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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- 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: 99.56%
Constituent 1
- Specific details on test material used for the study:
- Substance ID: F6TF
Purity: 99.56%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: approximately 200-250 g
- Fasting period before study: No
- Housing: Plastic cages and numbered individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25°C
- Humidity (%): 40-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Prescribed amounts of the test substance were mixed with distilled water according to the prescribed doses at the time of administration.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Not reported
- Duration of treatment / exposure:
- Days 6 to 15 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- No. of animals per sex per dose:
- A minimum of 15 pregnant rats/dose were examined
- Control animals:
- yes, concurrent vehicle
- other: A positive control group was included, but the positive control material was not reported.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Every 3 days, including the day of dissection
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20 - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- T-test method was used for body weight growth of pregnant rats, body length, tail length, and body weights of foetuses. Χ2-test method was used for absorptivity, mortality, and teratogenic rate of foetuses.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Three rats in 100 mg/kg dose group and six rats in 200 mg/kg dose group died during the test period.
- Body weight and weight changes:
- no effects observed
Maternal developmental toxicity
- Pre- and post-implantation loss:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Three rats died at 100 mg/kg and 6 rats died at 200 mg/kg during the test period.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Fetal body weight changes:
- effects observed, non-treatment-related
- Changes in sex ratio:
- no effects observed
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Delayed sternebral ossification was observed at 200 mg/kg.
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
A slight increase in resorptions was observed at 200 mg/kg, without adverse effects on mean litter size. Reduced mean tail length and fetal weight were observed at 100 and 200 mg/kg. Delayed sternebral ossification was observed at 200 mg/kg.
Effect levels (fetuses)
- Key result
- Basis for effect level:
- other:
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test substance has toxic effects on parents and may cause delay of fetus growth at doses above 100 mg/kg but no teratogenic effects.
- Executive summary:
Sprague Dawley (SD) rats were used as test animals. Three dose groups (50, 100, and 200 mg/kg body weight/day) were set based on the results of the preliminary test. A negative control and a positive control were used synchronously. Pregnant rats were administered daily by oral gavage on the 6th to 15th day of gestation and were sacrificed at the 20th day of gestation. At necropsy, the uteri were removed and weighed. The number of corpora lutea, live foetuses, early dead foetuses, late dead foetuses, and resorptions were recorded. The sex, body weight, body length, tail length of each live foetus and the weight of the placenta were recorded as well. External, skeletal, and visceral examinations were conducted. All data were processed.
The test substance has toxic effects on parents and delayed foetal growth at 100 and 200 mg/kg by oral administration. At 200 mg/kg, it also delayed the skeletal growth of the foetus. No teratogenic effects were found at 50, 100, or 200 mg/kg. Based on the findings of the study, the test substance would be considered to be a toxicant at dose levels greater than or equal to 100 mg/kg, based on decreased total number of pregnant rats, delayed foetus growth, and delayed skeletal growth. No teratogenic effects were observed at 200 mg/kg (the highest dose tested).
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