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Diss Factsheets
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EC number: 221-410-8 | CAS number: 3087-36-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable study with sufficient documentation which meets basic scientific principles. Read-across justification: The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the toxicokinetics of target substance. Because of the rapid hydrolysis, the influence of the mode of administration through inhalation, dermal and oral is related to the hazardous degradation product (alcohol) released from the target substance. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance, which might change the hazardous properties of the target substance compared to the properties of the pure alcohol. As there is a mechanistic reasoning to the read-across, the unnecessary animal testing is avoided by using the read-across data from the degradation product (relevant alcohol) to evaluate irritation, sensitization and the short term and long-term toxicological effects and mutagenicity of the target substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Biomonitoring, Performance and Well-Being under Exposure to Inhalation of Ethanol.
- Author:
- Seeber, A., Blaszkewicz, M., Kiesswetter, E., Bandel, T., Golka, K., Heitmann, P., Vangala, R.R., Bolt, H.M.
- Year:
- 1 994
- Bibliographic source:
- Transact German Soc Occup & Environ Med. 34th Ann Meet, Weisbaden, 1994
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Human volunteer study examining blood ethanol concentrations resulting from differing inhalation exposures to ethanol vapour.
- GLP compliance:
- not specified
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:
- - No further data
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Strain:
- other: Assumed Caucasian
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- 4 hour(s)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Males: 150 mg/cu m; 750 mg/cu m and 1500 mg/cu m; and exceeding MAK Females: 150 mg/cu m; 750 mg/cu m and 1500 mg/cu m and exceeding MAK
- No. of animals per sex per dose / concentration:
- Males: 12 Females: 12
- Control animals:
- no
- Statistics:
- Statistical tests included analysis of variance, F-test and correlation coefficients.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- See remarks on results below.
- Details on distribution in tissues:
- not examined
- Details on excretion:
- not examined
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Blood alcohol levels were between 0.00023 and 0.0021 mg/ml in the first series and 0.00066 and 0.0056 mg/ml in the second (Units of concentration not clear in results). There was a very good correlation between inhalation exposure concentrations and resultant blood ethanol concentrations.
In both experiments there were no significant exposure-related effects in the psychological performance variables in both men and women. In the second experiments where concentrations varied about the MAK there were no significant effects at and below the MAK but at concentrations above the MAK (1000ppm), exposure was 'troublesome' (interpreted as caused discomfort to the volunteers).
The highest dose was below the prevailing MAK value of 1900 mg/cu m (= 1000 ppm) and it is concluded that the maximum blood alcohol level will remain below 0.001% both in men and in women. Regression analysis of the data shows that the blood ethanol concentration (BEC) can e modeled using the following equation: It follows from this result of a linear relationship between BEC and exposure concentration that the kinetics of elimination are first order and that metabolism is not saturated.
[BEC] (ppm) = [Exposure (ppm)] x 0.0029 (with a 7% error for 95 % confidence).
Adverse effects on prolonged exposure: no significant effects.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
In this human volunteer study it was established that exposures of up to 2000 ppm of ethanol for periods of up to 4 hours do not saturate metabolism and that elimination kinetics are first order. - Executive summary:
In a human volunteer study using 24 men and women, it was established that exposures of up to 2000 ppm of ethanol for periods of up to 4 hours do not saturate metabolism and that elimination kinetics are first order. A linear relationship was established between exposure concentration and resultant blood ethanol concentrations, leading to the prediction that the a maximum blood ethanol concentration of 2.9 mg/l results from an (indefinite) exposure to 1000 ppm of ethanol.
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.
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