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EC number: 224-305-5 | CAS number: 4297-95-4
- 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
- Remarks:
- The Reconstructed human Epidermis (RhE) Test Method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Phase scheduled: 01. Apr. 2019 - 17. May. 2019 Final Report: Jun. 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 423 / EU B.1 trans
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD (2015)
- Deviations:
- not applicable
- Remarks:
- Interruption of the power supply. Temperature dropped to 32°C and CO2 conc. dropped to 3%. This is uncritical: values outside the range were short term - no abnormalities. The deviation was assessed and signed by the study director on 10. Apr. 2019.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium phenylphosphinate
- EC Number:
- 224-305-5
- EC Name:
- Sodium phenylphosphinate
- Cas Number:
- 4297-95-4
- Molecular formula:
- C6H7O2P.Na
- IUPAC Name:
- sodium phenylphosphinate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test Item
Designation in Test Facility: 19022101G
Date of Receipt: 21. Feb. 2019
Specification
The following information concerning identity and composition of the test item is provided by the sponsor.
Name Sodium phenylphosphinate
Batch no. 20190104
Appearance white powder
Composition approx. 98 % Sodium phenylphosphinate, approx. 1.5 % phenylphosphonic acid, approx. 0.5 % others
Purity 98%
Homogeneity homogeneous
Expiry date 15. Jan. 2020
Storage Room Temperature (20 ± 5°C)
The following additional information, also provided by the sponsor, is relevant to the con-duct of the study, according to OECD 439:
CAS No. 4297-95-4
EC-No. 224-305-5
Condition at Receipt Room temperature, in proper conditions
Stability in solvents H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Solubility H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Structural Formula/
SMILES Code not stated
Storage
The test item will be stored in the test facility in a closed vessel at room temperature (20±5°C).
Negative Control
“Dulbecco’s Phosphate Buffered Saline” (DPBS buffer without CaCl2 and without MgCl2).
Procured from MatTek In Vitro Life Science Laboratories and/or prepared by LAUS GmbH.
Composition:
KCl 0.2 g
KH2PO4 0.2 g
NaCl 8.0 g
Na2HPO4 * 7H2O 2.16 g
H2O ad 1 L
Note: different salts (crystal water) may be used; molar composition will be the same.
Positive Control
Sodium dodecyl sulphate, (SDS), CAS-No. 151-21-3, solution in H2O demin., concentra-tion 50 g/L.
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDermTM procured by MatTek
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Mlynské Nivy 73, Bratislava - Slovakia
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Designation of the kit: EPI-200-SIT
Day of delivery: 02. Apr. 2019
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It con-sists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on spe-cially prepared cell culture inserts
Batch no.: 28690 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 μL
- Concentration (if solution):
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution):5% - Duration of treatment / exposure:
- 35 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours and 20 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test consists of a topical exposure of the neat test item to RhE model followed by cell viability test. Cell viability is measured by dehydrogenase conversion of MTT into a blue formazan salt that is quantitatively measured after extraction from tissues.
- Value:
- 87.2
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- 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:
- Therefore, the test item Sodium phenylphosphinate is considered
non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method. - Executive summary:
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 1.9.
The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.6% (required: 20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%).
The mean value of relative tissue viability of the test item was reduced to 87.2% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.
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