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Diss Factsheets
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EC number: 815-961-9 | CAS number: 1374760-95-8
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 2 014
- Report date:
- 2014
Materials and methods
- Objective of study:
- other: stability
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The purpose of this study was to determine the relative stability of test item in human plasma as compared to other species in order to determine the suitability of the rat as a species for toxicology studies.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide
- EC Number:
- 815-961-9
- Cas Number:
- 1374760-95-8
- Molecular formula:
- C17H17N3O2S
- IUPAC Name:
- 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide
- Test material form:
- not specified
- Details on test material:
- No data
Constituent 1
- Specific details on test material used for the study:
- - Storage condition of test material: Stored at approximately 25 °C away from direct sunlight until the day of the experiment and/or analysis
- Radiolabelling:
- no
Results and discussion
Any other information on results incl. tables
The test item (750 ng/mL) was incubated with dog, human, minipig, monkey, rabbit, or rat plasma at 37°Cfor 24 hours. Peak area of the test item and S8551 (internal standard) as well as the ratio of peak area of test item/S8551, and normalized data in the various species are summarized in Table 1.
The test item was rapidly hydrolyzed in rat plasma with only 3.8% remaining at the 15 minute time point. In contrast, the test item was very stable in human, dog, and pig plasma with 90.0%, 110.4%, and 91.7%, respectively, remaining at the 24 hour time point. The test item was less stable in either monkey or rabbit plasma with 36.7% and 20.1%, respectively, remaining at the 24 hour time point. The results indicate that the plasma stability of the test item in humans is most similar to either dog or Gottingen pig.
Applicant's summary and conclusion
- Conclusions:
- The test item was rapidly hydrolyzed in rat plasma with only 3.8% remaining at the 15 minute time point. In contrast, the test item was very stable in human, dog, and pig plasma with 90.0%, 110.4%, and 91.7%, respectively, remaining at the 24 hour time point. The test item was less stable in either monkey or rabbit plasma with 36.7% and 20.1%, respectively, remaining at the 24 hour time point. The results indicate that the plasma stability of the test item in humans is most similar to either dog or Gottingen pig.
- Executive summary:
A study was conducted to determine the relative stability of the test item in human plasma as compared to other species in order to assess the suitability of the rat as a species for toxicology studies.
The test item (750 ng/mL) was incubated with human, rat, dog, rabbit, monkey, or Gottingen pig plasma at 37 °C for 24 hours. Duplicate aliquots (50 µL) were taken at 0, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0, and 24 hours and diluted into acetonitrile (150 µL) containing an internal standard (S8551). The samples were centrifuged to separate the precipitated proteins from the supernatant. The supernatant was analyzed by LC-MS/MS using an API 3200 QTrap equipped with an Agilent 1100 HPLC system in order to determine the percent of the test item remaining at the various time points. All data were normalized by ratio of peak area (test item/S8551) at the 0 hour time point.
The test item was rapidly hydrolyzed in rat plasma with only 3.8% remaining at the 15 minute time point. In contrast, the test item was very stable in human, dog, and pig plasma with 90.0%, 110.4%, and 91.7%, respectively, remaining at the 24 hour time point. The test item was less stable in either monkey or rabbit plasma with 36.7% and 20.1%, respectively, remaining at the 24 hour time point. The results indicate that the plasma stability of the test item in humans is most similar to either dog or Gottingen pig.
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