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EC number: 271-708-7 | CAS number: 68604-99-9
- 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:
- weight of evidence
- Study period:
- 12.07.2017-06.09.2017
- 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: Human Skin Model Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-(dimethoxyphosphoryl)octadecanoic acid 10-(dimethoxyphosphoryl)octadecanoic acid
- Molecular formula:
- C20H41O5P
- IUPAC Name:
- 9-(dimethoxyphosphoryl)octadecanoic acid 10-(dimethoxyphosphoryl)octadecanoic acid
- Reference substance name:
- 9,12-bis(dimethoxyphosphoryl)octadecanoic acid 9,13-bis(dimethoxyphosphoryl)octadecanoic acid 10,12-bis(dimethoxyphosphoryl)octadecanoic acid 10,13-bis(dimethoxyphosphoryl)octadecanoic acid
- Molecular formula:
- C22H46O8P2
- IUPAC Name:
- 9,12-bis(dimethoxyphosphoryl)octadecanoic acid 9,13-bis(dimethoxyphosphoryl)octadecanoic acid 10,12-bis(dimethoxyphosphoryl)octadecanoic acid 10,13-bis(dimethoxyphosphoryl)octadecanoic acid
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Reference substance name:
- Linoleic acid
- EC Number:
- 200-470-9
- EC Name:
- Linoleic acid
- Cas Number:
- 60-33-3
- Molecular formula:
- C18H32O2
- IUPAC Name:
- octadeca-9,12-dienoic acid
- Reference substance name:
- Dimethyl (2-oxopropyl)phosphonate
- EC Number:
- 224-110-5
- EC Name:
- Dimethyl (2-oxopropyl)phosphonate
- Cas Number:
- 4202-14-6
- Molecular formula:
- C5H11O4P
- IUPAC Name:
- dimethyl (2-oxopropyl)phosphonate
- Reference substance name:
- Dimethyl propylphosphonate
- EC Number:
- 242-555-3
- EC Name:
- Dimethyl propylphosphonate
- Cas Number:
- 18755-43-6
- Molecular formula:
- C5H13O3P
- IUPAC Name:
- dimethyl propylphosphonate
- Reference substance name:
- Dimethyl methylphosphonate
- EC Number:
- 212-052-3
- EC Name:
- Dimethyl methylphosphonate
- Cas Number:
- 756-79-6
- Molecular formula:
- C3H9O3P
- IUPAC Name:
- dimethyl methylphosphonate
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
- Specific details on test material used for the study:
- IDENTIFICATION OF THE TEST MATERIAL
- Identification: Fatty acids, C18-unsatd., phosphates.
- CAS number: 68604-99-9
- EC number: 271-708-7
- Appearance: Yellow liquid
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0101891886
- Expiration date of the lot/batch: 02 November 2017
- Purity test date: 100% UVCB
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: No specific handling conditions required
- Solubility and stability of the test substance in the solvent/vehicle: no
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not expected
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 25 μl of the undiluted test item was added into 12-well plates on top of the skin tissues.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm Skin Model (EPI-200, Lot no.: 26708 Kit L and M). The model consists of normal, human-derived epidermal keratinocytes which have been
cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum
containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of
10 mm cell culture inserts.
The skin tissues were kept in the refrigerator the day they were received. The next day, at
least 1 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 (see
figure 1). The plates were incubated for approximately 2.5 hours at 37.0 ± 1.0ºC. The
medium was replaced with fresh DMEM just before C18-unsatd., phosphates. was applied.
The test was performed on a total of 4 tissues per test item together with a negative control
and positive control. Two tissues were used for a 3-minute exposure to C18-unsatd.,
phosphates. and two for a 1-hour exposure. Fifty μl of the undiluted test item was added into
the 6-well plates on top of the skin tissues.
For the negative and positive controls, 2 tissues were treated with 50 μl Milli-Q water
(negative control) and 2 tissues were treated with 50 μl 8N KOH (positive control) for both
the 3-minute and 1-hour time point.
After the exposure period, the tissues were washed with phosphate buffered saline (Invitrogen
Corporation, Breda, The Netherlands) to remove residual test item. The skin inserts were
carefully dried. Rinsed tissues were kept in 24 well plates on 300 μl DMEM until 6 tissues
(= one application time) were dosed and rinsed.
