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EC number: 238-242-6 | CAS number: 14306-25-3
- 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:
- 11. Sep. 2017 - 15. Sep. 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, Version 439, adopted 28. July 2015,
“In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method” - Deviations:
- yes
- Remarks:
- The pre-incubation time was 1 hour, instead of 18- 24 hours. This can be seen as uncritical, because the pre-incubation time must be at least 1 hour (in consultation with the tissue supplier; MatTek In Vitro Life Science Laboratories).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EU) No. 640/2012 amending Regulation (EC) No.440/2008,
Annex III, EU method B.46 “IN VITRO SKIN IRRITATION: RECONSTRUCTED HUMAN
EPIDERMIS MODEL TEST”, adopted 06. Jul. 2012 - Deviations:
- yes
- Remarks:
- The pre-incubation time was 1 hour, instead of 18- 24 hours. This can be seen as uncritical, because the pre-incubation time must be at least 1 hour (in consultation with the tissue supplier; MatTek In Vitro Life Science Laboratories).
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt
- EC Number:
- 238-242-6
- EC Name:
- Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt
- Cas Number:
- 14306-25-3
- Molecular formula:
- C6H18O24P6.xNa
- IUPAC Name:
- Esters of sodium hydrogen phosphate with myo-Inositol, plant-derived (old name: myo-Inositol, hexakis(dihydrogen phosphate), sodium salt)
- Test material form:
- solid: bulk
- Details on test material:
- - Appearance: white solid powder
- Homogeneity: homogenous
- Density: 2.0401 ± 0.0009 g/cm3 at 20 ± 0.2 °C
- Moisture content: 0.1 - 10% (water is an inherent constituent of the UVCB substance)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
Evonik Dr. Straetmans GmbH
- Expiration date of the lot/batch:
NA2253
- Purity test date:
June 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
The test item was stored in the test facility away from light and humidity in a closed vessel at room temperature (20 ± 5°C).
- Stability under test conditions:
H2O: unknown; EtOH: 96h; acetone: 96h; CH3CN: 96h;
DMSO: 96h
- Solubility and stability of the test substance in the solvent/vehicle:
H2O: >1 g/L; EtOH: unknown; acetone: unknown; CH3CN:
unknown; DMSO: unknown
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
unknown
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
none
- Preliminary purification step (if any):
none
- Final dilution of a dissolved solid, stock liquid or gel:
none
- Final preparation of a solid:
none
FORM AS APPLIED IN THE TEST
white solid powder (not different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
not applicable
OTHER SPECIFICS:
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- other: Keratinocyte strain 00267
- Details on animal used as source of test system:
- no animals used as source of test system
- Justification for test system used:
- The test system (EpiDerm Skin Irritation Test (EPI-200-SIT) is one of the validated reference methods (VRMs) included in Annex 2 the Test Guideline OECD 439. For this VRMs, pre-validation, optimisation and validation studies have been completed and the VRMs have been used to develop the present Guideline OECD 439 and the Performance Standards.
- Vehicle:
- other: Dulbecco’s Phosphate Buffered Saline solution
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:
MatTek Corporation’s Reconstructed Human Epidermal Model EpiDermTM (EPI-200-SIT)
- Tissue batch number(s):
25841
- Production date:
not available
- Shipping date:
not available
- Delivery date:
13. Sep. 2017
- Date of initiation of testing:
13. Sep. 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during pre-treatment incubation:
37°C ± 1°C
- Temperature used during treatment / exposure:
37°C ± 1°C
- Temperature of post-treatment incubation (if applicable):
37°C ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps:
1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately with DPBS in 1-minute-intervals.
After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL).
Then, the tissues were set in the incubator for 22 hours at 37 ± 1°C and 5.0 ± 0.5% CO2. After post-incubation the tissues were removed from the incubator and shaken for
5 minutes (120 rpm). Then, the inserts were transferred into fresh assay medium (0.9 mL) and were incubated for 16 hours for post-incubation at 37 ± 1°C and 5.0 ± 0.5 % CO2.
- Observable damage in the tissue due to washing:
not reported
- Modifications to validated SOP:
No deviations from the study plan were observed.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:
1 mg/mL
- Incubation time:
3 hours at 37 ± 1°C and 5.0 ± 0.5% CO2.
