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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 February - 14 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute 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: N/A
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item formulated using proylene glycol within 4 h of dosing.
- 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 the formulation was 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. 8-9 weeks old
- Weight at study initiation: ± 20 % of the sex mean
- Fasting period before study: No
- Housing: Individually housed in polycarbonate cages (Type III, height 15 cm) containing purifed sawdust as bedding (SAWI, Jelu Werk, Rosenburgh, Germany).
- Diet (e.g. ad libitum): Standard pelleted laboratory animal feed (from Altorim (code VRF 1)) provided ad libitum.
- Water (e.g. ad libitum): Tap water provided ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 ºC
- Humidity (%): 30 - 70 % relative humidity (RH)
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12:12 light:dark
IN-LIFE DATES: From: To: Not reported
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10
- Type of wrap if used: Surgical gauze (Surgy 1D) covered with aluminium foil and Coban flexible bandage. Dressings on females were further fixed with Micropore tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes- water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bodyweight
- Concentration (if solution): Not reported
- Constant volume or concentration used: Not reported
- For solids, paste formed: N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical signs were made twice daily. Body weights were recorded on Day 1 (pre-exposure), Day 8 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight. - Statistics:
- Not performed
Results and discussion
- Preliminary study:
- Not conducted
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- lethargy (hypoactivity)
- Body weight:
- lower than 10% body weight loss
- Remarks:
- Slightly body weigh loss was noted in 2 females between day 1 and 8.
- Gross pathology:
- No abnormalities were noted.
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 /5 |
0 / 5 |
0 / 10 |
N/A |
5 / 5 |
5 / 5 |
10 / 10 |
N/A not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of the test item in Wistar rats exceeded 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (OECD 402) groups of young adult Wistar rats (male and female) were dermally exposed to test item in ethylene glycol for 24 hours to 10 % of the total skin area at a single dose 2000 mg/kg bw. Animals then were observed for 14 days.
No mortality was observed in the limit test.
Clinical signs of toxicity were observed in all individuals including lethargy, tremor, hunched posture, chromodacryorrhoea, ptosis, quick breathing and/or piloerection were noted among the animals between Day 1 - 9. In one female hunched posture was noted until Day 13. In a second female chromodacryorrhoea was noted between Day 9 - 12. In another female chromodacryorrhoea was noted from Day 9 on wards. General erythema, scales, scabs and/or swelling were seen in the treated skin-area of the animals during the observation period. Reduced body weight gain was observed in the males between Day 1 - 8 and among females through the whole study period. Slight body weight loss was observed in some females between Day 1 – 8. No macroscopic abnormalities were observed in the post mortem examination.
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