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EC number: 219-774-8 | CAS number: 2528-39-4
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 - 30 Nov 2016
- 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted July 2015
- Deviations:
- yes
- Remarks:
- no demonstration of the technical proficiency in the report, no information provided regarding functionality of test system, no Coefficient of variation provided in the report, acceptability criteria vary from TG OECD 431
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovak National Accreditation Service, Bratislava, Slovak Republic
Test material
- Reference substance name:
- Trihexyl phosphate
- EC Number:
- 219-774-8
- EC Name:
- Trihexyl phosphate
- Cas Number:
- 2528-39-4
- Molecular formula:
- C18H39O4P
- IUPAC Name:
- trihexyl phosphate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™; reconstructed three-dimensional human epidermis (EPI-200-SCT)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: none specified
- Source strain:
- not specified
- Details on animal used as source of test system:
- TEST SKIN MODEL
- Source: MatTek Corporation's Reconstituted Human Epidermal Model EpiDerm™ (Lot No. 23382), In Vitro Life Science Laboratories, Slovak Republic.
TEST METHOD
The model represents a reconstructed three-dimensional skin model based on normal human-derived epidermal keratinocytes which have been cultured to form a multilayered epidermis including basal, spinous, and granular layers, and a multilayered stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlying cell layers, which is determined through a decrease in cell viability as determined by MTT reduction assay.
ADAPTION TO CELL CULTURE CONDITIONS
- EpiDermTM was delivered one day before the pre-incubation of tissues and was stored in the original package at 2-8°C. At Day 1, each culture was removed with sterile forceps from the agarose gel, inspected and transferred to pre-labeled 6-well plates containing 0.9 mL of assay medium per assay well. The EpiDermTM cultures were incubated at 37±1°C in a humidified atmosphere of 5±1% CO2 in air for 1 hour.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 37±1
- CO2 gas concentration (%): 5
- Humidity: maximum - Justification for test system used:
- This test guideline addresses the human health endpoint skin corrosion. It makes use of reconstructed human epidermis (RhE) obtained from human derived non-transformed epidermal keratinocytes which closely mimics the histological, morphological, biochemical, and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™; reconstructed three-dimensional human epidermis (EPI-200-SCT)
- Tissue batch number(s): lot # 23382
- Production date: none specified
- Delivery date: day before pre-incubation of tissues
- Date of initiation of testing: 29 Nov 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation (if applicable): 37 ± 1°C in humidified atmosphere of 5 ± 1% CO2 in air during incubation with MTT reagent
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: DPBS (20 times: volume not specified)
- Observable damage in the tissue due to washing: none
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: MRX II (Dynex)
- Wavelength: 540 nm
- Filter: no reference filter was used
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- no information given in report
NUMBER OF REPLICATE TISSUES:
- each treatment was conducted in duplicate
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- none were needed as there was no direct reduction of MTT, or test substance colour change
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
- a single experiment was conducted
CELL VIABILITY MEASUREMENTS
- For determining alterations in cell viability, MTT reduction assays were performed. Therefore, the tissues were incubated in 300 µL prewarmed MTT solution for 3 h at 37 ± 1°C and 5% CO2. After aspiration of the MTT solution, tissues were blotted on absorbent paper. Extraction of the formazan product was carried out in 2 mL isopropanol overnight without shaking at room temperature. Each extraction solution in a volume of 200 µL was transferred to a 96-well plate, and absorbances were recorded.
PREDICTION MODEL / DECISION CRITERIA
please refer to Table 1 in "Any other information on materials and methods incl. tables" - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
- Concentration: undiluted
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 100% purified H2O
POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 8N - Duration of treatment / exposure:
- 3 and 60 min
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- of negative control
- Run / experiment:
- test substance, 3 min
- Value:
- ca. 95.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- of negative control
- Run / experiment:
- test substance, 1 h
- Value:
- ca. 97.2
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: mean OD
- Run / experiment:
- test substance, 3 min
- Value:
- ca. 1.595
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: mean OD
- Run / experiment:
- test substance, 1 h
- Value:
- ca. 1.522
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct MTT reduction: no direct MTT reduction by the test substance
- Colour interference with MTT: no coloring potential interference by the test substance
DEMONSTRATION OF TECHNICAL PROFICIENCY: not provided in the report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, as the OD was ≥ 0.8 (1.678 and 1.566 after 3 min and 1 h, respectively)
- Acceptance criteria met for positive control: yes, as the viability was < 15% (7.4% after 1 h)
Any other information on results incl. tables
Table 2: Raw Blank-corrected data after 3 min exposure to negative and positive controls and test substance
Blank-corrected data |
Mean OD |
Viability (%) |
|||
Negative control (H2O) |
1.703 |
1.633 |
1.630 |
1.656 |
98.7 |
1.738 |
1.681 |
1.680 |
1.700 |
101.3 |
|
Positive control (8N KOH) |
0.329 |
0.313 |
0.318 |
0.320 |
19.1 |
0.278 |
0.274 |
0.276 |
0.276 |
16.5 |
|
Test substance |
1.667 |
1.607 |
1.637 |
1.637 |
97.6 |
1.576 |
1.540 |
1.542 |
1.553 |
92.6 |
Table 3: Raw Blank-corrected data after 1 h exposure to negative and positive controls and test substance
Blank-corrected data |
Mean OD |
Viability (%) |
|||
Negative control (H2O) |
1.587 |
1.541 |
1.537 |
1.555 |
99.3 |
1.653 |
1.532 |
1.545 |
1.577 |
100.7 |
|
Positive control (8N KOH) |
0.117 |
0.119 |
0.115 |
0.117 |
7.5 |
0.113 |
0.112 |
0.113 |
0.113 |
7.2 |
|
Test substance |
1.498 |
1.461 |
1.430 |
1.463 |
93.4 |
1.629 |
1.546 |
1.568 |
1.581 |
101.0 |
Table 4: Historical data (from 06/2010 to 10/2013)
Parameter |
Negative control (H2O) [optical density] |
Positive control (8N KOH) [% viability] |
||
3 min |
1 h |
3 min |
1 h |
|
Mean |
1.565 |
1.440 |
18.85 |
11.03 |
SD |
0.07 |
0.04 |
3.54 |
0.92 |
Range |
1.456-1.647 |
1.440-1.817 |
12.7-22.7 |
9.8-12.5 |
Results in this study (600361910) |
1.678 |
1.566 |
17.8 |
7.4 |
The results obtained for the negative and positive controls are slightly out of the historical control data range for the 3 min exposure and the 1 h exposure, respectively, but they lie in the range of the acceptance criteria (please refer to "Any other information on materials and methods incl. tables").
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive (Skin Irrit. 2 or not classified according to Regulation (EC) No 1272/2008)
- Conclusions:
- Under the conditions of the test, the test substance was shown to have no corrosive potential towards reconstructed human epidermis tissue in the EpiDerm™ model. The result does not allow for the non-classification or classification as irritant of the test substance and therefore further evaluation and/or data generation is required.
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