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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-376-4 | CAS number: 2426-08-6
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- distribution
- excretion
- metabolism
- toxicokinetics
- Principles of method if other than guideline:
- The disposition of [14C]-labeled n-butyl glycidyl ether (BGE) was studied in rats and mice.
Male and female rats and mice were dosed by gavage. Urine and faeces were collected 24 hours after dosing. Excretion of the substance in urine and faeces was measured and also in expired air for male rats and male and female mice. Tissue distribution was assessed, based on radioactivity and metabolites were identified in urine. - GLP compliance:
- no
- Specific details on test material used for the study:
- [n-Butyl-1'-14C]-BGE (specific activity, 55 mCi/mmol; radiochemical purity, 99.7%)
- Radiolabelling:
- yes
- Species:
- other: Rats and Mice
- Strain:
- other: Fischer 344 and B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Rats:
- Source: Charles River Laboratories (Kingston, NY)
- Age at study initiation: Males 11.5–12.5 weeks old, and females 13 weeks old
- Weight at study initiation: Males 233–276 g, and females 179–196 g
- Housing: individually in metabolism cages allowing for the collection of urine, feces, and expired air
- Diet:National Institutes of Health #31, ad libitum
- Water: ad libitum
Mice:
- Source: Charles River Laboratories (Raleigh, NC)
- Age at study initiation: Males 8 weeks old, and females 7-9 weeks old
- Weight at study initiation: Males 24–27 g, and females 19–22 g
- Housing: individually in metabolism cages allowing for the collection of urine, feces, and expired air
- Diet:National Institutes of Health #31, ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Dose volume: rats 5 mL/kg; mice 10 mL/kg
- Duration and frequency of treatment / exposure:
- single administration
- Dose / conc.:
- 2 mg/kg bw/day (actual dose received)
- Remarks:
- Male rats and female mice
- Dose / conc.:
- 20 mg/kg bw/day (actual dose received)
- Remarks:
- Male rats and female mice
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Remarks:
- Male rats and female mice
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Remarks:
- Female rats and male mice
- No. of animals per sex per dose / concentration:
- 4 or 5
- Details on dosing and sampling:
- Urine and feces were collected 24 h following dosing. The metabolism cages were rinsed with distilled water at the end of each study to increase urine recovery. Urine aliquots were counted for 14C in a liquid scintillation counter and the remainder was stored at -20 °C. Feces were air-dried, weighed, and ground to a powder using a ceramic mortar and pestle. The amount of BGE-derived radioactivity in expired air was determined for male rats receiving a single 20-mg/kg p.o. dose and in both male and female mice.
After the animals were euthanized by CO2 asphyxiation, blood was drawn by cardiac puncture, and the following tissues were collected: liver, kidney, lung, pancreas, thyroid, thymus, adrenal glands, abdominal muscle, skin (ear pinna), fat (abdominal), brain, testes or uterus, forestomach, glandular stomach, small intestine, and large intestine. All the tissue weights were determined gravimetrically, except blood, fat, skin, and muscle, which were estimated to be 8, 11, 16, and 50% of total body weight, respectively.
Tissue and feces aliquots (triplicate 50–100-mg samples from rats,up to 100 mg from mice) were oxidized and counted in the liquid scintillation counter for determination of total 14C.
Urine collected 24 h post-dosing from male rats dosed p.o. with BGE (200 mg/kg) was analyzed by the HPLC with radiochemical detection to reveal 13 radio-labeled peaks. The metabolites were not observed by UV detection, so the isolation of these urinary metabolites was accomplished by collection of HPLC fractions at 1-min intervals between 8 and 28 min and the metabolites were characterized by MS and 1H NMR. - Type:
- excretion
- Results:
- Excretion, rats: urine 84–92% within 24 h, feces: 2.6 –7.7%, expired air (0.1% volatiles and 1.5% CO2, 20 mg/kg), remained in the tissues (1.8–4.4%). Excretion, mice: urine 64-73%, feces 5.3-12%, expired air 10-18% as CO2.
