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EC number: 234-028-1 | CAS number: 10497-05-9
- 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
Endpoint summary
Administrative data
Description of key information
Skin Corrosion: Category 1(OECD431/GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted: 14 June 2019 (OECD, 2019)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
supplied by Sponsor /Batch number:N200611031
- Purity, including information on contaminants, isomers, etc.: >=98.50%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigeration (+2 to +8°C) - Test system:
- human skin model
- Source species:
- other: a three dimensional Reconstructed Human Epidermis model
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: cultured on a collagen matrix at the air liquid interface
- Justification for test system used:
- The assessment of skin corrosivity has typically involved the use of laboratory animals (OECD TG 404). In relation to animal welfare concerns, TG 404 recommends the use of a tiered testing strategy for the determination of skin corrosion and irritation which includes the use of validated in vitro or ex vivo test methods avoiding pain and suffering of animals.
One of the validated in vitro test methods adopted by the OECD TG 431 makes use of reconstructed human epidermis (RhE). The test is designed to predict and classify the skin corrosivity potential of a test item by assessment of its effect on a reconstituted human epidermis, based on the experience that corrosive substances show cytotoxic effects following short-term exposure of the stratum corneum of the epidermis. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: at room temperature
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
After the respective incubation periods, at room temperature, the epidermis units were removed from the wells and thoroughly rinsed with PBS placed on an absorbent paper to remove excess PBS. The epidermis units were then placed in a 12-well plate filled with 2 mL pre-warmed assay medium to rinse.
After rinsing, each of these epidermal units was gently tapped on an absorbent paper to remove excess assay medium.
DYE BINDING METHOD
- Dye used in the dye-binding assay: [ MTT ]
- Spectrophotometer: Microplate reader Flex Station
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
< 35 % after 3 min exposure Corrosive • Optional sub-category 1A*
≥ 35 % after 3 min exposure AND < 35 % after 60 min exposure OR ≥ 35 % after 60 min exposure AND < 35 % after 240 min exposure Corrosive • A combination of optional Sub-categories 1B and 1C
≥ 35 % after 240 min exposure Non-Corrosive - 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): 50 μL
- Concentration (if solution): Sodium chloride (NaCl) 0.9% (w/v)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL - Duration of treatment / exposure:
- 240 mins
- Duration of post-treatment incubation (if applicable):
- 3 hour
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 8.05
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: Since, the color of MTT solution did not turn to either blue or purple, it was concluded that, the test item did not interact with MTT.
- Colour interference with MTT: Similarly, the water control tested did not show any coloring potential nor did it reduce the MTT.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: It is considered that the NC meets the acceptance, if the mean OD value of the 2 tissues is ≥ 0.6 and ≤ 1.5 for every exposure time.
- Acceptance criteria met for positive control: It is considered that the Positive Control (glacial Glacial acetic acid) meets the acceptance if the mean viability expressed as % of the NC, is ≤ 20%.
- Acceptance criteria met for variability between replicate measurements: the difference of viability between the two tissue replicates should not exceed 30% - Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The tissue viability is < 35% after the 60 and 240 minutes exposure, the test item Tris(trimethylsilyl) phosphate is predicted to be corrosive under the experimental conditions described in the report.
- Executive summary:
In a in vitro skin corrosion study ( G20748) according to OECD 431 TG under GLP compliance, a three dimensional Reconstructed Human Epidermis model were exposed to 50 μL of Tris(trimethylsilyl) phosphate for 3, 60 and 240 minutes. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the respective treatment periods with the test item was compared to the negative control tissues.
The relative mean tissue viability obtained after 3, 60 and 240 minutes treatment duration with the test item compared to the negative control tissues was 98.79, 12.54 and 8.05 %, respectively.The positive control had a mean cell viability of 6.23 % after 240 minutes exposure. The absolute mean OD570of the negative control tissues was within the laboratory historical control data range.
In this study, the test item Tris(trimethylsilyl) phosphate is classified as skin corrosive category1 based on GHS criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The skin corrosion potential of Tris(trimethylsilyl) phosphate has been evaluated in one in vitro skin corrosion test using Reconstructed Human Epidermis (RhE) as the test system.
In a in vitro skin corrosion study ( G20748) according to OECD 431 TG under GLP compliance, a three dimensional Reconstructed Human Epidermis model were exposed to 50 μL of Tris(trimethylsilyl) phosphate for 3, 60 and 240 minutes. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the respective treatment periods with the test item was compared to the negative control tissues.
The relative mean tissue viability obtained after 3, 60 and 240 minutes treatment duration with the test item compared to the negative control tissues was 98.79, 12.54 and 8.05 %, respectively.The positive control had a mean cell viability of 6.23 % after 240 minutes exposure. The absolute mean OD570of the negative control tissues was within the laboratory historical control data range.
In this study, the test item Tris(trimethylsilyl) phosphate is classified as skin corrosive category1 based on GHS criteria.
Eye irritation:
There is no such a study to evalute the eye irritaion potential of Tris(trimethylsilyl) phosphate as it has been waiverd due to the corrision property of the test item.
Justification for classification or non-classification
Based on the available information in the dossier, the substance Tris(trimethylsilyl) phosphate (CAS No.10491-05-9) needs to be classified for skin corrosion Category 1 and eye damage Category 1 when considering the criteria outlined in Annex I of 1272/2008/EC.
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