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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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- 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:
- chronic toxicity: inhalation
- 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:
- The current study was designed to investigate the mutagenic potential of EO and PO in monkeys following 2-year exposures under controlled experimental conditions.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Purity: 99.7%
- Physical appearance: gas - Species:
- monkey
- Strain:
- Macaca fascicularis
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 60 adult male cynomolgus monkeys were randomly assigned to 5 groups, each consisting of 12 monkeys. A shared common control group was employed. Body weight was 5.31 +/- 0.82 kg at the start of the study. The monkeys were housed in stainless-steel housing cages with automatic watering in animal rooms except during the exposure period. A 12 h on : 12 h off lighting system was maintained. Monkeys were fed a standard pellet diet of Purina, once daily at the end of the exposure day, with fresh fruit provided 2 - 3 times per week. Water was provided ad libitum except during exposures.
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- Control monkeys were exposed in chambers to filtered air. 50 ppm concentrations were selected since they were the current federal workplace standards for EO, at the time the exposures were started. EO 100 ppm concentrations were chosen since they approximate maximum tolerated airborne concentrations for monkeys.
Animal exposures were conducted using 4.5-m3 stainless-steel and glass inhalation chambers. Chambers were operated under dynamic flow conditions with tangential airfeed manifolds maintained at 40 liters/min with a pressure of -0.25 cm water. Chamber airflows provided 12 - 15 air changes/hr. Temperature and humidity were maintained at 24 +/- 3°C and 50 +/- 10%, respectively. EO was vaporized using an Atinco EO vapor generator, and the vapors were metered into the filtered air intake of the chamber. Chamber concentrations were monitored 2 to 4 times per hour in an infrared analyzer. Charcoal tube samples of the test atmospheres analyzed by gas chromatography verified that the chamber concentrations were within 10% of the target values, and that the control chamber atmosphere was free of EO.
Blood collection: About 4 ml blood was collected from the femoral vein of each monkey while the animal was tranquilized following im ketamine hydrochloride. Blood was immediately placed in sterile stoppered tubes, two per animal, containing 0.1 ml sodium heparin, mixed thoroughly for at least 15 min, and stored at room temperature until cultured. Blood collections were initiated during the final month of exposure and were completed prior to the termination of the 2-year exposures. - Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- 7 h/d, 5 d/w
- Dose / conc.:
- 50 ppm
- Dose / conc.:
- 100 ppm
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
- Details on results:
- Monkeys, with the exception of the EO 100 ppm group, tolerated the exposures well. The EO 100 ppm group had a statistically significant reduced mean body weight compared to the control group beginning at Week 19 and continuing through Week 104. Five monkeys died during the 2-year exposures, one each in the EO 50 and EO 100 ppm groups. These deaths did not appear to be related to oxide exposure. In addition, 10 monkeys, 2 per group, were killed at the termination of exposures. The remaining 44 monkeys are still being maintained and are being examined quarterly for body weight and hematological changes.
- Dose descriptor:
- NOAEC
- Effect level:
- < 50 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
- Critical effects observed:
- no
Data source
Reference
- Reference Type:
- publication
- Title:
- Sister-Chromatid Exchanges and Chromosome Aberrations in Lymphocytes from Monkeys Exposed to Ethylene Oxide and Propylene Oxide by Inhalation.
- Author:
- Lynch, D.W., Lewis, T.R., Moorman, W.J., Burg, J.R., Gulati, D.K., Kaur, P., Sabharwal, P.S.
- Year:
- 1 984
- Bibliographic source:
- Tox. Appl. Pharmacol. 76, 85 - 95
Materials and methods
- Principles of method if other than guideline:
- The current study was designed to investigate the mutagenic potential of EO and PO in monkeys following 2-year exposures under controlled experimental conditions.
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay
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:
- - Physical appearance: gas
- Purity: 99.7%
Test animals
- Species:
- monkey
- Strain:
- Macaca fascicularis
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- 7 h/d, 5 d/w
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 ppm (nominal)
- Dose / conc.:
- 100 ppm (nominal)
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent no treatment
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- ambiguous
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Toxic effects of the EO exposure were encountered during attempts to culture blood samples from EO-exposed monkeys. In 1 out of 11 animals exposed at 50 ppm EO and 3 out of 12 monkeys exposed at 100 ppm EO, there were minimal (if any) mitosis. In one of these three EO 100 ppm monkeys, where only two metaphases could be evaluated, the SCEs/metaphase were 20 and 42, respectively. Further attempts employing different culture times and varying phytohemagglutinin concentrations and sources were also unsuccessful.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test substance revealed an ambiguous test result under the conditions chosen in the sister chromatid exchange assay and chromosome aberration assay.
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