4.7.5. Cell Viability Measurement
The DMEM was replaced by 300 μl MTT-medium and tissues were incubated for 3 hours at
37°C in air containing 5% CO2. After incubation the tissues were washed with PBS and
formazan was extracted with 2 ml isopropanol (MatTek corporation) over night at room
temperature. The amount of extracted formazan was determined spectrophotometrically at
570 nm in triplicate with the TECAN Infinite® M200 Pro Plate Reader. - 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
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 μl
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 μl
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 3-minute and 1-hour time points.
- Number of replicates:
- 2
Test system
- Amount / concentration applied:
- Amount(s) applied (volume or weight): 25 μl
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 μl
- Concentration (if solution): 5%
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 6.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: The test item was checked for possible direct MTT reduction before the study was started. To assess the ability of the test item to reduce MTT, at least 25 μl of the test item was added to 2 ml MTT solution (0.3 mg/ml in PBS). The mixture was incubated for 3 hours at 37°C. A negative control, sterile Milli-Q water was tested concurrently. At the end of the incubation period a color check was performed. No color change were observed.
- Colour interference with MTT: The test item was checked for possible color interference before the study was started. Some non-colored test items may change into colored items in aqueous conditions and thus stain the skin tissues during the exposure. To assess the color interference, 10 μl of the test item was added to 90 μl Milli-Q water. The mixture was mixed for approximately 15 minutes. A negative control, 10 μl Milli-Q water was tested concurrently. At the end of the shaking period a color check was performed. No color changes were observed.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 6.8%. The absolute mean OD570(optical density at 570 nm) of the three tissues of the negative control should reasonably be within the laboratory historical control data range.
- Acceptance criteria met for positive control: the positive control had a mean cell viability of 16% after 15 ± 0.5 minutes exposure. The mean relative tissue viability of the positive control should be <=50% relative to the negative control.
- Acceptance criteria met for variability between replicate measurements: The standard deviation value of the percentage viability of three tissues treated identically was less than 12%. The SD calculated from individual % tissue viabilities of the three identically treated replicates should be <=18.
Any other information on results incl. tables
Table 1. Mean absorption in the in vitro skin corrosion test with C18 -unsatd. phosphates. 3 -minute application
A(OD570) | B(OD570) | Mean (OD570) | SD | |
Negative control | 1.692 | 1.836 | 1.764 | +-0.102 |
Test item | 1.464 | 1.647 | 1.555 | +-0.129 |
Positive control | 0.115 | 0.135 | 0.125 | +-0.014 |
SD= standard deviation, Duplicate exposures are indicated by A and B |
Table 2. Mean tissue viability in the in vitro skin corrosion test with C18 -usatd. phosphates, 1 -hour application
A(OD570) | B(OD570) | Mean (OD570) | SD | |
Negative control | 1.702 | 1.566 | 1.634 | +-0.096 |
Test item | 0.090 | 0.106 | 0.098 | +-0.011 |
Positive control | 0.188 | 0.153 | 0.171 | +-0.025 |
Table 3. Mean tissue vability in the in vitro skin corrosion test with C18 -usatd. phosphates.
3-minute application viability (percentage of control) | 1-hour application viability (percentage of control) | |
Negative control | 100 | 100 |
Test item | 88 | 6.0 |
Positive control | 7.1 | 10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- In conclusion, C18-unsatd., phosphates. is corrosive in the in vitro skin corrosion test under the experimental conditions described.
- Executive summary:
The objective of this study was to evaluate C18-unsatd., phosphates. for its ability to induce skin corrosion on on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of C18-unsatd., phosphates. was tested through topical application for 3 minutes and 1 hour. The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch 0101891886 of C18-unsatd., phosphates. was a yellow liquid. C18-unsatd., phosphates. was applied undiluted (50 μl) was applied directly on top of the skin tissue. The positive control had a mean relative tissue viability of 10% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit 2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was 11%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with C18-unsatd., phosphates. compared to the negative control tissues was 88% and 6.0%, respectively. Because the mean relative tissue viability for C18-unsatd., phosphates. was below 15% after the 1-hour treatment it is considered to be corrosive. Subsequently, after 3 -min exposure the mean tissue viability was above 25%. In conclusion, C18-unsatd., phosphates. is corrosive, category 1B in the in vitro skin corrosion test under the experimental conditions described.
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