Registration Dossier
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EC number: 231-640-0 | CAS number: 7665-72-7
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Study period:
- 1984-11-08
- Justification for type of information:
- Read-across
Data source
Reference
- Reference Type:
- publication
- Title:
- The metabolism of n-butyl glycidyl ether in the rat and rabbit
- Author:
- Eadsforth CV
- Year:
- 1 984
- Bibliographic source:
- Eadsforth, C. V., D. H. Hutson, C. J. Logan, and B. J. Morrison. "The metabolism of n-butyl glycidyl ether in the rat and rabbit." Xenobiotica 15, no. 7 (1985): 579-589.
- Report Date:
- 1984
Materials and methods
- Principles of method if other than guideline:
- - Principle of test: Elimination of test item in rats and rabbits and the identification of major urinary metabolites, which may provide the basis of amethod for exposure monitoring
- Short description of test conditions: Animals given a single oral dose of test item, housed individually and fed with food and water ad libitum.
- Parameters analysed / observed: elimniation and retention of n-BGE. - GLP compliance:
- no
Test material
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Fluorochem Ltd (Dinting Lane, Glossop, Derbyshire, UK); [1-14C]Butyl glycidyl ether supplied by ICI Radioisotope Section (Billingham, Cleveland, UK)
- Expiration date of the lot/batch: Not reported
- Purity test date: Not reported
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: >98%, as measured by radio g.l.c.
- Specific activity: 3.52 Ci/mol (total activity 2.4 mCi)
- Locations of the label: Not reported
- Expiration date of radiochemical substance: Not reported
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored under argon at 4°C
- Stability under test conditions: Not reported
- Solubility and stability of the test substance in the solvent/vehicle: Not reported
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: diluted in corn oil (Rats); double-gelatin capsule (Rabbit)
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel: 41 mg n-butyl glycidyl ether and 15 mg 14C-n-butyl glycidel ether made up to 2.5 mL corn oil (Rats); 160 ul 14C-n-butyl glycidyl ether and 63 mg n-butyl glycidyl ether dispensed into a double-gelatin capsule
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Dissolved in corn oil (Rat); Double-gelatin capsule (Rabbit)
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre, Rodent Breeding Unit
- Age at study initiation: Not reported
- Weight at study initiation: 250 g
- Housing: Housed individually in numbered plastic metabowls
- Diet (e.g. ad libitum): PRD pellets (Labsure Animal Diets LTd, Poole, Dorset, UK)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: starved overnight before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour night
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
13C-nBGE (5.6 mg, equiv. to approx. 20 mg/kg body weight, 42.3 uCi) in corn oil (0.25) in a Hamilton 1000 ul gas-tight glass syringe - Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Dose / conc.:
- 20 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 5
- Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine, faeces
- Time and frequency of sampling: collected during 24 hour periods for 3 days at room temperature
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled (delete / add / specify): urine, faeces
- Time and frequency of sampling: collected during 24 hour periods for 3 days at room temperature
- From how many animals: (samples pooled or not) : pooled; 5 rats
- Method type(s) for identification: HPLC, hydrolysis, analytical thin-layer chromatography, liquid-scintillation, nuclear magnetic resonance spectroscopy, mass spectrometry
Results and discussion
- Preliminary studies:
- N.A.
Main ADME resultsopen allclose all
- Type:
- excretion
- Results:
- 87% excreted in urine within 24h
- Type:
- excretion
- Results:
- 92% excreted in urine within 96h
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- N.A.
- Details on distribution in tissues:
- N.A.
- Details on excretion:
- Further elimination of the administered radioactivity over the three days following 24 hours post-administration was minmal.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Metabolite A (butyoxyacetic acid): 10% excreted, Rf value = 0.92
Metabolite D (p-bromphenacyl ester of 3-butoxy-2-acetylaminopropionic acid): 23% excreted, Rf value = 0.75
Metabolite E (p-bromophenacyl ester of 3 butoxy-2-hydroxypropionic acid): 9% excreted, Rf value = 0.68
Metabolite F (decomposed to amore polar metabolite and no further work was done to identify the compound): 19% excreted, Rf value = 0.57
Applicant's summary and conclusion
- Conclusions:
- [l-14C]Butyl glycidyl ether when administered to rats or rabbits as a single oral dose (20mg/kg) was rapidly absorbed and eliminated as a complex mixture of metabolites in the urine. The major urinary metabolites were identified as 3-butoxy2-hydroxypropionic acid, 3-butoxy-2-acetylaminopropionic acid and butoxyacetic acid. The structures of the identified products show that a major route of biotransformation of n-butyl glycidyl ether in rat was via hydrolytic opening of the epoxide ring followed by oxidation of the resulting diol to 3-butoxy-2-hydroxypropionic acid and subsequent oxidative decarboxylation to give butoxyacetic acid. Another major metabolite, 3-butoxy-2-acetylaminopropionic acid is novel, and the authors conclude that these reactions represent efficient detoxication of this molecule.
- Executive summary:
[l-14C]Butyl glycidyl ether when administered to rats or rabbits as a single oral dose (20mg/kg) was rapidly absorbed and eliminated as a complex mixture of metabolites in the urine. This test item was used as read-across substance for tert-butyl glycidyl ether. The major urinary metabolites were identified as 3-butoxy2-hydroxypropionic acid, 3-butoxy-2-acetylaminopropionic acid and butoxyacetic acid. The structures of the identified products show that a major route of biotransformation of n-butyl glycidyl ether in rat was via hydrolytic opening of the epoxide ring followed by oxidation of the resulting diol to 3-butoxy-2-hydroxypropionic acid and subsequent oxidative decarboxylation to give butoxyacetic acid. Another major metabolite, 3-butoxy-2-acetylaminopropionic acid is novel, and the authors conclude that these reactions represent efficient detoxication of this molecule.
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