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EC number: 928-729-8 | CAS number: 188416-20-8
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 November 1997 to 18 May 1998
- 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:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-(6-chloro-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
- EC Number:
- 928-729-8
- Cas Number:
- 188416-20-8
- Molecular formula:
- C16H13ClF3N5O.HCl
- IUPAC Name:
- 3-(6-chloro-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
- Details on test material:
- - Analytical purity: 90%
- Lot/batch No.: 5ABJ002
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan U.K.Ltd., Bicester, Oxon, England
- Age at study initiation: eight to eleven weeks of age
- Weight at study initiation: 217 to 260 g
- Fasting period before study:
- Housing: Sub-Dividable Rodent Cage-Polished stainless steel 20cmhigh*39cmwide*39cmlong, no more than five animals of the same sex were accommodated in each cage.
- Diet : a standard laboratory rodent diet
- Water : ad libitum
- Acclimation period: a minimum period of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.5-21.5ºC
- Humidity (%): 42-60%
- Air changes (per hr):
- Photoperiod : 12 hours of artificial light (0700-1900hours) in 24-hour period
IN-LIFE DATES: From 1 to 15 July 1998
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: aqueous methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 50mm*50mm
- % coverage: 10% of the total body surface area
- Type of wrap if used: Covered with porous gauze held in place with a non irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water (30 to 40ºC )
- Time after start of exposure: at the end of 24 hours exposure period
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bodyweight
- Concentration (if solution): a maximum practical concentration of 40% w/v in 1% w/v aqueous methylcellulose
- Constant volume or concentration used: no
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 5ml/kg
- Concentration (if solution): 1% w/v aqueous methylcellulose
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg bodyweight
- No. of animals per sex per dose:
- a group of ten rats (five males and five females)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least twice daily for mortalities
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Clinical signs:
- other: A well-defined dermal response (erythema/oedema Grades 1 to 3) was first evident in all rats following removal of the dressing with a similar response also apparent 48 hours after dosing. These signs were accompanied by localised reactions characterised
- Gross pathology:
- No abnormalities were recorded at the macroscopic examination Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose to rats of this substance was demonstrated to be greater than 2000mg/kg bodyweight.
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