- Spectrophotometer:
Microtiter plate photometer "Anthos Reader 2010 Flexi" (Anthos Microsysteme GmbH)
- Wavelength:
570 nm
- Filter:
570 nm
- Filter bandwidth:
not reported
- Linear OD range of spectrophotometer:
not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
Result: 1.27 ± 0.071 (OD 540-570 nm)
Method: MTT QC assay (4 hrs, n=3)
Acceptance criteria tissue viability: 1.0-3.0 (OD 540-570 nm) (Pass)
- Barrier function:
Result (ET-50): 6.28 hours
Method: ET-50 assay (100µl 1% Triton x-100, 4 time-points, n=3, MMT assay)
Acceptance criteria for ET-50: 4.77-8.72 hours (Pass)
- Morphology:
Tissue viability and the barrier function test are within the acceptable ranges and indicate appropriate formation of the epidermal barrier, the presence of a functional stratum corneum, a viable basal cell layer, and intermediate spinous and granular layers.
- Contamination:
No contamination (sterile) (Pass)
- Reproducibility:
Values for negative control and for positive control were within the range of historical data of the test facility:
Negative control (OD): 1.965 (historical range: 0.476 - 2.471)
Positive control (% OD compared to Negative Control): 2.5% (historical range: 1.8 - 17.1%)
NUMBER OF REPLICATE TISSUES:
Three tissue replicates were used for the test item and for the controls.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The two pre-tests (testing the ability of direct MTT reduction and the testing the ability of color formation without MTT addition) both resulted in a colourless solution. Therefore, the test item is not presumed to directly reduce the MTT and further not to develop a colour without MTT addition.
As a consequence, additional tests ("Direct Reduction of MTT with freeze killed Tissues" and "Binding capacity) had not to be performed and no data correction was necessary.
- Fresh tissues / killed tissues:
not applicable
- Procedure used to prepare the killed tissues (if applicable):
not applicable
- N. of replicates:
not applicable
- Method of calculation used:
not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
One valid experiment was performed.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive or irritant to skin if the tissue viability is less or equal 50%
- The test substance is considered to be non-irritant to skin if the viability is greater than 50%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439:
not applicable - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
26.1 mg (Tissue 1)
26.3 mg (Tissue 2)
25.3 mg (Tissue 3)
- Concentration (if solution):
The tissues were wetted with 25 μL DPBS buffer before applying the test item and spreading
it to match the tissue size (mean conc. 1.012 g/mL).
VEHICLE
- Amount(s) applied (volume or weight with unit):
The tissues were wetted with 25 μL DPBS buffer before applying the test item and spreading
it to match the tissue size
- Concentration (if solution):
not applicable
- Lot/batch no. (if required):
not applicable
- Purity:
not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
30 μL DPBS buffer
- Concentration (if solution):
not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
30 μL 5% SDS solution
- Concentration (if solution):
SDS solution (5%) - Duration of treatment / exposure:
- 1 hour (25 minutes at RT and 35 minutes at 37 ± 1°C)
- Duration of post-treatment incubation (if applicable):
- - 22 hours at 37 ± 1°C and 5.0 ± 0.5% CO2 in 0.9 mL fresh assay medium
- shaken for 5 minutes (120 rpm)
- 16 hours at 37 ± 1°C and 5.0 ± 0.5% CO2 in 0.9 mL fresh assay medium
- after post-incubation followed the MTT assay - Number of replicates:
- Three tissue replicates were used for the test item and for the controls.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 1
- Value:
- 84.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2
- Value:
- 87.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2
- Value:
- 82.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 84.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- ± standard deviation: 2.4%
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system:
not reported
- Direct-MTT reduction:
not direct-MTT reduction observed
- Colour interference with MTT:
no colour interference with MTT observed
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
Yes; The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: The mean optical density of the three tissues was 1.965. Variation
within replicates (standard deviataion) was 5.2% and therefore within the accepted range (required: ≤ 18%). Values for negative control were within the range of historical data of the test facility.
- Acceptance criteria met for positive control:
Yes; The positive control reduced absorbance to 2.5% compared to the negative control (required ≤ 20%). Variation within replicates (standard deviataion) was 0.2% and therefore within the accepted range (required: ≤ 18%). Values for positive control were within the range of historical data of the test facility.
- Acceptance criteria met for variability between replicate measurements:
Yes; Variation within replicates (standard deviataion) was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
- Range of historical values if different from the ones specified in the test guideline:
Negative control (DPBS buffer) (OD): 0.476 - 2.471
Positive control (5% SDS) (% OD compared to Negative control): 1.8 - 17.1 %
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not irritating to skin
- Conclusions:
- The results in this in-vitro skin irritation test with the EpiDerm model indicates that the test item dermofeel PA-3 (dried) is not irritant.
- Executive summary:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with the test item dermofeel PA-3 (dried) 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 control. After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.5% (required: ≤ 20%). The variation within the tissue replicates of negative, control, positive control and test item was acceptable (required: ≤ 18%). For these reasons, the experiment was considered to be valid.
After the treatment with the test item, the mean value of relative tissue viability was reduced
to 84.7 %. 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, dermofeel PA-3 (dried) is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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