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Diss Factsheets
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EC number: 469-910-7 | CAS number: 847842-48-2
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 9 January 1997 and 2 May 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Type of study / information:
- 1592U89 is a nucleoside analog that is an HIV reverse transcriptase inhibitor. This study describes a bioequivalence study of 1592U89 succinate and
hemisulfate salt forms in male cynomologous monkeys after single oral doses of 30mg(base)/kg.
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Abacavir Hemisulphate
- IUPAC Name:
- Abacavir Hemisulphate
- Reference substance name:
- 188062-50-2
- Cas Number:
- 188062-50-2
- IUPAC Name:
- 188062-50-2
- Reference substance name:
- Abacavir Succinate
- IUPAC Name:
- Abacavir Succinate
- Reference substance name:
- 168146-84-7
- Cas Number:
- 168146-84-7
- IUPAC Name:
- 168146-84-7
- Details on test material:
- - Name of test material (as cited in study report): 1592U89 Hemisulfate
- Molecular formula (if other than submission substance): Please see attachment 1.
- Molecular weight (if other than submission substance): Please see attachment 1.
- Structural formula attached as image file (if other than submission substance): Please see attachment 1.
- Name of test material (as cited in study report): 1592U89 Succinate
- Molecular formula (if other than submission substance): Please see attachment 2.
- Molecular weight (if other than submission substance): Please see attachment 2.
- Structural formula attached as image file (if other than submission substance): Please see attachment 2.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Results and discussion
Any other information on results incl. tables
Review of the records from the in vivo portion of the study revealed that the 1592U89 Hemisulfate was administered as a single 22 mg(base)/kg dose, rather than the 30 mg(base)/kg dose administered during the 1592U89 Succinate phase of the study.
There was no statistical difference between plasma exposure to 1592U89 in male cynomolgus monkeys from the Succinate and Hemisulfate salts forms, as measured by dose-normalized AUC(0-oo) and Cmax. Furthermore, there was no statistical difference between terminal t1/2, MRT, or Tmax for the two salt forms. Parameter estimates and variability (standard deviation) around the estimates were within expected ranges, based on historical pharmacokinetic data in cynomolgus monkeys.
Applicant's summary and conclusion
- Conclusions:
- There was no statistical difference between the succinate and hemisulfate salt forms in plasma exposure to 1592U89 in male cynomolgus monkeys, as measured by dose-normalized AUC(0 -oo) and Cmax. Furthermore, there was no statistical difference between terminal t1/2, MRT, or Tmax for the two salt forms. Parameter estimates and variability (standard deviation) around the estimates were within expected ranges, based on historical pharmacokinetic data in cynomolgus monkeys.
- Executive summary:
Plasma concentrations of 1592U89 were determined in four male cynomolgus monkeys following single oral doses, nominally of 30mg(base)/kg of 1592U89 Succinate or 1592U89 Hemisulfate, in a randomized crossover study design.
Review of the records from the in vivo portion of the study revealed that the 1592U89 Hemisulfate was administered as a single 22mg(base)/kg dose, rather than the 30mg(base)/kg dose administered during the 1592U89 Succinate phase of the study. Therefore, exposures were compared using dose-normalized data.
There was no statistical difference between the succinate and hemisulfate salt forms in plasma exposure to 1592U89 in male cynomolgus monkeys, as measured by dose-normalized AUC(0 -oo) and Cmax. Furthermore, there was no statistical difference between terminal t1/2, MRT, or Tmax for the two salt forms. Parameter estimates and variability (standard deviation) around the estimates were within expected ranges, based on historical pharmacokinetic data in cynomolgus monkeys.
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