6 |
- |
|
Sulfates of potassium, sodium and calcium, |
2 |
0.859 |
0.813 |
104.7 |
||
by-product from fermentation |
3 |
0.874 |
0.828 |
106.6 |
||
|
mean |
-- |
0.799 |
103.0 |
4.7 |
|
Notes:
1. Mean blank value was0.047.
2. Optical density means the mean value of the duplicate wells for each sample (rounded to three decimal places).
3. SD: Standard deviation
Table 2 : HISTORICAL CONTROL DATA
(updated11 August 2016)
|
Negative control (PBS) |
Positive control (5% (w/v) SDS solution) |
Mean optical density (OD) |
0.802 |
0.094 |
Standard deviation |
0.157 |
0.048 |
Minimum optical density (OD) |
0.573 |
0.032 |
Maximum optical density (OD) |
1.362 |
0.354 |
Number of cases |
111 |
102 |
PBS: Phosphate buffered saline SDS: Sodium dodecyl sulphate OD: Optical density (absorbance)
Note: All OD values (measured at 570 ±30 nm) are background corrected values.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this in vitro EPISKINTM (SM) model test with Sulfates of potassium, sodium and calcium, by-product from fermentation (Batch number: EXP LIberica Lote: AI16503047), the results indicated that the test item was non-irritant to skin. Hence, the test item was not classified for Skin Irritation according to CLP regulation.
- Executive summary:
A GLP compliant in vitro skin irritation test of Sulfates of potassium, sodium and calcium, by-product from fermentation test item was performed in a reconstructed human epidermis model. EPISKINTM (SM) is designed to predict and classify the irritation potential of chemicals by measuring its cytotoxic effect as reflected in the MTT (3-(4,5-Dimethylthiazol-2-yl)- 2,5-diphenyltetrazolium bromide) assay (detailed in 3.6. section). The irritation potential of the test item was evaluated according to the OECD No. 439 guideline.
Disks of EPISKINTM (SM) (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in an incubator with 5% CO2 protected from light. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.
Following exposure with Sulfates of potassium, sodium and calcium, by-product from fermentation, the mean cell viability was 103.0% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid.
In conclusion, in this in vitro EPISKINTM (SM) model test with Sulfates of potassium, sodium and calcium, by-product from fermentation (Batch number: EXP LIberica Lote: AI16503047), the results indicated that the test item was non-irritant to skin. Hence, the test item was not classified for Skin Irritation according to CLP regulation.
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