Registration Dossier
Registration Dossier
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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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Value:
- 3 mg/m³
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 500
- Dose descriptor:
- T25
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
The most critical effect is tumorigenicity. Butylene oxide has caused nasal and lung tumors in rats (2 years inhalation). This indicates that Butylene oxide is a potential carcinogen, at least at high concentrations at the port of entry. Inhalation appears to be the most important route of exposure and the resultes 2 years inhalation study (see below) provide a basis for a quantitative estimation of the risk of exposure. For dermal exposure such data are lacking. On the other hand, skin exposure does not appear to be a common route of exposure and the high vapour pressure and volatility of the material and its irritating properties indicate that dermal exposure will be minimal. Therefore, no DNELs/DMELs were derived for dermal exposure. Furthermore, no DNELs/DMELs are proposed for acute exposure for the material is a local carcinogen at the port of entry and with effects being concentration dependent and no data are available so far which would definitely support for acute exposures a clearly higher concentration than the chronic DMEL. The chronic DMEL is based on the local tumours obtained at the port of entry. It is further proposed that the DMEL derived for these local tumours provides also sufficient protection from any systemic effects.
The following tumor incidences were obtained in male rats:
Dose | Nasal adenoma | Lung adenoma plus carcinoma |
0 ppm | 0 | 0 |
200 ppm | 0 | 8.9% |
400 ppm | 24.2% | 17.6% |
At 400 ppm there was a markedly decreased survival in male rats. In females, a low tumor response was seen only at 400 ppm. For the nasal tumors in males a T25 of 413 ppm is obtained. For lung tumors in males a T25 of 568 ppm (calculated from the top dose) or 562 ppm (calculated from the lower dose ) is obtained. A linear extrapolation from a T25 of 500 ppm as a point of departure would indicate a numerical risk of 1:2000 at 1 ppm. However, the real risk is assumed to be lower due to a likelyhood for non-linear elements in the dose response relation at lower doses (as has been shown for propylene oxide). 1 ppm (= 3 mg/m3) can therefore serve as a preliminary DMEL for butylene oxide.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
No DNEL/DMEL is proposed for the general population, since the material is not foreseen in consumer products.
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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