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EC number: 242-440-8 | CAS number: 18599-22-9
- 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:
- 17 March 2020 - 09 April 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-bromo-3,3,4,4-tetrafluorobut-1-ene
- EC Number:
- 242-440-8
- EC Name:
- 4-bromo-3,3,4,4-tetrafluorobut-1-ene
- Cas Number:
- 18599-22-9
- Molecular formula:
- C4H3BrF4
- IUPAC Name:
- 4-bromo-3,3,4,4-tetrafluorobut-1-ene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Raleigh, Raleigh, NC
- Age at study initiation: 8 weeks old
- Weight at study initiation: 244 to 302 g
- Fasting period before study: Animals were fasted the day before dosing.
- Housing: Group housing (up to 3 animals per cage) in polycarbonate cages, containing appropriate bedding material and an automatic watering valve. Animals were socially housed for psychological/environmental enrichment and were provided with items such as a chewing object. Edible enrichment treats were also offered throughout the study.
- Diet: Ad libitum (except during designated procedures), Pelleted Lab Diet Certified CR Rodent Diet 5CR4. (Based on analysis provided by the supplier it is considered that there were no known contaminants in the feed that interfered with the objectives of the study)
- Water: Ad libitum (except during designated procedures), Municipal tap water, treated by reverse osmosis and ultraviolet irradiation (Based on periodic analysis of the water it is considered that there were no known contaminants in the water that interfered with the outcome of the study.)
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 (targeted conditions)
- Humidity (%): 30-70 (targeted conditions)
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23 March 2020 - 09 April 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
No vehicle was used, the substance was administered as received.
DOSE VOLUME APPLIED:
2000 mg/kg bodyweight
The dose volume (1.29 mL/kg) did not exceed 20 mL/kg for aqueous preparations.
CLASS METHOD
Rationale for the selection of the starting dose: Because the test substance was thought to be of low toxicity, a limit test was conducted at a single high-dose level (e.g., 2000 mg/kg). - Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 2 groups of 3 males/dose
- Control animals:
- no
- Details on study design:
- The test substance was administered using a syringe attached to a gavage cannula. Individual doses were calculated based on the animal’s fasted (Day 0) body weight. The dose formulations were inverted 5 times prior to dosing. Animals were returned to ad libitum feeding after dosing.
Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- Mortality/Viability: twice daily;
- Body weights: on the day of dosing (fasted weight) and on day 0 (pre-administration), 7 and 14;
- Clinical signs: at periodic intervals on the day of dosing (day 0) and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- The LD50 cut-off value was established based on OECD guideline 423. No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- There were no test substance-related clinical observations.
- Body weight:
- There were no test substance-related effects on body weight. All dosed animals gained weight from Day 0 to Day 14.
- Gross pathology:
- There were no test substance-related macroscopic pathology findings. Dark discoloration of the thymus (left lobe) in one animal was observed.This macroscopic pathology finding is a common incidental finding in toxicity studies for this age and strain of rat.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on an acute toxicity study performed according to OECD TG 423 and in accordance with GLP principles the acute oral LD50 of BTFB was determined to be > 2000 mg/kg in the male rat.
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