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EC number: 841-499-2 | CAS number: 1340593-59-0
- 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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
Embryo-Fetal Developmental Toxicity in Rats
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-(2,4-difluorophenyl)-1,1-difluoro-3-(1H-1,2,3,4-tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl}propan-2-ol
- EC Number:
- 841-499-2
- Cas Number:
- 1340593-59-0
- Molecular formula:
- C23H16F7N5O2
- IUPAC Name:
- 2-(2,4-difluorophenyl)-1,1-difluoro-3-(1H-1,2,3,4-tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl}propan-2-ol
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- VEHICLE
- Concentration of vehicle : 0.5% - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- not specified
- Duration of treatment / exposure:
- Gestation Day (GD) 6 through 17
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 3 mg/kg bw/day (nominal)
- Remarks:
- Low dose
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Remarks:
- Mid dose
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Remarks:
- High dose
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Other: Blood for TK assessments was collected from satellite groups of 3-5 animals on GD 6 and 17
Examinations
- Maternal examinations:
- Not specified
- Ovaries and uterine content:
- Not specified
- Fetal examinations:
- Not specified
- Statistics:
- Not specified
- Indices:
- Not specified
- Historical control data:
- Not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- For further details see section "details on results" below.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- For further details see section "details on results" below.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Maternal toxicity was evident at 40 mg/kg bw/day and consisted of significantly lower gestation body weights, lower body weight gain, and reduced food consumption.
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- For further details see section "details on maternal toxicity effects" below.
- Details on maternal toxic effects:
- Maternal toxicity was evident at 40 mg/kg bw/day and consisted of significantly lower gestation body weights.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Remarks:
- maternal toxicity
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse signs of toxicity observed
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Mean fetal body weights (males, females, and combined) and fetal external, visceral, and skeletal malformations or variations were unaffected at any of the dose levels evaluated.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No developmental toxicity observed at the highest dose evaluated
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In an embryo-fetal developmental toxicity study, the test item in 0.5% CMC was administered to 25 time-mated female SD rats per dose orally at dose levels of 0,3, 10 and 40 mg/kg bw/day from day 6 through 17 of gestation. Maternal toxicity was evident at 40 mg/kg bw/day and consisted of significantly lower gestation body weights, lower body weight gain, and reduced food consumption. Thus, NOAEL for maternal toxicity is 10 mg/kg bw/day. There were no treatment-related effects in developmental parameters. Thus, the NOAEL for developmental toxicity is 40 mg/kg bw/day.
- Executive summary:
In an embryo-fetal developmental toxicity study, the test item in 0.5% CMC was administered to 25 time-mated female SD rats per dose orally at dose levels of 0,3, 10 and 40 mg/kg bw/day from day 6 through 17 of gestation. Maternal toxicity was evident at 40 mg/kg bw/day and consisted of significantly lower gestation body weights, lower body weight gain, and reduced food consumption. Thus, NOAEL for maternal toxicity is 10 mg/kg bw/day. There were no treatment-related effects in developmental parameters. Thus, the NOAEL for developmental toxicity is 40 mg/kg bw/day.
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