- Details on distribution in tissues:
- The BGE-derived radioactivity remaining in tissues 24 h after dosing with 2 to 200 mg/kg accounted for less than 5% of the dose. The concentration of BGE-derived radioactivity in glandular and forestomach is high in mice. Tissue distribution data were obtained for 2 and 20 mg/kg doses for male rats and female mice. The distribution is generally dose-proportional, and with the exception of forestomach, the data for the 200-mg/kg dose adequately describe the distribution of lower doses. Forestomach concentration after a p.o. dose of 2, 20, and 200 mg/kg was 42, 530, and 1770 nmol/g in female mice and 9.6, 90, and 323 nmol/g in male rats.
- Details on excretion:
- Most of the dose (2–200 mg/kg) administered to male and female rats was excreted in urine (84–92%) within 24 h. The rest of the dose was excreted in feces (2.6 –7.7%), expired air (0.1% volatiles and 1.5% CO2, 20 mg/kg), or remained in the tissues (1.8–4.4%). There is no obvious dose effect on disposition among the range of doses (2–200 mg/kg) in male rats. Female rats have less of the dose remaining in tissues compared with males. Most of the dose given to male and female mice was also excreted in urine (64–73%). Mice appeared to excrete a larger percentage of the dose in feces (5.3–12%), but separation of urine and feces in mouse metabolism cages was not complete, and contamination of urine with feces occurred in some experiments. Mice excreted a larger percentage of the p.o. dose in expired air as 14CO2 (10–18%) and had less remaining in the tissues (1.5–1.7%) than rats within 24 h. Mice that received a 200-mg/kg dose excreted more 14CO2 than the lower dose treatment (2 and 20 mg/kg). The total recovery was 93 to 98% for rats and 88 to 97% for mice.
- Metabolites identified:
- yes
- Details on metabolites:
- No parent BGE was detected in rat or mouse urine. Fifteen urinary metabolites were identified, including 3-butoxy-2-hydroxy-1-propanol and its monosulfate or monoglucuronide conjugates, 3-butoxy-2-hydroxypropionic acid, O-butyl-N-acetylserine, butoxyacetic acid, 2-butoxyethanol, and 3-butoxy-1-(N-acetylcystein-S-yl)-2-propanol, the mercapturic acid metabolite derived from conjugation of glutathione (GSH) with BGE at the C-1 position. Some of these metabolites underwent further ω-1 oxidation to form a 3'-hydroxybutoxy substitution. One urinary metabolite was from ω-oxidation of 3-butoxy-1-(N-acetylcystein-S-yl)-2-propanol to yield the corresponding carboxylic acid. Oxidative deamination of 3-butoxy-1-(cystein-S-yl)-2-propanol gave the corresponding α-keto acid and α-hydroxy acid metabolites that were present in mouse urine but not in rat urine. An in vitro incubation of BGE with GSH showed that the conjugation occurred only at the C-1 position with or without the addition of GSH S-transferase.
Reference
Description of key information
Most of the dose administered to the rats was excreted in urine (84–92%) within 24 h. The rest was excreted in feces (2.6 –7.7%), expired air (0.1% volatiles and 1.5% CO2, 20 mg/kg), or remained in the tissues (1.8–4.4%).
Most of the dose given to male and female mice was also excreted in urine (64–73%). Mice appeared to excrete a larger percentage of the dose in feces (5.3–12%). Mice excreted a larger percentage of the p.o. dose in expired air as 14CO2 (10–18%) and had less remaining in the tissues (1.5–1.7%) than rats within 24 h. Mice that received a 200-mg/kg dose excreted more 14CO2 than the lower dose treatment (2 and 20 mg/kg).
The total recovery was 93 to 98% for rats and 88 to 97% for mice.
Key value for chemical safety assessment
Additional information
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.