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EC number: 635-156-4 | CAS number: 109293-98-3
- 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:
- 1995-05-10 until 1995-06-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically valid study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- November 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- EC Number:
- 635-156-4
- Cas Number:
- 109293-98-3
- Molecular formula:
- C15 H12 F2 N4 O3 .Na
- IUPAC Name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd, Bicester, Oxon, England
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: 192 - 260 g
- Housing: metal cages with wire mesh floors
- Diet: a standard laboratory rodent diet (SDS LAD 1), ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30 - 70 %
- Air changes: 10 - 15 air changes per hour
- Photoperiod: 12 hours of artificial light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % w/v aqueous methylcellulose
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg- Doses:
- 5000, 3200, 1600 mg/kg bw
- No. of animals per sex per dose:
- 10 rats per dose: 5 males, 5 females
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily - clinical signs - daily and weighing 3 times during the observation period (once a week)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights - Statistics:
- The acute median lethal oral dose (LD50) to male and female rats was calculated using the method of Finney [FINNEY, D.J. (1971) Probit Analysis, 3rd Cambridge University Press, Cambridge].
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 800 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two females at 3200 mg/kg bw and 3 males and all females at 5000 mg/kg died during the study. Deaths occurred between 24 to 48 hours of dosing.
- Clinical signs:
- Clinical signs of reaction to treatment included piloerection and soft to liquid faeces, seen among rats at all three dosages. In addition, abnormal body carriage, abnormal gait, lethargy, decreased respiratory rate, partially closed eyelids, pallor of the extremities, increased urine production, increased salivation, gasping, walking on toes, unsteadiness, increased lacrimation, bluish colour to skin/extremities, cold body surfaces, prostration, brown staining around nose and mouth and red stained urine were seen among rats at one or more dose levels. Recovery of surviving rats was complete in all instances by day 7.
- Body weight:
- Slight bodyweight losses were recorded for all decedents. A slightly low bodyweight gain was recorded on day 8 for one male at 5000 mg/kg and two females at both 1600 and 3200 mg/kg. A similar trend was noted on day 15 for two males and one female at 1600 m g/kg, with one further female at 1600 mg/kg showing a slight bodyweight loss at this time. All other surviving animals achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- Macroscopic examination revealed changes to all major organs and tissues of animals who died during the observation period. No abnormalities were recorded at the macroscopic examination on day 15.
Applicant's summary and conclusion
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