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EC number: 289-108-9 | CAS number: 86014-62-2
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 January 2017 to 10 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidleines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ammonium mono(2- ethylhexyl)phosphate
- Molecular formula:
- C8H22NO4P
- IUPAC Name:
- Ammonium mono(2- ethylhexyl)phosphate
- Reference substance name:
- Ammonium bis(2-ethylhexyl) phosphate
- EC Number:
- 225-615-3
- EC Name:
- Ammonium bis(2-ethylhexyl) phosphate
- Cas Number:
- 4971-47-5
- Molecular formula:
- C16H38NO4P
- IUPAC Name:
- Ammonium bis(2- ethylhexyl)phosphate
- Reference substance name:
- 2-ethylhexyl diphosphate ammonium salts / esters of 2-ethylhexan-1-ol with diphosphoric acid and their corresponding ammonium salts
- Molecular formula:
- C8H23NO7P2
- IUPAC Name:
- 2-ethylhexyl diphosphate ammonium salts / esters of 2-ethylhexan-1-ol with diphosphoric acid and their corresponding ammonium salts
- Test material form:
- liquid
- Details on test material:
- Storage Conditions: Room temperature.
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerated 2 - 8 ºC
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: n/a
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: In order to assess the potential non-specific reduction of the test article, 50 µL of test article was added to 1 mL of 1.0 mg/mL MTT and the colour change was assessed after incubation for 60 minutes at 37 ± 1 ºC, 5 ± 1% CO2, 95 % RH. There was no change in colour therefore the test article was deemed not to interact with MTT.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Warmed to 37 ºC to enable easier pipetting of the viscous test item.
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: n/a
- Final preparation of a solid: n/a
FORM AS APPLIED IN THE TEST (if different from that of starting material): Applied as supplied - viscous liquid.
OTHER SPECIFICS: n/a
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: reconstructed epidermis with a functional stratum corneum supplied by MatTek In Vitro Life Science Laboratories, Bratislava, Slovak Republic
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM Reconstructed Human Epidermis
- Tissue batch number(s): 00267; EpiDerm RHE kit lot #: 23338
- Production date: Not reported
- Shipping date: Not reported
- Delivery date: Not reported
- Date of initiation of testing: 18 January 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Not reported
- Temperature of post-treatment incubation (if applicable): 37 ± 1 ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Rinsed with PBS, volume not reported.
- Observable damage in the tissue due to washing: Not reported, assume 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: Yes, details not reported
- Wavelength: 570 nm
- Filter: No / not reported
- Filter bandwidth: No / not reported
- Linear OD range of spectrophotometer: Not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: acceptable (reported in CoA)
- Barrier function: acceptable (reported in CoA)
- Morphology: acceptable (reported in CoA)
- Contamination: acceptable (reported in CoA)
- Reproducibility: COV of mean replicated was <30 %.
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Freeze killed tissues
- Procedure used to prepare the killed tissues (if applicable): Not reported
- No. of replicates : 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure 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 431 and 439: n/a - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): n/a
VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): n/a
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8 N - Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Duration of post-treatment incubation (if applicable):
- incubated in MTT medium for 3 hours and followed by an overnight extraction in isopropanol.
- Number of replicates:
- 2 for each timepoint
Test animals
- Species:
- other: n/a
- Strain:
- other: n/a
- Details on test animals or test system and environmental conditions:
- n/a
Test system
- Type of coverage:
- other: n/a
- Preparation of test site:
- other: n/a
- Vehicle:
- other: n/a
- Amount / concentration applied:
- n/a
- Duration of treatment / exposure:
- n/a
- Observation period:
- n/a
- Number of animals:
- n/a
- Details on study design:
- n/a
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 repeat - 3 min exposure
- Value:
- 79
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100 % viability (OD 1.221)
- Positive controls validity:
- valid
- Remarks:
- 4 % viability
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 repeat - 60 min exposure
- Value:
- 17.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100 % viability (OD 1.394)
- Positive controls validity:
- valid
- Remarks:
- 0 % viability
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
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
- Range of historical values if different from the ones specified in the test guideline: n/a
Any other information on results incl. tables
Table 2: Mean OD570Values and Viabilitiesfor the Negative Control Item, Positive Control Item and Test Item (Repeat Experiment 1)
Tissue |
Exposure Period |
MeanOD570 of individual tissues |
Mean OD570 of duplicate tissues |
Standard Deviation |
Coefficient of Variation (%) |
Relative Mean Viability (%) |
Negative Control |
3 Minutes |
1.190 |
1.221 |
0.040 |
3.2 |
100* |
1.252 |
||||||
60 Minutes |
1.532 |
1.394 |
nd |
10.9 |
||
1.256 |
||||||
Positive Control |
3 Minutes |
0.296 |
0.301 |
0.028 |
8.0 |
4.0 |
0.305 |
||||||
60 Minutes |
0.127 |
0.128 |
nd |
4.9 |
-0.8 |
|
0.130 |
||||||
Test Item |
3 Minutes |
1.140 |
0.962 |
0.196 |
20.4 |
79 |
0.783 |
||||||
60 Minutes |
0.277 |
0.243 |
nd |
15.6 |
17.5 |
|
0.210 |
OD = Optical density
*= The mean % viability of the negative control tissue is set at 100 %
nd= Not determined
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test substance is not considered to be corrosive in the in vitro skin corrosion test using the EpiDerm Skin Model.
- Executive summary:
OECD 431 (2017) - The skin corrosivity potential of reaction mass of ammonium mono(2 ethylhexyl)phosphate, ammonium bis(2 ethyl hexyl)phosphate and 2 -ethylhexyl diphosphate ammonium salts was assessed using an EpiDerm Reconstructed Human Epidermis (RHE) Model Kit in accordance with OECD guidance 431 and GLP.
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 mins. At the end of the exposure period the test item was rinsed from each tissue before being loaded with MTT. After MTT loading each tissue was placed in 2 mL isopropanol for MTT extraction. After extraction, each tissue was pierced and the extraction solution aliquoted for absorbance measurements. Absorbency at 570 nm of each well was measured using a spectrophotometer.
Mean viability of tissues exposed to the test substance after 3 and 60 minutes were 79 % and 17.5 %, respectively. The quality criteria required for acceptance of the resuts was met.
Under the conditions of this study the test substance is not considered to be corrosive to the skin.
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