Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Version / remarks:
- May 1981
- GLP compliance:
- yes (incl. QA statement)
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
- Remarks:
- Crl:CD-1(ICR)BR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- other: 100 mM Sodium hydrogen carbonate/ L demineralized water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The formulations were prepared once weekly taking into account the analytically determined stability. For the preparation of the formulations the content of test item was calculated based on the purity of 100 %. Preparation of the test formulations was performed based on weight, not taking into account the actual density of the vehicle.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Prior to the start of treatment, the test formulation was checked with regard to accuracy of concentration and stability of dosage forms prepared in the same way as it was done in the study. Analyses were carried out before the start of the study. Stability: Prior to the start of treatment the dosage forms were analyzed shortly after preparation, 4, 8, and 14 days thereafter. After termination of the study the dosage forms were analyzed shortly after preparation, 7, and 14 days thereafter.
- Duration of treatment / exposure:
- At all dose levels, 60 animals per dose and sex were used as main groups treated over a period
of 728-736 days. - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mg/kg via drinking water
- Dose / conc.:
- 0.54 other: mg/kg via drinking water
- Dose / conc.:
- 1.61 other: mg/kg via drinking water
- Dose / conc.:
- 5.35 other: mg/kg via drinking water
- No. of animals per sex per dose:
- 60
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In conclusion, in a 2-year oncogenicity study in mice, Molidustat is non-carcinogenic.
Minor mode of action-related effects on hematopoiesis were observed at 5 mg/kg. - Executive summary:
In a study conducted according to OECD guideline 451 (1981) the carcinogenic potetial of Molidustat was investigated by daily oral administration in drinking water of 0, 0.54, 1.61, and 5.35 mg/kg of the substance over a period of up to 2 years to female and male CD-1 mice. The treatment of mice with the test item was well tolerated.
No test item-related mortality or toxicologically relevant test-item-related signs of systemic toxicity were observed up to the high dose of 5 mg/kg. Histopathological investigation did not show any treatment-related increase in neoplastic and non-neoplastic lesions up to and including 5 mg/kg. Thus, Molidustat, is non-carcinogenic in mice. Based on the pharmacological mode of action of the test item, erythrocyte count, hemoglobin concentration and hematocrit value were significantly increased in both sexed dosed at 5.0 mg/kg which was also reflected in a slight increase in medullary and splenic erythropoiesis. In conclusion, in a 2-year oncogenicity study in mice, Molidustat is non-carcinogenic. Minor mode of action-related effects on hematopoiesis were observed at 5 mg/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.