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EC number: 875-892-5 | CAS number: 1375799-59-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- Subacute oral toxicity study in CD-1 mice (2 weeks)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
- Principles of method if other than guideline:
- In a subacute toxicity study 15 male and 15 female mice per dose group were treated with 15 or 150 ppm of the test item in their drinking water for two weeks. 5 males and 5 females each served as control groups. The animals were observed for clinical signs and body weights, food and water consumption was measured. Blood for toxicokinetic investigation was collected at the end of the study.
The treatment resulted in the following mean daily test substance intake (in ascending dosages): 3.3 and 34.7 mg test item/kg body weight in males and 4.2 and 41.1 mg test item /kg body weight in females. - GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-5-olate
- EC Number:
- 875-892-5
- Cas Number:
- 1375799-59-9
- Molecular formula:
- C13 H14 N8 O2 . Na
- IUPAC Name:
- Sodium 1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-5-olate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Details on route of administration:
- 2 weeks (Animals received the test substance/tap water mixture until day of scheduled necropsy).
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The micronized test substance was administered in the tap water. The test substance was mixed into the drinking water at the appropriate concentrations at room temperature. The formulations were prepared once per week.
- Analytical verification of doses or concentrations:
- yes
- Remarks:
- The suitability of the proposed formulations was confirmed by the analyses of concentration and stability of dosage forms with concentrations of 0.001 mg/mLand 0.4 mg/mL. Analyses were carried out before the start of the study.
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 150 ppm
- Dose / conc.:
- 15 ppm
- Dose / conc.:
- 0 ppm
- No. of animals per sex per dose:
- 5 in the negative control and 15 in the treatment groups
- Control animals:
- yes, concurrent no treatment
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- Dose descriptor:
- NOAEL
- Effect level:
- 150 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- water consumption and compound intake
Applicant's summary and conclusion
- Conclusions:
- In a subacute toxicity study 15 male and 15 female mice per dose group were treated with 15 or 150 ppm Molidustat in their drinking water for two weeks. 5 males and 5 females each served as control groups. Survival was not affected by the treatment. With the exception of reddened skin, no further treatment-related clinical findings were recorded. At 150 ppm the body weight development in females was slightly retarded. Food intake was not affected by the treatment. Water intake was in treated females groups and in 150 ppm males was slightly increased. The no-observed-adverse-effect level was 150 ppm in males and 15 ppm in female (due to a slight effect on body weight development).
- Executive summary:
In a subacute toxicity study 15 male and 15 female mice per dose group were treated with 15 or 150 ppm of the test item in their drinking water for two weeks. 5 males and 5 females each served as control groups.
The animals were observed for clinical signs and body weights, food and water consumption was measured. The treatment resulted in the following mean daily test substance intake (in ascending dosages): 3.3 and 34.7 mg test item/kg body weight in males and 4.2 and 41.1 mg/kg body weight in females. Survival was not affected by the treatment. With the exception of reddened skin, no further treatment-related clinical findings were recorded.
In all male dose groups and in females at 15 ppm body weight development was comparable to that in the respective control group. At 150 ppm the body weight development in females was slightly retarded.
Food intake was not affected by the treatment. Water intake was in treated females groups and in 150 ppm males was slightly increased. The no-observed-adverse-effect level was 150 ppm in males and 15 ppm in female (due to a slight effect on body weight development).
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