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EC number: 814-072-3 | CAS number: 77614-79-0
- 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
- Study period:
- 26 Mar - 26 Apr 2019
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OQYEI National Institute of Pharmacy and Nutrition, Budapest, Hungary
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 3,5-bis(difluoromethyl)-1H-pyrazole
- EC Number:
- 814-072-3
- Cas Number:
- 77614-79-0
- Molecular formula:
- C5H4F4N2
- IUPAC Name:
- 3,5-bis(difluoromethyl)-1H-pyrazole
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Doses:
- 55, 175 and 550 mg/kg bw
Starting dose: 55 mg/kg bw
Dosing schedule: 55, 175, 55, 175, 550 and 175 mg/kg bw - No. of animals per sex per dose:
- 1 female per step (6 steps in total)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Individually after dosing at 30 minutes, then 1, 2, 3, 4, and 6 h and
once daily for 14 days thereafter or until death. Additional body weight measurements were made for the 4th animal (dosed 175 mg/kg bw) on Day 4, based on the clinical signs of the animal.
- Frequency of weighing: Before treatment, on Days 7 and 14 (at necropsy) and on the day of death.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 175 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 29.03 - 714
- Mortality:
- 55 mg/kg bw: 0/2 animals died
175 mg/kg bw: 2/3 animals died (Day 1 or 2)
550 mg/kg bw: 1/1 animals died (Day 1) - Clinical signs:
- other: 55 mg/kg bw: Slightly decreased activity, hunched back and piloerection in 2/2 animals, starting from the day of treatment up to Day 3 or 4, fully reversible within 5 days. 175 mg/kg bw: Decreased activity (slight, moderate or severe) in 3/3 animals, hunc
- Gross pathology:
- 55 mg/kg bw: Necropsy and histopathological examination revealed no substance-related findings.
175 mg/kg bw:
- animals found dead: Non-collapsed lung in 2/2 dead animals.
- animals sacrificed at termination: Necropsy and histopathological examination revealed no substance-related findings.
550 mg/kg bw:
- animals found dead: Diffuse red discoloration of all lobes of non-collapsed lungs and multifocal red discolouration of the glandular mucosa of the stomach in 1/1 dead animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute Oral 3, H301 according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Oral administration of the test substance according to OECD guideline 425 with the three dose levels 55, 175 and 550 mg/kg bw induced mortality at ≥ 175 mg/kg bw. Clinical signs of toxicity were observed in all animals and comprised decreased activity, hunched back and piloerection at ≥ 55 mg/kg bw and incoordination, reddish discharge from the nose and cold appearance at touch at ≥ 175 mg/kg bw. There was no impairment of body weight development. Gross necropsy of animals found dead revealed diffuse red discoloration of all lobes of non-collapsed lungs and multifocal red discolouration of the glandular mucosa of the stomach at 550 mg/kg bw and non-collapsed lungs at 175 mg/kg bw. Gross necropsy of surviving animals revealed no abnormalities. A LD50 value of 175 mg/kg bw was derived. The substance requires classification as Acute Oral 3, H301 according to CLP/EU GHS criteria.
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