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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 203-438-2 | CAS number: 106-88-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Reference Type:
- other: manuscrpit
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The tandem mass spectrometric detection was done in the Selected Reaction Monitoring (SRM) mode. The SRM transitions used were m/z 210 to 152 and m/z 214 to 156 for hydroxypropylguanine (N7-HPG) and its [13C4]–labeled internal standard, respectively. Apurinic/apyrimidinc (AP) sites in DNA were measured following a procedure reported by: Nakamura, J, and Swenberg, JA. 1999. Endogenous apurinic/apyrmidinic sites in genomic DNA of mammalian tissues. Cancer Res. 59:2522-2526.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Dow chemical company Midland, Michigan 48674
- Type of assay:
- other: DNA adducts and Apurinic/apyrimidinc (AP) sites in DNA
Test material
- Reference substance name:
- Methyloxirane
- EC Number:
- 200-879-2
- EC Name:
- Methyloxirane
- Cas Number:
- 75-56-9
- Molecular formula:
- C3H6O
- IUPAC Name:
- 1,2-Epoxypropane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Lab. (Raleigh, North Carolina)
- Age at study initiation: 9-10 weeks
- Assigned to test groups randomly: yes
- Housing: one per cage
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 40-68
- Air changes (per hr): 12-15 times
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- none
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Whole body exposure chambers (Rochester-style):
The various concentrations of PO were generated using the glass J-tube method (Miller et al., 1980). Liquid test material was pumped into the glass J-tube assemblies (1 per exposure chamber) and vaporized by the flow of nitrogen gas passing through the bead bed of the glass J-tube. The nitrogen was heated as needed with a flameless heat torch (FHT-4, Master Appliance Corporation, Racine, Wisconsin) to the minimum extent necessary to vaporize the test material. All chambers, including the 0 ppm (control) chamber received the same amount (20 liters per minute) of supplemental nitrogen (carrier gas). The minimum amount of nitrogen necessary to reach the desired chamber concentrations was used. The generation system was electrically grounded and the J-tubes were changed as needed. The vaporized test material and carrier gas were mixed and diluted with supply air to achieve the desired test chamber concentration.
The animals were exposed to filtered air or PO vapors in 4 cubic meter stainless steel and glass Rochester-type whole-body exposure chambers [1.5 meters (m) x 1.5 m wide x 1.3 m deep with a pyramidal top and bottom]. Chamber airflow was maintained at a flow rate sufficient to provide the normal concentration of oxygen to the animals and 9-11 calculated air changes per hour. The chambers were operated at a slightly negative pressure, relative to the surrounding area. Animals were singly housed to minimize crowding during the exposure.
The chamber concentrations of PO, measured approximately in the center of the breathing zone of the animals, were determined at least once per hour with a Miran 1A infrared (IR) spectrophotometer (Foxboro/Wilks, South Norwalk, Connecticut) and reported by a strip chart recorder. The IR spectrophotometer was calibrated and a standard curve was compiled prior to and at the end of the study, using air standards prepared by vaporizing measured volumes of PO into Tedlar® sample bags (Series 233, SKC, Eighty Four, Pennsylvania) along with the metered volumes of dry, compressed air. - Duration of treatment / exposure:
- 6 hr/day
- Frequency of treatment:
- 5 days/ week for 4 consecutive weeks
- Post exposure period:
- none
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 ppm (nominal)
- Dose / conc.:
- 100 ppm (nominal)
- Dose / conc.:
- 200 ppm (nominal)
- Dose / conc.:
- 400 ppm (nominal)
- No. of animals per sex per dose:
- 16/exposure level
- Control animals:
- yes, concurrent no treatment
Examinations
- Tissues and cell types examined:
- nose, respiratory epithelium, liver, spleen and lung.
- Details of tissue and slide preparation:
- DNA was isolated from liver, spleen, and lung by the Gentra Puregene System.
The DNA from nasal respiratory epithelium was isolated by phenol/chloroform extraction - Evaluation criteria:
- Quantitation was based on comparisons to internal standard DNA containing known amounts of AP sites, calibrated with DNA from Kubo et al. (6).
Calibration curves were generated by using the standard solutions prepared by spiking varying amounts of 7-HPG into the solutions that contained a constant amount of internal standard. Solvent control was applied per sample set in order to avoid contamination of regents. - Statistics:
- AP site measurement based on Dunnett’s multiple comparisons analysis.
Results and discussion
Test resultsopen allclose all
- Sex:
- male
- Genotoxicity:
- other: A dose-related increase for N7-HPG (a biomarker of exposure) was seen from 50 ppm onward, the higets levels in the nasal repiratory epithelium.
- Toxicity:
- yes
- Remarks:
- reduced bw gain at the highest dose only; 400 ppm
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Sex:
- male
- Genotoxicity:
- other: no significant differences in the number of AP sites in DNA from nasal respiratory epithelium
- Toxicity:
- yes
- Remarks:
- reduced bw gain at the highest dose only; 400 ppm
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Additional information on results:
- The 7-HPG adducts form 50 ppm onward PO exposure concentration and the linear dose-response relationship was noted.
AP site determination found that there were no significant differences in the number of AP sites in DNA from nasal respiratory epithelium, across the dose groups.
Any other information on results incl. tables
Clearly the target tissue, nasal respiratory epithelium, receives the highest dose of N7-HPG, as expected for the site-of-contact tissue.
The N7-HPG levels in other tissues examined were slightly higher in mice than in rats exposed to the same air concentrations at the high exposures (200 and/or 400 ppm).
Exposure did not cause an increase in AP sites in respiratory nasal mucosa, despite the high number of N7-HPG adducts. HPG is not considered to be a promutagenic DNA adduct. However, it is chemically unstable, resulting in chemical depurination and the formation of an AP site. The fact that AP sites were not increased with increasing exposure demonstrates that AP sites resulting from such chemical depurination do not lead to unbalanced DNA repair.
Applicant's summary and conclusion
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.
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