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EC number: 948-935-1 | CAS number: -
- 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:
- 06 February 2019 - 08 February 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test". Official Journal of the European Union No. L142,
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phosphonic acid, P-octadecyl-, dibutyl ester
- EC Number:
- 846-068-2
- Cas Number:
- 52235-56-0
- Molecular formula:
- C26 H55 O3 P
- IUPAC Name:
- Phosphonic acid, P-octadecyl-, dibutyl ester
- Test material form:
- liquid
- Details on test material:
- Physical Description: Clear solution
Storage Conditions: At room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): 29944, Kit I and J
- Surface: 0.6 cm^2
- Pretreatment: The tissues were kept on agarose and stored in the refrigerator on the day they were received. The next day, at least one hour before the assay was started the tissues were transferred to 6-well plates containing 0.9 ml DMEM per well. The level of the DMEM was just beneath the tissue. The plates were incubated for approximately one hour at 37.0 ± 1.0ºC. The medium was replaced with fresh DMEM just before X-20777 was applied.
INTERFERENCE WITH THE MTT ENDPOINT:
- Test for color interference by the test item: 50 μL test item was added to 0.3 mL Milli-Q water and the mixture was incubated for approx. one hour at 37.0 ± 1.0°C in the dark. At the end of the exposure time the mixture was shaken and it was checked if a blue/purple color change was observed. A negative control (Milli-Q water) was tested concurrently.
- Test for reduction of MTT by the test item: 50 μL of the test item was added to 1 mL MTT solution (1 mg/mL) in phosphate buffered saline. The mixture was incubated for approx. one hour at 37.0 ± 1.0°C. At the end of the exposure time it was checked if a blue/purple color change was observed or a blue/purple precipitate was observed. A negative control (Milli-Q water) was tested concurrently.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment of 3 minutes: room temperature
- Temperature of 1 hour and post-treatment incubation: 37.2 - 37.5°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: after exposure and after incubation tissues were washed with phosphate buffered saline
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Amount of MTT-medium: 300 μL
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: two tissues treated with test item + two replicates for the negative control and the positive control per exposure duration
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one experiment per exposure period (two in total) with 3 independent OD570 measurements per replicate.
ACCEPTABILITY CRITERIA
The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
- The absolute mean OD570 of the two tissues of the negative control should reasonably be within the laboratory historical control data range.
- The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
- In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%.
DECISION CRITERIA (see table 1 in 'any other information on materials and methods')
A test item is considered corrosive in the in vitro skin corrosion test if:
- The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
- In addition, a test item considered non-corrosive (viability ≥50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
- The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
- In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 μL
- The test item was applied directly on top of the skin tissues
NEGATIVE CONTROL
- Amount applied: 50 μL (Milli-Q water)
POSITIVE CONTROL
- Amount applied: 50 μL (8N KOH) - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours in MTT medium
- Number of replicates:
- 2 tissues per test item per exposure time (4 tissues in total)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean of 2 replicates
- Run / experiment:
- 3-minute exposure
- Value:
- 87
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean of 2 replicates
- Run / experiment:
- 1-hour exposure period
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - RESULTS
Because the mean relative tissue viability for X-20777 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, X-20777 is considered to be not corrosive.
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS: (see table 2 and 3 in 'any other information on results' for historical data and mean OD570 absorption data.):
- Acceptance criteria met for negative control: yes, the absolute mean OD570 of the two tissues of the negative control was within the laboratory historical control data range (i.e 1.444 and 1.428 for the 3-minute and 1-hour exposure respectively).
- Acceptance criteria met for positive control: yes, the mean relative tissue viability following 1-hour exposure to the positive control was <15 % (i.e. 13%).
- Acceptance criteria met for variability between replicate measurements: yes, the Coefficient of Variation between tissue replicates was ≤30% for the negative control (3-minute: 9.0%; 1-hour: 14%) and test item (3-minute 1.3%).
The acceptance criteria for variability between replicate measurements were not met for the positive control, the Coefficient of Variation between tissue replicates at the 3-minute exposure was 36%. However both individual tissues were clearly positive therefore it was concluded that the test system functioned properly.
Any other information on results incl. tables
Table 1 Decision criteria
Viability measured after 3-minutes and 1 hour |
Prediction to be considered |
Step 1 |
|
< 50% after 3 minute exposure |
Corrosive |
≥ 50% after 3 minute exposure AND < 15% after 1 hour exposure |
Corrosive |
≥ 50% after 3 minute exposure AND ≥ 15% after 1 hour exposure |
Non-corrosive |
Step 2 (for substances/mixtures identified as Corrosive in step 1) |
|
< 25% after 3 minute exposure |
Optional Sub-category 1A |
≥ 25% after 3 minute exposure |
A combination of optional Sub-categories 1B and 1C |
Table 2 Historical control data
|
Negative control |
Positive control |
||
3-minute treatment (OD570) |
1-hour treatment (OD570) |
3-minute treatment (OD570) |
1-hour treatment (OD570) |
|
Range |
1.258 – 2.615 |
1.371 – 2.371 |
0.092 – 0.56 |
0.046 – 0.339 |
Mean |
1.73 |
1.78 |
0.19 |
0.14 |
SD |
0.24 |
0.21 |
0.09 |
0.05 |
n |
116 |
119 |
114 |
112 |
SD = Standard deviation n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of November 2015 to November
Table 3 Mean Absorption in the in vitro Skin Corrosion Test with X-20777
|
3-minute application |
|
1-hour application |
|
||
|
Mean A (OD570) B (OD570) (OD570) |
SD |
Mean A (OD570) B (OD570) (OD570) |
SD |
||
Negative control |
1.376 1.512 |
1.444± |
0.097 |
1.317 1 .539 |
1.428± |
0.157 |
X-20777 |
1.255 1.272 |
1.263± |
0.012 |
1.335 1.345 |
1.340± |
0.007 |
Positive control |
0.512 0.326 |
0.419± |
0.132 |
0.251 0.118 |
0.185± |
0.094 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0463). Isopropanol was used to measure the background absorption.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Study is part of a tiered approach, no conclusion can be drawn for classification on skin corrosion/irritation.
- Conclusions:
- In an in vitro skin corrosion test performed according to OECD 431, X-20777 is found not corrosive to skin. The study is part of a tiered approach, no conclusion can be drawn on classification for skin corrosion/irritation from this study.
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