Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Test type:
- acute toxic class method
- Limit test:
- no
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 the test substance used in the study report: Ligand TFME-DPP
- Purity: 94.8 g/100 g
- Test substance No.: 08/0260-1
- Homogeneity: homogeneous by visual inspection
- Physical state: white solid
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 10 – 11 weeks
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 20 – 80%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3 and 20 g/100 ml
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg (gavage)
DOSAGE PREPARATION:
The test-substance preparation was produced for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 300 mg/kg: 3 animals; 2000 mg/kg: 6 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Individual body weight determination shortly before administration (day 0), weekly thereafter and on the last day of observation.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.
- Necropsy of survivors performed: yes
Necropsy with gross-pathology examination on the last day of the observation period after sacrificed by CO2-inhalation in a chamber with increasing concentrations over time.
- No histological examinations were performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: Clinical observation - 2000 mg/kg test group: reduced feces was observed on study day 1 after administration - 300 mg/kg test group: impaired general state, dyspnoea, and piloerection Findings were observed from hour 2 through to hour 5 after administrat
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)