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EC number: 941-461-6 | CAS number: 1231930-42-9
- 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:
- 17 October 2013 to 31 October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 6-(2-chloro-5-fluoropyrimidin-4-yl)-4-fluoro-2-methyl-1-(propan-2-yl)-1H-1,3-benzodiazole
- EC Number:
- 941-461-6
- Cas Number:
- 1231930-42-9
- Molecular formula:
- C15H13CIF2N4
- IUPAC Name:
- 6-(2-chloro-5-fluoropyrimidin-4-yl)-4-fluoro-2-methyl-1-(propan-2-yl)-1H-1,3-benzodiazole
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch No.of test material: RS0-H71422-082- Storage condition of test material: Kept at room temperature under nitrogen
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Outside vendor- Age at study initiation: 8 weeks- Weight at study initiation: 214-271g (males) 180-197g (females)- Fasting period before study: Overnight prior to dosing- Housing: Polycarbonate cages containing appropriate bedding with an automatic watering valve- Diet (e.g. ad libitum): Standard certified commerical laboratory diet- Water (e.g. ad libitum): Municipal tap water- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 21-23- Humidity (%): 50-59- Air changes (per hr): minimum of 10- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- An appropriate quantity of test material was added to the requisite amount of de-ionised water and mixed manually until visibly homogeneous. Test material was administered orally as either a single dose (dose volume ≤20 mL/kg) or divided into two seperate doses (dose volume >20 mL/kg) administered with a 4-hour time span.Administered dose was calculated based on weight of the animal on the day of dosing.
- Doses:
- 300 mg/kg body weight2000 mg/kg body weight
- No. of animals per sex per dose:
- 300 mg/kg: 3 males and 3 females2000 mg/kg: 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: Frequency of observations and weighing: detailed clinical observations twice daily. Weighing prior to fasting (Day -1) prior to dosing (day 0), and on Days 7 and 14- Necropsy of survivors performed: No- Other examinations performed: clinical signs, body weight
- Statistics:
- Body weight means and standard deviations were calculated separately for males and females
Results and discussion
- Preliminary study:
- Not relevant, this is not a fixed dose study
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No morality occurred during the study
- Clinical signs:
- other: No abnormal clinical signs were present at 300 mg/kg and 2000 mg/kg
- Gross pathology:
- As no morality occurred during the study complete necropsy examinations were not undertaken
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, LSN2833975 is considered to be non-toxic. The Median Lethal Dose is estimated to be greater than 2000 mg/kg.
- Executive summary:
The single-dose oral toxicity of LSN2833975 was evaluated in Sprague Dawley rats. Two groups of rats (3 males and 3 females per group) were given a single oral dose of the test article at 300 mg/kg or 2000 mg/kg body weight. Following dosing, the rats were observed daily and weighed weekly. There were no test article-related clinical signs, effects on body weight, or gross necropsy findings observed at 300 mg/kg and 2000 mg/kg. Under the conditions of this test, LSN2833975 is considered to be non-toxic. The Median Lethal Dose is estimated to be greater than 2000 mg/kg.
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