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EC number: 200-849-9 | CAS number: 75-21-8
- 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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- specific investigations: other studies
- Remarks:
- Concentration of the test substance in blood
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- It was the goal to determine the EO concentrations in blood of mice, rats, and volunteers exposed to various constant ethylene concentrations ranging from 1 up to 10,000 ppm in male B6C3F1 mice and male Fischer 344/N rats and from 5 up to 50 ppm in humans.
- GLP compliance:
- not specified
- Type of method:
- in vivo
- Endpoint addressed:
- basic toxicokinetics
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Linde, Unterschleißheim, Germany
- Purity: > 99.9% (ethylene oxide 3.0) - Species:
- other: mice and rat
- Strain:
- other: B6C3F1 and Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga Deutschland, Sulzfeld, Germany
- Weight at study initiation: 230-290 g (rats), 23-30 g (mice)
- Housing: Group housing of 2 (rats) or 5 (mice)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h - Route of administration:
- inhalation: vapour
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Animals were exposed to ethylene concentrations and ethylene oxide was measured in exhaled air and blood.
- Duration of treatment / exposure:
- 6 h
- Details on results:
- Half-lives of EO, estimated from the concentration-time courses of EO in blood at 30 ppm ET, were 8.9 min in mice and 15 min in rats. From the half-lives, elimination rate constants of 4.7 and 2.8/h were calculated for mice and rats, respectively. At identical ET exposure concentrations, EO concentrations are higher in rats than that in mice.
Data source
Reference
- Reference Type:
- publication
- Title:
- Ethylene Oxide in Blood of Ethylene-Exposed B6C3F1 Mice, Fischer 344 Rats, and Humans
- Author:
- Johannes Georg Filser, Winfried Kessler, Anna Artati, Eva Erbach, Thomas Faller, Paul Erich Kreuzer,
Qiang Li, Josef Lichtmannegger, Wanwiwa Numtip, Dominik Klein, Christian Pütz, Brigitte Semder, and
György Andras Csanady - Year:
- 2 013
- Bibliographic source:
- Toxicological Sciences 136 (2), 344-358 2013
- Report date:
- 2013
Materials and methods
- Study type:
- cohort study (prospective)
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- It was the goal to determine the EO concentrations in blood of mice, rats, and volunteers exposed to various constant ethylene concentrations ranging from 1 up to 10,000 ppm in male B6C3F1 mice and male Fischer 344/N rats and from 5 up to 50 ppm in humans.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethylene oxide
- EC Number:
- 200-849-9
- EC Name:
- Ethylene oxide
- Cas Number:
- 75-21-8
- Molecular formula:
- C2H4O
- IUPAC Name:
- oxirane
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Linde, Unterschleißheim, Germany
- Purity: > 99.9% (ethylene oxide 3.0)
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- HYPOTHESIS TESTED (if cohort or case control study): In order to provide a reliable basis for cancer risk assessment of ethylene, it was the goal to determine the ethylene oxide concentrations in blood
METHOD OF DATA COLLECTION
- Type: Clinical tests
- Details: Respiratory parameters were established by determining breathing frequencies and tidal volumes using a spirometer
STUDY PERIOD:
STUDY POPULATION
- Total number of subjects participating in study: 4
- Sex/age/race: Male/62, 49, 61, 42 years old
- Smoker/nonsmoker: Nonsmoker
- Total number of subjects at end of study: 4
HEALTH EFFECTS STUDIED
- Other health effects: Respiratory parameters
OTHER DESCRIPTIVE INFORMATION ABOUT STUDY: The shortest time interval between exposures was 2 days - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: inhalation
TYPE OF EXPOSURE MEASUREMENT: Area air sampling, venous blood sampling. EO concentrations in exhaled air were measured once an hour. Blood samples were taken at the start of the exposure and hourly thereafter
EXPOSURE LEVELS: 5, 20, and 50 ppm (3 males); 5 and 20 ppm (1 male)
EXPOSURE PERIOD: 4 h
Results and discussion
- Results:
- EXPOSURE
- Number of measurements: 3 measurements per participant for exhaled air and measured concentration in blood
- Average concentrations: 2.76, 6.76, 16.1, 2.32, 7.7, 26.6, 1.37, 7.42, 16.0, 1.71, 9.00 (exhaled air); 6.82, 23.6, 57.9, 6.87, 35.9, 81.8, 6.53, 32.7, 70.9, 6.90, 42.0 (blood)
- Standard deviation: 0.404, 1.58, 2.75, 0.316, 1.11, 2.24, 0.176, 0.471, 2.59, 0.020, 1.18 (exahled air); 0.818, 0.288, 3.44, 0.536, 7.29, 2.86, 0.599, 0.919, 12.2, 0.743, 9.60 (blood)
FINDINGS
OTHER OBSERVATIONS: The linear relationship between the EO concentration in blood and the ET concentration in air agrees with ealier findings showing that the rate of ET metabolism follows first-order kinetics up to an ET exposure concnetration of at least 50 ppm. - Strengths and weaknesses:
- Weakness: No negative control has been used
Applicant's summary and conclusion
- Executive summary:
The gaseous olefin ethylene (ET) is metabolized in mammals to the carcinogenic epoxide ethylene oxide (EO). Although ET is the largesl volume organic chemical worldwide, the EO burden in ET-exposed humans is still uncertain, and only limited data are availablc on thc EO burdcn in ET-exposcd rodents. Therefore, EO was quantified in blood of mice, rats, or 4 volunteers that were exposed once to constant atmospheric ET concentrations of
between 1 and 10000 ppm (rodents) or 5 and 50 ppm (humans).
Both the compounds were determined by gas chromatography.
At ET concentrations of between 1 and 10 000 ppm, areas under the concentration-time curves of EO in blood (μmol x h/l) ranged from 0.039 to 3.62 in mice and from 0.086 to 11.6 in rats. At ET
concentrations lower or equal to 30 ppm, EO concentrations in blood were 8.7-fold higher in rats and 3.9-fold higher in mice than that in the volunteer with the highest EO burdens. Based on measured EO concentrations,
levels of EO adducts to hemoglobin and lymphocyte DNA were calculated for diverse ET concentrations and compared with published adduct levels. For given ET exposure concentrations, there were good agreements between calculated and measured levels of adducts to hemoglobin in rats and humans and to DNA in rats and mice. Reported hemoglobin adduct levels in mice were higher than calculated ones. Furthermore, information is given on
species-specific background adduct levels. In summary, the study provides most relevant data for an improved assessment of the human health risk from exposure to ET.
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