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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 213-701-3 | CAS number: 1003-14-1
- 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 somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given, comparable to guideline/standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- 1,2-epoxybutane
- EC Number:
- 203-438-2
- EC Name:
- 1,2-epoxybutane
- Cas Number:
- 106-88-7
- Molecular formula:
- C4H8O
- IUPAC Name:
- 2-ethyloxirane
- Details on test material:
- purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- All the animals were located in a room which was separate from but adjacent to the area where the exposures were conducted. They were housed individually in cages in a room with a light intensity of approximately 200 lux, a 12 h light-dark cycle, approximately 10 air changes per hour, temperature maintained at ca 22°C with extreme limits of 23.5°C and 17°C, and relative humidìty ca 50%, with extreme limits of 60% and 32% in the completed portions of the experiment.
The rats designated for cytogenetic analysis were housed in suspended polycarbonate cages measuring 24 x 18 x 41 cm with steel mesh tops and bottoms. The cages were suspended over trays lined with absorbent paper.
Food and water were freely available to the rats at all times.
The animals to be dosed were individually identified using bress ear tags bearing the animal number and suffix letter showing the compound designat. Each rat was ascribed a cage card which identified that animal by project number, animal number, sex and treatment group.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- air
- Details on exposure:
- The test atmospheres were produced by bubbling dry, oxygen-free nitrogen (BOC Limited) through a liquid reservoir of butylene oxide contained in a glass washing, or Drechsel bottle immersed in a temperature controlled water bath at 28°C. The nitrogen/butylene oxide vapour mixturer so generated was ducted through a vertical stainless steel piping approximately 1.5 m long to a glass mixing vessel and diluted with filtered, compressed air. The resulting mixture of butylene oxide/air was ducted through a 3/4" ID stainless steel tube to the apex of the exposure chamber.
The atmospheres in the exposure chambers were dynamic in that they were continuously generated for a single pass through the animal holding zone,before being extracted from the bottom and ducted away for 'scrubbing'. The required atmospheric concentrations within the exposure chambers were maintained by finely regulating the flow of nitrogen and diluting air into the mixing vessels, by means of adjustable flow meters.
The chamber temperature and relative humidity were recorded at hourly intervals through the exposure period. The animals were also observed at regular intervals for the appearance of clinical signs or adverse reactions to treatment. On completion of the exposure period and purging of the chamber of test compound, the animals were removed from the exposure chamber and returened to the animal holding area. The animals were then removed from their individual compartments, observec for clinical signs, ear numbers checked, body weights recorded and returned to their cages. - Duration of treatment / exposure:
- 7 single exposures for 5 consecutive days
- Frequency of treatment:
- 7 single exposures for 5 consecutive days
- Post exposure period:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
250, 1000 ppm (0.75, 3.0 mg/l)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- other: yes; air control group
- Positive control(s):
- Ethyl methanesulphonate (EMS)
Examinations
- Statistics:
- A one-sided Student's t test was used on the transformed values.
This analysis was performed (a) including all abnormalities and (b) excluding cells only exhibiting gaps.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the multiple exposure cytogenetic test, there were no indications of induction of chromosomal damage in either male or female rats exposed to 250 ppm or 1,000 ppm butylene oxide atmospheres.
On the other hand, treatment with 100 mg EMS/kg/day for 5 days induced large increases in the frequencies of cells with chromatid damage. In both male and female rats this damage included gaps as well as chromatid breaks with fragments.
In the single exposure test rats treated with ethyl methanesulphoate, there were significant increases in aberrant cell frequencies in males and females at the 6 h and 24 h sampling times and in the females at the 48 h sampling time. There was no significant response in the 48 h sampling time males. Theses responses were significant if all aberrant cells were analyzed or if cells containing only gaps were discarded. The damage was mainly to chromatids and there was a tendency for damage other than gaps to appear in the 24 h samples.
Butlyene oxide exposure groups did not show any increase in the frequency of aberrant cells except in the 6 h sample time males exposed to 1000 ppm butylene oxide. If cells only containing gaps were excluded from the analysis, then the statistical significance of the difference from the air control group was reduced.
This result with butylene oxide is probably insufficient evidence on which to base a conclucion for the clastogenic potential of this compound in vivo: the effect was small and was not observed in female rats.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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.