Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-578-6 | CAS number: 64-17-5
- 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: Not a guideline study and not performed according to GLP, but data scientifically acceptable and well reported
Data source
Reference
- Reference Type:
- publication
- Title:
- Excretion of low-molecular weight volatile substances in human breath: focus on endogenous ethanol
- Author:
- Jones AW
- Year:
- 1 985
- Bibliographic source:
- J Anal Toxicol 9: 246-250
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- To investigate the elimination kinetics of a small oral dose of exogenous ethanol in a healthy individual.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- - Name of test material (as cited in study report): ethanol
- Physical state: Liquid
- Analytical purity: 99.6% v/v
- Other: Ethanol obtained from Vin och Spritcentralen Ltd
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- One healthy volunteer
Administration / exposure
- Route of administration:
- other: oral
- Vehicle:
- other: diluted with orange juice
- Details on exposure:
- Volunteer drank 5 g of ethanol diluted to 100 mL with orange juice
- Duration and frequency of treatment / exposure:
- Single
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.077 g/kg bw
- No. of animals per sex per dose / concentration:
- 1 male
- Control animals:
- no
- Positive control reference chemical:
- none
- Details on dosing and sampling:
- Breath sampling. The volunteer was instructed to take a moderately deep inhalation and to exhale as much breath as possible. At the end of exhalation a sample of breath was captured. This end-expired alveolar air was analysed with a model 104-gas chromotograph equipped with a flame ionization detector. A model 2091 mass spectrometer was used to record the mass spectra of endogenous ethanol. The blood:breath partition ratio for ethanol in vivo was taken as 2300:1.
- Statistics:
- no data
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Blood ethanol concentrations were estimated from breath analysis (end-expired alveolar air) of the healthy volunteer over time, following consumption of 5 g ethanol. Elimination kinetics showed that pre-drink endogenous blood ethanol levels (of about 0.07 to 0.39 µg/L; estimated from another experiment involving 10 healthy male volunteers) were increased about 200-fold following consumption of this low-dose of ethanol. The elimination of exogenous ethanol took just over 2 hr, with a half-life of about 16 minutes.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
When a healthy male volunteer drank 5 g ethanol (about 0.077 g/kg bw), the blood concentration of ethanol was estimated to have increased about 200-fold above the endogenous levels. The elimination of exogenous ethanol took just over 2 hours, with a half-life of about 16 minutes. - Executive summary:
- Blood ethanol concentrations (assuming a blood:breath partition ratio in vivo of 2300:1) were estimated from breath analysis of a healthy male volunteer over time after consumption of 5 g ethanol (about 0.077 g/kg bw) diluted in orange juice, following an overnight fast. Elimination kinetics showed that pre-drink endogenous blood ethanol levels (of about 0.07 to 0.39 µg/L; estimated from another experiment involving 10 healthy male volunteers) were increased about 200-fold following consumption of this low-dose of ethanol (about half a typical alcoholic beverage). The elimination of exogenous ethanol took just over 2 hr, with a half-life of about 16 minutes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.