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Diss Factsheets
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EC number: 200-718-6 | CAS number: 69-89-6
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- other: hospital admission data
- Adequacy of study:
- supporting study
- Reliability:
- other: Not applicable
- Rationale for reliability incl. deficiencies:
- other: Not applicable - hospital admission data
Data source
Reference
- Reference Type:
- publication (copyright not owned for reproduction)
- Title:
- Hospital Admission for Xanthine Toxicity
- Author:
- Derby LE, Jick SS, Langlois JC, Johnson LE, and Jick H
- Year:
- 1 990
- Bibliographic source:
- Pharmacotherapy, 10(2):112-114
Materials and methods
- Type of study / information:
- Hospitalization admission data
- Endpoint addressed:
- other: toxicity
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The incidence rate of hospitalization due to test substance toxicity was reported.
- GLP compliance:
- no
Test material
- Reference substance name:
- Purine-2(3H),6(1H)-dione
- EC Number:
- 200-718-6
- EC Name:
- Purine-2(3H),6(1H)-dione
- Cas Number:
- 69-89-6
- Molecular formula:
- C5H4N4O2
- IUPAC Name:
- xanthine
Constituent 1
- Specific details on test material used for the study:
- Purity: not reported
Results and discussion
- Results:
- A follow-up study of 35,909 outpatients who filled more than 220,000 prescriptions for theophylline over 9 years revealed 30 hospitalizations for xanthine toxicity. The overall estimated incidence rate of 7.8/10,000 person-years at risk indicates that in this population, hospitalization for xanthine toxicity is a relatively rare event.
Applicant's summary and conclusion
- Executive summary:
Theophylline and other xanthine derivatives have a long history of use for both acute bronchodilation and prophylaxis for pulmonary disorders. While these preparations have been demonstrated to have beneficial effects at therapeutic blood levels, toxicity can occur at levels just above the therapeutic range. The manifestations of theophylline toxicity vary from relatively minor complaints, such as nausea and vomiting, to more serious problems, such as arrhythmias and seizures. Although numerous case reports have described theophylline toxicity, the overall risk of hospitalization for this problem is not known. The authors examined the frequency of hospitalization for toxicity attributable to outpatient use of theophylline at GHC, a health maintenance organization (HMO) in Seattle, Washington, from 1978 to 1987. In the GHC population, 35,909 people filled a total of 223,137 prescriptions for theophylline over the 9 years of study. There were only 30 admissions for theophylline toxicity. Thus, the overall risk for hospitalization for toxicity was estimated to be about 7.8/10,000 person-years at risk, making it a relatively rare event. The low frequency of hospitalization combined with the fact that no deaths were recorded over 9 years suggests that at GHC, theophylline, a xanthine derivative, is a relatively low-risk drug for serious toxicity.
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