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EC number: 216-036-7 | CAS number: 1478-61-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 February - 02 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with International guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Cas Number:
- 1478-61-1
- Molecular formula:
- C15H10F6O2
- IUPAC Name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
- Stability under test conditions: Not reported
- Solubility and stability of the test substance in the solvent/vehicle: Not reported
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not reported
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item formulated in propylene glycol within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: Not reported
- Final preparation of a solid: N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material): Liquid
OTHER SPECIFICS: Homogeneity of formulation confirmed by visual inspection.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: ca. 9 weeks
- Weight at study initiation: Did not exceed ± 20 % of the sex mean
- Fasting period before study: Yes - 20 h prior to dosing (max.) and for 3-4 h after dosing.
- Housing: 3 animals housed per Macrolon cage (Type IV, height 15 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenburg, Germany).
- Diet (e.g. ad libitum): Standard pelleted laboratory animal diet (from Altromin (Code VRF 1)) provided ad libitum.
- Water (e.g. ad libitum): Tap water provided ad-libitum.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): ca. 15.
- Photoperiod (hrs dark / hrs light): 12:12 light:dark
IN-LIFE DATES: From: To: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Guideline recommended
- Lot/batch no. (if required): Not reported
- Purity: Not reported
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): Test item formulated in propylne glycol within 4 hours prior to dosing. Homogeneity of formulation confirmed by visual inspection.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not reported - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality were made twice daily. Bdy weights were recorded on Day 1 (pre-dose) and Day 8 and 15. Clinical signs were recorded once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights and necropsy. - Statistics:
- Not performed
Results and discussion
- Preliminary study:
- N/A
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- lethargy (hypoactivity)
- Body weight:
- lower than 10% body weight loss
- Remarks:
- Slight body weight loss in individuals animals was noted between day 1 and 8 (1 male -12% and 1 female -8%).
- Gross pathology:
- No abnormalities were observed.
Any other information on results incl. tables
Table 2: Number of animals dead (and with evident toxicity) (and time range within which mortality occured)
Nominal dose (mg/kg bw) |
Mortality (No. dead / total) |
Time range of deaths (hours) |
Clinical signs (No. / total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
0 /3 |
0 / 3 |
0 / 6 |
N/A |
3 / 3 |
2 / 3 |
5 / 6 |
N/A not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of the test item in Wistar rats exceeded 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (OECD 423) groups of fasted, 9 week old, Wistar rats (3 male, 3 female) were given a single oral dose of test item in propylene glycol at a single dose of 2000 mg/kg bw and observed for 14 days.
No mortality was observed in the limit test.
Clinical signs of toxicity were observed in 2 /3 females, namely hunched posture between Days 1 - 3 and 7 - 9. Clinical signs of toxicity were also observed in all of the males rats including lethargy, hunched posture, chromodacryorrhoea, rales and/or piloerection between Days 1 - 7. Salivation was also observed in all male rats however this is commonly seen after treatment by oral gavage and was therefore not considered to be of toxicologial relevance. No macroscopic abnormalities were observed in the post mortem examination.
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