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EC number: 428-100-3 | CAS number: 94239-04-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 428-100-3
- EC Name:
- -
- Cas Number:
- 94239-04-0
- Molecular formula:
- C6H3NF4
- IUPAC Name:
- 2-fluoro-6-(trifluoromethyl)pyridine
- Details on test material:
- - Purity: 99.7%
Constituent 1
- Specific details on test material used for the study:
- Substance ID: F6TF
Lot #: 8922/16
Purity: 99.7%
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Males weighed 291-430 g and the females weighed 238-248 g
- Fasting period before study: Fasted overnight immediately prior to dosing
- Housing: A maximum of 5 rats was housed per cage, sexes separately
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70%
- Air changes (per hr): A minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): Artificial, giving 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DOSAGE PREPARATION: Dose levels were altered by adjusting the concentration of the dosing preparations. The volume of the dose was calculated for each animal according to its weight at the time of dosing. A standard volume of l0 mL/kg of the dosing preparation was administered by oral gavage using a stomach tube.
- Doses:
- Sighting phase: 500 and 2000 mg/kg
Main Study: 50 and 500 mg/kg - No. of animals per sex per dose:
- Sighting phase: 1 female per dose
Main study: 5 per sex at 500 mg/kg; 5 males at 50 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: Main study up to day 15; Sighting phase up to day 7
- Frequency of observations and weighing: The animals were observed for signs of systemic toxicity twice following dosing on day 1. Subsequent observations were made daily. The animals were weighed prior to fasting on the day before dosing (day -1), immediately before dosing (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- discriminating dose
- Effect level:
- 50 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Sighting Phase: Following a dose of 500 mg/kg, the animal survived and showed signs of slight, but evident, toxicity. Following a dose of 2000 mg/kg, the animal was killed in extremis on day 2. At examination post mortem this animal had a dark liver.
Main Study: Following a dose of 500 mg/kg to male and female rats, three males were killed in extremis on day 2. Surviving animals showed signs of evident toxicity, with complete recovery by day 5. No animals died following a dose of 50 mg/kg. - Clinical signs:
- other: There were signs of evident toxicity in the surviving animals, with complete recovery by day 5.
- Body weight:
- other body weight observations
- Remarks:
- With the exception of one female, which showed a slight weight loss, all surviving animals showed an overall bodyweight gain during the study.
- Gross pathology:
- Distension of the stomach was seen in the three males dosed with 500 mg/kg which were killed in extremis. This finding is considered to be treatment-related. In the males dosed with 50 mg/kg, one animal had only one testis (congenitally absent) and two males had speckling of the thymus. These are spontaneous or non-specific findings and are considered to be unrelated to treatment.
Applicant's summary and conclusion
- Conclusions:
- The highest fixed dose of the test substance administered in this test without causing any lethality (i.e., the overall discriminating dose-level) was 50 mg/kg.
- Executive summary:
A group of 5 male and 5 female rats was dosed with 500 mg/kg of the test substance and assessed daily for 14 days for any signs of systemic toxicity. A further group of 5 male rats was similarly treated, but dosed with 50 mg/kg. Bodyweights were recorded at intervals throughout the study. Animals in extremis and those surviving to the end of the study were killed and subjected to a macroscopic examination post mortem.
Following a dose of 500 mg/kg to 5 male and 5 female rats, 3 males were killed in extremis on day 2. Surviving animals showed signs of evident toxicity, with complete recovery by day 5. Distension of the stomach was seen in the 3 males killed in extremis. This finding is considered to be treatment-related. No mortality was observed following a dose of 50 mg/kg to 5 male rats, and there were no signs of toxicity. The highest fixed dose of the test substance administered in this test without causing any lethality (i.e., the overall discriminating dose-level) was 50 mg/kg.
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