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EC number: 213-924-6 | CAS number: 1067-12-5
- 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:
- Experimental phase: 2018-03-13 - 2018-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phosphinylidynetrimethanol
- EC Number:
- 213-924-6
- EC Name:
- Phosphinylidynetrimethanol
- Cas Number:
- 1067-12-5
- Molecular formula:
- C3H9O4P
- IUPAC Name:
- [bis(hydroxymethyl)phosphoryl]methanol
- Test material form:
- liquid: viscous
- Details on test material:
- yellowish liquid, viscous, turbid
CAS no.: 1067-12-5
Storage conditions: at +10 to +25°C, in the tightly closed original container and stored in a cool, dry and well-ventilated place, protected from heat and sunlight
Constituent 1
- Specific details on test material used for the study:
- Tris(hydroxymethyl)phosphine oxide (THPO) was applied as liquid test item topically undiluted to the model skin surface.
In vitro test system
- Test system:
- human skin model
- Remarks:
- The EpiDermTM model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- The principle of the reconstructed human epidermis model test is based on the premise that irritant substances are able to penetrate the stratum corneum by
diffusion and are cytotoxic to the cells in the underlying layers. Cell viability was measured by dehydrogenase conversion of the vital dye MTT (3-[4,5-
Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue), into a blue formazan salt that was quantitatively measured after extraction from tissues.
Irritant substances were identified by their ability to decrease cell viability below defined threshold levels (i.e.≤ 50% for UN GHS Category 1 or Category 2).
The reconstructed human epidermis model system is suitable to test solids, liquids, semi-solids and waxes. The liquids may be aqueous or non-aqueous; solids may be soluble or insoluble in water. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM (EPI-200, Lot no. 25899) MatTek
- Tissue batch number(s): 00267
- Quality analysis date: 2018-04-25
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C for 35 min., follwed by room temperture for 25 min.
- Temperature of post-treatment incubation (if applicable): 42 hour, temperature not specified
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline (D-PBS)
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Tecan Sunrise Magellan Version 7.2
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 experiment with 2 measurements
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant or corrosive to skin if the viability is less or equal than 50%
- The test substance is considered to be non-corrosive to skin if the viability is greater than 50% - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL of test item
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): D-PBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% aqueous sodium dodecyl sulphate (SDS) - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 , Mean viability (n=3), THPO
- Value:
- >= 54.7 - <= 61.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- mean viability: 57.8 %
- 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 (vehicle): yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: see table 'any other information on materials and methods incl. tables'
Any other information on results incl. tables
Table 1 Summarized Results of in vitro Skin Irritation
Optical density [OD540] (n = 3) |
Mean Viability (n=3) [%] |
CV [%] |
|
D-PBS (negative control) |
1.320 | 100.0 | 5.2 |
DL-alpha-alanine | 1.217 | 92.2 | 5.6 |
5 % SDS (positive control) |
0.099 | 7.5 | 9.3 |
CV : coefficient of variation
SDS : sodium dodecyl sulphate
D-PBS : Dulbecco's phosphate buffered saline
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Remarks:
- not irritant to skin
- Conclusions:
- - mean value of relative tissue viability was reduced to 57.8%
- test item is considered non-irritant to skin under the conditions of the test [since obtained value is above the threshold for skin irritation potential (50%)] - Executive summary:
The purpose of this study was to determine cytotoxic properties of Tris(hydroxymethyl)phosphine oxide (THPO) to skin cells, which might lead to irritation of human skin, by using an artificial three-dimensional model of human skin according to OECD Guideline 439 and in compliance with GLP criteria.The EpiDermTM model was employed.
Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. THPO was applied to the model skin surface; D-PBS was used as the negative control and 5% aqueous sodium dodecyl sulphate (SDS) was used as the positive reference item. An exposure time of 60 minutes was employed followed by a 42-hour post-treatment incubation period in fresh medium.
The mean viability of cells exposed to THPO was 57.8 % of the negative controls and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of > 50%. THPO was considered to be non-cytotoxic and predicted to be non-irritant to skin.
All acceptance criteria required were fulfilled.
Under the present test conditions, THPO was non-cytotoxic and predicted to be non-irritant to skin in an experiment employing an artificial three-dimensional model of human skin. Hence, the test item did not show irritant properties and is therefore not classified as irritant (UN GHS no category).
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