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Diss Factsheets
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EC number: 203-629-0 | CAS number: 108-91-8
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmacokinetics, carciovascular and metabolic actions of cyclohexylamine in man
- Author:
- Eichelbaum M, Hengstmann JH, Rost HD, Brecht T, Dengler HJ
- Year:
- 1 974
- Bibliographic source:
- Arch Toxicol 31, 243-263
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Cyclohexylamine was administered orally in doses of 2.5, 5, amd 10 mg/kg bw to 11 healthy volunteers to determine absorption, plasma half lives, excretion, and biochemical effects
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyclohexylamine
- EC Number:
- 203-629-0
- EC Name:
- Cyclohexylamine
- Cas Number:
- 108-91-8
- Molecular formula:
- C6H13N
- IUPAC Name:
- cyclohexanamine
- Details on test material:
- cyclohexylamine purissimum adjusted with hydrochloric acid to a pH of about 7 (no further data)
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- other: medical or laboratory staff members familiar with Cyclamate/cyclohexylamine problem
- Sex:
- male
Administration / exposure
- Route of administration:
- other: oral (total dose at once)
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.5, 5, 10 mg/kg bw
- No. of animals per sex per dose / concentration:
- total number : 11 male healthy volunteers; they fasted over night and did not take any food or fluid during the first 4 hours of the experiment.
They were lying in a quiet room 30 min before and 4 hours after ingestion of the testsubstance - Control animals:
- not specified
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Almost complete enteral absorption
- Type:
- excretion
- Results:
- 86 -95 % of the administered doses were excreted in the urine during 48 hours as unchanged compound
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- levels of cyclohexylamine could be observed already 15 min after the administration.
Peak levels were obtained 90-120 min after dosing; thereafter the falll in plasma cyclohexylamine was shown to be linear when plotted on a semilogarithmic scale - Details on distribution in tissues:
- no data
- Details on excretion:
- no further data
Toxicokinetic parameters
- Toxicokinetic parameters:
- other: half life in plasma ranged from 3.5 -4.8 hours:clear dose dependency
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
Cyclohexylamine caused a dose dependent rise in arterial blood pressure . A close correlation between plasma level of CHA and increase in mean arterial blood pressure could be established. A significant increase in fatty acids and cumulative urinary excretion of catecholamine was observed only after the administration of 10 mg/kg bw.
Applicant's summary and conclusion
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