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EC number: 917-473-2 | CAS number: 188416-34-4
- 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:
- other: Study run to a method comparable with current guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- 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:
- 2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-yl [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonate
- EC Number:
- 917-473-2
- Cas Number:
- 188416-34-4
- Molecular formula:
- C16H14F3N5O . C10H16O4S
- IUPAC Name:
- 2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-yl [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonate
- Reference substance name:
- (2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
- IUPAC Name:
- (2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
- Details on test material:
- - Batch No.: 5ABK-003
- Purity: 96.5%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Doses:
- A group of ten fasted rats(five males and five femals) was given a single dose by oral gavage of the test substance, formulated in 1% w/v aqueous methylcellulose and administered at an initial dose level of 500 mg/kg bodyweight. A further group of five males and five females rats was dosed at 50 mg/kg bodyweight to determine the discriminating dosage of the test material.
- No. of animals per sex per dose:
- Preliminary sighting study: 2 (female)
Main study: 5 (male)
Main study: 5 (female) - Control animals:
- no
- Details on study design:
- A group of ten fasted rats(five males and five femals) was given a single dose by oral gavage of the test substance, formulated in 1% w/v aqueous methylcellulose and administered at an initial dose level of 500 mg/kg bodyweight. This dose level was chosen on the basis of preliminary study results and in compliance with the study guideling. A further group of five males and five females rats was dosed at 50 mg/kg bodyweight to determine the discriminating dosage of the test material.
Results and discussion
- Preliminary study:
- Species/strain: Rat (Sprague-Dawley)
2000 mg/kg bw: Evident toxicity: Y; Mortality: Y
500 mg/kg bw: Evident toxicity: Y; Mortality: N
Observations:
These results were used to set the starting dose for the main study.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 50 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 500 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Three males and all females at 500 mg/kg died during the study. All deaths occurred within 4 days of dosing.
Female 500 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 5; No. of animals used: 5
Male 500 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 3; No. of animals used: 5
Female 50 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5
Male 50 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5 - Clinical signs:
- other: Signs of toxicity: Clinical signs of reaction to treatment included piloerection and hunched posture, seen in all rats at both dosages. In addition, waddling gait, lethargy, decreased respiration, partially closed eyelids, pallor of the extremities, calo
- Gross pathology:
- Effects on organs:
Macroscopic examination of surviving rats killed on Day 15 revealed no abnormalities. - Other findings:
- Three males and all females at 500 mg/kg died during the study. All deaths occurred within four days of dosing.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 is between 50 and 500 mg/kg bw/day.
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