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Diss Factsheets
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EC number: 241-782-5 | CAS number: 17814-85-6
- 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:
- 22 Jan - 13 Feb 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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:
- Updated Guideline adopted July 29, 2016
- Deviations:
- yes
- Remarks:
- In Step 1 of the test for colour interference the incubation time of the mixture with test item and isopropanol was 1 hour instead of 2-3 hours. This deviation was considered to have not affected the integrity or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (4-carboxybutyl)triphenylphosphonium bromide
- EC Number:
- 241-782-5
- EC Name:
- (4-carboxybutyl)triphenylphosphonium bromide
- Cas Number:
- 17814-85-6
- Molecular formula:
- C23H24BrO2P
- IUPAC Name:
- (4-carboxybutyl)triphenylphosphonium bromide
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not reported
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 25 μL of deionised water were applied onto the surface of duplicate EpiDerm™ tissue
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
- Tissue lot number: 30847
- Delivery date: 11 February 2020
- Date of initiation of testing: 13 February 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 20
- 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: microplate reader (Versamax®, Molecular Devices, SoftMax Pro Enterprise (version 4.7.1))
- Wavelength: 570 nm
- Filter: none
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
Specification: MTT QC assay, 4 h, n= 3
Acceptance criteria: OD (540-570 nm) <1.0 - 3.0>
Result and QA Statement: 1.968 ± 0.158 (Pass)
- Barrier function:
Specification: ET-50 assay, 100 µL 1% Triton X-100, 4 time points, n = 3, MTT assay
Acceptance criteria: ET-50 <5.77 - 8.72 h>
Result and QA Statement: 5.05 h (Pass)
- Morphology: Tissue viability and the barrier function test are within the acceptable ranges and indicate appropriate formation of the epidermal barrier, the presence of a functional stratum corneum, a viable basal cell layer, and intermediate spinous and granular layers.
- Contamination:
Specification: Long-term antibiotic and antimycotic free culture
Acceptance criteria: No contamination
Result and QA Statement: Sterile (Pass)
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 ± 2 mg
NEGATIVE CONTROL
- Amount(s) applied: 50 μL Dulbecco's Phosphate-Buffered Saline (DPBS) (MatTek), Batch 112719 ISE
POSITIVE CONTROL
- Amount(s) applied: 50 μL 8.0 N Potassium Hydroxide (KOH, Honeywell), Batch H3410 - Duration of treatment / exposure:
- 3 and 60 min
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure, mean of 2 replicates
- Value:
- 100.72
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100% tissue viability
- Positive controls validity:
- valid
- Remarks:
- 12.65% tissue viability
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure, mean of 2 replicates
- Value:
- 24.58
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100% tissue viability
- Positive controls validity:
- valid
- Remarks:
- 1.75% tissue viability
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: The test facility has been certified to demonstrate proficiency in the EpiDerm Skin Corrosion Test (OECD TG 431) by
- correct prediction of the corrosive potential of the proficiency chemicals
- correct assignment of the chemicals into the sub-classes of corrosiveness as defined by the OECD TG 431 (i.e. 1A vs 1BC merged)
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is considered to be non-corrosive to skin according to EU CLP and UN GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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