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EC number: 208-970-9 | CAS number: 549-56-4
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is not done according to OECD guideline, but it is a well documented study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of oral activated charcoal on quinine elimination.
- Author:
- Lockey, D. and Bateman, D. N.
- Year:
- 1 989
- Bibliographic source:
- Br. J. clin. Pharmac.27:92-94
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The protocol was approved by the local Ethics Committee and seven healthy male volunteers (mean age 21 years) agreed to participate in the experiment. On each of 2 days, separated by more than 1 week, the volunteers attended the clinical laboratory after an overnight fast. At 09:00 h a 600 mg dose of quinine bisulphate was given as tablets with 100 ml water. Blood samples were obtained before dosing with quinine, and subsequently at 3 h intervals for 15 h and at 24, 30 and 36 h. On one of the investigation days no additional treatment was given and subjects were allowed free access to food from 2 h after the dose of quinine. Plasma samples were separated by centrifugation and quinine was measured by a fluorimetric technique (Cramer & Isaksson, 1963) following organic extraction. Samples from each subject were analysed in the same batch, within assay coefficient or variation being less than 5% at 1 mg/L. The lower limit of detection was 0.05 mg/L.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Quinine hydrogen sulphate
- EC Number:
- 208-970-9
- EC Name:
- Quinine hydrogen sulphate
- Cas Number:
- 549-56-4
- Molecular formula:
- C20H24N2O2.H2O4S
- IUPAC Name:
- (R)-[(2S,4S,5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl](6-methoxyquinolin-4-yl)methanol; sulfuric acid
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Quinine bisulphate
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- 600 mg dose of quinine bisulphate was given as tablets with 100 ml water.
Doses / concentrations
- Remarks:
- Doses / Concentrations:600 mg dose of quinine bisulphate
- No. of animals per sex per dose / concentration:
- seven healthy male volunteers (mean age 21 years)
- Control animals:
- not specified
- Details on dosing and sampling:
- At 09.00 h a 600 mg dose of quinine bisulphate was given as tablets with 100 ml water. Blood samples were obtained before dosing with quinine bisulphate, and subsequently at 3 h intervals for 15 h and at 24, 30 and 36 h. Plasma samples were separated by centrifugation and quinine was measured by a fluorimetric technique (Cramer & Isaksson, 1963) following organic extraction.
Results and discussion
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: 53.9 mg/L* h
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 8.23 h
Metabolite characterisation studies
- Metabolites identified:
- not specified
Any other information on results incl. tables
Pharmacokinetic parameters in subjects (n = 7) following 600 mg quinine bisulphate
Subject | t 1/2 (h) | AUC (mg/L * h) |
1 | 8.25 | 38.4 |
2 | 8.67 | 35.2 |
3 | 6.40 | 56.9 |
4 | 11.09 | 62.1 |
5 | 8.13 | 52.6 |
6 | 8.17 | 59.9 |
7 | 6.93 | 72.0 |
Mean | 8.23 | 53.9 |
s.e. mean | 0.57 | 4.9 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study resultsThe AUC of quinine bisulphate was about 53.9 mg/L *h and the half-life in plasma is about 8.23 hours.
- Executive summary:
In the study published by Lockey, 1989 the pharmacokinetic of quinine bisulphate was determined after oral ingestion. The AUC of quinine bisulphate is 53.9 mgl/L *h and the half-life in plasma is 8.23 hours.
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