Registration Dossier
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EC number: 204-685-9 | CAS number: 124-17-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A published study but one which contains sufficient experimental detail to be able to judge it reliable for risk and hazard assessment purposes
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolic studies with diethylene glycol monobutyl ether acetate (DGBA) in the rat
- Author:
- Deisinger PJ, Guest D
- Year:
- 1 989
- Bibliographic source:
- Xenobiotica, 19, 9, 981-9
Materials and methods
- Objective of study:
- excretion
- metabolism
- Principles of method if other than guideline:
- An in vivo study was conducted to determine the metabolic fate and disposition of the substance following a single oral gavage administration.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(2-butoxyethoxy)ethyl acetate
- EC Number:
- 204-685-9
- EC Name:
- 2-(2-butoxyethoxy)ethyl acetate
- Cas Number:
- 124-17-4
- Molecular formula:
- C10H20O4
- IUPAC Name:
- 2-(2-butoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Diethylene glycol monobutyl ether acetate (DGBA)
- Physical state: liquid
- Analytical purity: 95%
- Supplier: Kodak Laboratory CHemicals (ROchester, NY)
- Impurities (identity and concentrations): 2-(2-ethoxyethoxy)ethyl acetate, diethyl phthalate, methyl substituted DGBA.
- Radiochemical purity (if radiolabelling): 97.1%
- Specific activity (if radiolabelling): 0.951uCi/mole
- Locations of the label (if radiolabelling): no data
- Supplier: Wizard Laboratories (Davis, CA)
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- labelled material diluted with unlabelled as appropriate.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, MA
- Weight at study initiation: 200-250g
- Individual metabolism cages: yes/no
- Diet: Purina Chow 5002, ad libitum, except for first 4 hours after dosing.
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: labelled and unlabelled material blended to ensure that each dose contained approximately 20uCi.
- Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 and 2000mg/kg
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- yes
- Positive control reference chemical:
- No
- Details on dosing and sampling:
- METABOLITE CHARACTERISATION STUDIES using glassmetabolism cages.
- Tissues and body fluids sampled: urine, faeces, tissues, cage washes, exhaled air.
- Time and frequency of sampling: 8 (urine and CO2 only), 24, 48, 72hrs. Tissues from 72hrs when animals sacrificed.
- From how many animals: (samples pooled or not)
- Method type(s) for identification: Liquid scintillation counting. HPLC and GCMS for urine samples.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The substance was rapidly and completely absorbed from the gastrointestinal tract.
- Details on excretion:
- Radioactivity was eliminated rapidly in the urine. At the lower dose, 58% of applied dose was excreted by this route within 24 hours, whilst only 42% was similarly excreted from the high dose animals. In both cases, total accounted for dose in this period was 81-82%.. Only trace amounts of radioactivity were detected in the urine after 24hrs. See table below for distribution between excretion routes.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- 5 radiolabelled peaks identified accounting for 54% and 22% of the 0-8hr and 8-24hr urine collections respectively of the low dose animals. Similar results were seen in the high dose animals (41% and 39% for the first and second collection periods). A second major peak was observed in the higher dose animals as well as the single main peak seen in the low dose animals. Metabolites are shown in the table below.
Any other information on results incl. tables
Elimination Distribution betwen routes of elimination for 200mg/kg dose:
*negligible amount as VOC, all CO2. Total radioactivity recovery 97.4%
Distribution betwen routes of elimination for 2000mg/kg dose:
*negligible amount as VOC, all CO2. Total radioactivity recovery 100.6%
Metabolites Low dose animals (200mg/kg)
High dose animals (2000mg/kg)
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Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
2-(2-butoxyethoxy)ethyl acetate is eliminated almost entirely within 24 hours of even a very large dose. The main route of elimination is the urine. There is more than one potential metabolic route, although all involve the initial step of hydrolysis of the substance to its parent glycol ether. - Executive summary:
An in vivo study was conducted to determine the metabolic fate and disposition of the 2 -(2 -butoxyethoxy)ethyl acetate following a single oral gavage dose. Urinary metabolites were analysed and all other possible routes were also examined. The substance was rapidly and completely absorbed from the gastrointestinal tract and nearly all eliminated within 24hours, primarily in the urine. Dose had little effect on the pattern of metabolites or relative importance of the possible elimination routes. The main metabolite observed was 2 -(2 -butoxyethoxy)acetic acid. No butoxyacetic acid was detected nor any unchanged parent compound.
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