Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 211-309-7 | CAS number: 637-92-3
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Regarding the in vitro data, gene mutation tests with prokaryotes and mammalian cells and chromosome aberration tests with mammalian cells are available, all performed in accordance with or to a method similar to OECD guidelines and under GLP.
Four Ames test were available. The study of Pharmakon Europe (1994e) is selected as key study as most details were reported for this study. In that study ETBE was not mutagenic in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA98, TA 100 both in the absence and presence of S9 fraction. Additional strains (TA97(a) and TA102) were tested in some of the other studies and ETBE was also negative in these strains.
An in vitro HGPRT assay and an in vitro chromosomal aberration test both with in Chinese Hamster Ovary cells (Bushy Run Research Center (1995a/1995b) and performed according to methods similar to OECD guideline 476 and 473, respectively, were also negative.
In addition, extensive in vivo micronucleus data are available for ETBE which has been tested in the rat following repeat i.p. injection (Japan Bioassay Research Center, 2007a), repeat oral gavage (Japan Bioassay Research Center, 2007b), sub-chronic oral (drinking water) administration (Japan Bioassay Research Center, 2007c) and sub-chronic inhalation exposure (Japan Bioassay Research Center, 2007d). Data are also available for the mouse, obtained following single oral gavage administration (Bushy Run Research Center, 1995c) and sub-acute inhalation exposure (Institut Pasteur de Lille, 1992c). All investigations were Guideline- and GLP compliant. All returned negative results.
Short description of key information:
ETBE was negative in gene mutation tests in vitro (in prokaryotes and HGPRT with mammalian cells), in a chromosomal aberration test in vitro and in six in vivo micronucleus tests.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available negative data, ETBE is concluded to be non-mutagenic. In accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for mutagenicity.
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.
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