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EC number: 610-104-3 | CAS number: 43100-47-6
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study according to guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- EpiDerm(TM)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE
Test material
- Reference substance name:
- 3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol
- EC Number:
- 610-104-3
- Cas Number:
- 43100-47-6
- Molecular formula:
- C39 H29 F3 O2
- IUPAC Name:
- 3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Ligand TFME-DPP
- Physical state: solid, white
- Batch No.: 01829-00216
- pH: Ca. 5 (undiluted test substance, moistened with water)
- Storage condition of test material: at room temperature
- Homogeneity: Homogenous by visual inspection
Constituent 1
Test animals
- Species:
- other: not applicable (in vitro test)
- Strain:
- other: not applicable (in vitro test)
Test system
- Type of coverage:
- other: not applicable (in vitro test)
- Preparation of test site:
- other: not applicable (in vitro test)
- Vehicle:
- physiological saline
- Controls:
- other: not applicable (in vitro test)
- Amount / concentration applied:
- negative control tissues: 30 ul PBS
positive control tissues: 30 ul 5% SDS
test tissues: 25 ul PBS + 25 ul solid test material - Duration of treatment / exposure:
- 1 hour (25 min at room temperature + 35 min at 37°C), then tissues were washed with sterile PBS, transferred into fresh medium and dried with a sterile cotton swab
- Observation period:
- 42 hours (2nd medium change at 24 +/- 2 hours after exposure)
- Number of animals:
- not applicable (in vitro test)
For negative control, positive control and test substance, three tissues each were employed. Additionally, one killed tissue each was used for the test substance and negative control in order to detect direct MTT reduction - Details on study design:
- The EpiDerm(TM) Skin Irritation Test is based on the finding that chmical-induced skin irritation is the result of a cascade of events that is initiated by penetration of the chemicals through the stratum corneum where they may damage the underlying layers of keratinocytes and other skin cells. The test method used here measures the initiating event in the cascade, i.e. cell / tissue damage. This is accomplished via the means of the vital dye MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide]. Living cells convert MTT enzymatically into blue formazan salt which is quantitatively measured after extraction from tissues.
EpiDerm(TM) consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. Based on the results of a validation study, it was concluded by EVCAM that the EpiDerm(TM) human epidermis model is suitable to be used for distinguishing between irritant and non-irritant chemicals.
To determine whether Ligand TFME-DPP constitutes a skin irritant, EpiDerm tissues were preincubated for 16-22 hours in 0.9 mL medium and subsequently treated with the test substance, the positive control or the negative control. For test substance treatment, 25 ul of PBS were added first. Thereafter, a bulk volume of 25 ul of the solid test material (ca. 12 mg) was applied with a sharp spoon and homogeneously distributed together with the fluid. Control tissues were concurrently applied with 30 ul of sterile PBS (negative control, NC) or with 30 ul of 5 % SDS (positive control, PC). A nylon mesh was placed carefully onto the tissue surface of the NC and PC controls afterwards.
Following incubation for 25 min at room temperature and 35 min at 37°C, the tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted onto sterile absorbent paper and transferred into new 6-well-plates, pre-filled with 0.9 mL fresh medium. When all tissues were rinsed, the surface of each tissue was carefully dried with a sterile cotton swab. The tissues were then incubated at 37°C for 24 +/- 2 hours, subsequently transferred into new 6-well plates pre-filled with 0.9 mL fresh medium and incubated at 37°C for additional 18 +/- 2 hours.
The medium was then replaced by 0.3 mL MTT solution and the tissues were incubated at 37°C for 3 hours. They were then washed with PBS to stop the MTT-incubation. The formazan salt was extracted with isopropanol from the tissues and the optical density was determined spectrophotometrically. The quotient of test tissue absorption divided by negative control absorption was used to calculate tissue viability.
Results and discussion
Any other information on results incl. tables
Preliminary findings indicated that the test substance can reduce MTT directly. Therefore, killed control tissues treated as negative control were performed in parallel. However, the result of the killed control did not indicate an increased MTT reduction, therefore the killed control was not used for viability calculation.
The EpiDerm(TM) in vitro skin irritation test showed no reduction in cell viability after treatment with test substance compared to negative control (115% and 100%, respectively). In contrast, mean viability of the positive control was 4%.
tissue 1 | tissue 2 | tissue 3 | mean | SD | ||
Negative control (NC) | mean OD(570) | 2.160 | 2.206 | 2.317 | 2.228 | |
viability (% of NC) | 97.0 | 99.0 | 104.0 | 100 | 3.62 | |
Test substance | mean OD(570) | 2.608 | 2.645 | 2.420 | 2.558 | |
viability (% of NC) | 117.1 | 118.7 | 108.7 | 115 | 5.4 | |
Positive control | mean OD(570) | 0.082 | 0.081 | 0.072 | 0.079 | |
viability (% of NC) | 3.7 | 3.7 | 3.2 | 4 | 0.25 |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.