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EC number: 947-359-8 | 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:
- From October 02, 2017 to October 06, 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 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:
- other: EU B.40 BIS "In Vitro Skin Corrosion: Human Skin Model Test
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phosphoric acid, C6-12-alkyl esters, potassium salts
- EC Number:
- 291-900-4
- EC Name:
- Phosphoric acid, C6-12-alkyl esters, potassium salts
- Cas Number:
- 90506-39-1
- Molecular formula:
- UVCB
- IUPAC Name:
- potassium decyl octyl phosphate
- Test material form:
- solid
- Details on test material:
- Appearance: White solid
Batch: RE 14-6
Constituent 1
- Specific details on test material used for the study:
- Chemical name (IUPAC), synonym or trade name: Phosphoric acid, mono- and di-C6-12-(even numbered)-alkyl esters, potassium salts
Appearance: White solid
Batch: RE 14-6
Purity/Composition: UVCB
Test substance storage: At room temperature
Stable under storage conditions until: 27 July 2018 (expiry date)
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm Skin Model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Justification for test system used:
- 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. Recommended test system in international guidelines (OECD and EC)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- 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. The plates were incubated for approximately 3 hours at 37.0 ± 1.0ºC. The medium was replaced with fresh DMEM just before the test item 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 the test item and two for a 1-hour exposure. 50 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.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3 minutes and 1 h
- Number of replicates:
- 4 tissues per test susbtance two tissues were used for a 3-minute exposure and two for a 1-h exposure.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: remaining cell viability after exposure to the test item
- Run / experiment:
- 3 minutes
- Value:
- ca. 88
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- other: remaining cell viability after exposure to the test substance
- Run / experiment:
- 1 h
- Value:
- ca. 106
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Test substance was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the test item did not interfere with the MTT endpoint.
The mean absorption at 570 nm measured after treatment with the test substance and controls are presented in Table 1 in below sections. The individual OD570 measurements are presented in table 2.
Table 3 shows the mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 88% and 106% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive.
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. The mean relative tissue viability following the 1-hour exposure to the positive control was 7.4%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was < 16%, indicating that the test system functioned properly.
Any other information on results incl. tables
Table1: Mean Absorption in thein vitro skin corrosion test with test substance
|
3-minute application |
1-hour application |
||||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
|||
Negative control |
1.810 |
2.167 |
1.988 |
± |
0.253 |
1.822 |
1.893 |
1.857 |
± |
0.050 |
Test item |
1.791 |
1.696 |
1.744 |
± |
0.067 |
2.082 |
1.842 |
1.962 |
± |
0.170 |
Positive control |
0.508 |
0.158 |
0.333 |
± |
0.247 |
0.156 |
0.117 |
0.137 |
± |
0.028 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0431). Isopropanol was used to measure the background absorption.
Table 2: Individual OD Measurements at 570 nm
|
3-minute application (OD570) A B |
1-hour application (OD570) A B |
||
Negative control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
1.8603 |
2.2101 |
1.8066 |
1.9555 |
|
1.8617 |
2.2242 |
1.9189 |
1.9235 |
|
1.8367 |
2.1960 |
1.8688 |
1.9290 |
|
Test item OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
1.8565 |
1.7476 |
2.1751 |
1.8878 |
|
1.8369 |
1.7341 |
2.1298 |
1.8969 |
|
1.8095 |
1.7360 |
2.0712 |
1.8701 |
|
Positive control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
0.5508 |
0.2007 |
0.2011 |
0.1605 |
|
0.5511 |
0.2017 |
0.1988 |
0.1604 |
|
0.5525 |
0.2020 |
0.1984 |
0.1601 |
OD = Optical density
Duplicate exposures are indicated by A and B.
Table 3: Mean Tissue viability in the in vitro skin corrosion test with test substance
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
|
Negative control |
100 |
100 |
Test item |
88 |
106 |
Positive control |
17 |
7.4 |
Table 4: Coefficient of variation
between tissue replicates
|
3 minute |
1 hour |
Negative control |
16 |
3.8 |
Test item |
5.3 |
12 |
Positive control |
69 |
25 |
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the study conditions, the test substance was considered to be non- corrosive to human-derived epidermal keratinocytes (EpiDerm Skin Model).
- Executive summary:
A study was conducted to determine the in vitro skin corrosion potential of the test substance, according to OECD Guideline 431and EU Method B.40 BIS: "In VitroSkin Corrosion: Human Skin Model Test (EpiDerm Skin Model)in compliance with GLP. The test substance was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the test item did not interfere with the MTT endpoint. Duplicates were exposed to test substance for 3 minutes and 1 hour. Post treatment period, a determination of the cytotoxic effect was performed. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin corrosion was expressed as the remaining cell viability after exposure to the test substance. The positive control had a mean relative tissue viability of 7.4% 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 ≤16%, indicating that the test system functioned properly. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test substance compared to the negative control tissues was 88% and 106%, respectively.Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive. Under the study conditions, the test substance was considered to be non- corrosive to human-derived epidermal keratinocytes (EpiDerm Skin Model) (Groot, 2017).
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