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EC number: 203-919-7 | CAS number: 111-90-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 2001 to November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted with guideline equivalent protocol
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethanol
- EC Number:
- 203-919-7
- EC Name:
- 2-(2-ethoxyethoxy)ethanol
- Cas Number:
- 111-90-0
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Transcutol HP (source sponsor); 4- 14C-Diethylene glycol monoethyleter (source Moraveck Biochemicals Inc.)
- Physical state: non coloured clear liquid
- Analytical purity: 99.98%
- Impurities (identity and concentrations): 2-methoxyethanol <20ppm; 2-ethoxyethanol <20ppm; ethylene glycol <20ppm; diethylene glycol <20ppm; ethylene oxyde <1ppm
- Lot/batch No.: Transcuto #l: 0025005 ; radiolabelled #: 104-272-053
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling): 98.2%
- Specific activity (if radiolabelling): 53mCi/mmol
- Locations of the label (if radiolabelling): 4- C
- Storage condition of test material: 0-5C
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley; BDIX
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO, L'Arbresle, France
- Age at study initiation: 7-8 weeks
- Weight at study initiation:
IV Route:
Sprague-Dawley: Male: 252+/-13g; Female: 228+/-8g
BDIX: Male: 253+/-4g
Oral Route:
Sprague-Dawley: Male 247+/-6g; Female 221+/-7g
BDIX: Male 233+/-10g; Female 180+/-7g
- Fasting period before study: overnight before administration and 4 hours following administration
- Housing: in makrolon cages furnished with stainless steel wire lids with catches
- Individual metabolism cages: yes, animals of the last group (168hr) ('techniplast', U.A.R. epinay sur Orge, France).
- Diet (e.g. ad libitum): ad libitum except during fasting period. Pellets (AO4C) supplied by U.A.R. (Epinay sur Orge, France).
- Water (e.g. ad libitum): ad libitum. Tap water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21C+/-2 (extreme temperature observed as 18-25C for short period of time)
- Humidity (%): 55+/-10% (extreme temperature observed as 25-90% for short period of time)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2001, June 27 To: 2001, November 6
Administration / exposure
- Route of administration:
- other: i.v. and oral
- Vehicle:
- other: saline for i.v. and water for oral
- Details on exposure:
- Syringe binding test: A syringe was filled up with the dosing solution and after agitation for 10 min, the dosing solution was transferred in another syringe and shaken again for 10 min. The radioactivity was measured before and after the 2 sequences of agitation in order to show any binding. This test was performed in triplicate. The difference between the two measurements did not exceed 10% which demonstrates the absence of significant binding.
PREPARATION OF DOSING SOLUTIONS:
For IV route: 20 mg of diethylene glycol monoethylether including 50 uCi (1.85MBq) of 14C-Diethylene glycol monoethylether was added in 1g of saline. Then the volume was completed to 2ml with saline.
For oral route: 20 mg of diethylene glycol monoethylether including 50 uCi (1.85MBq) of 14C-Diethylene glycol monoethylether was added in 1g of water. Then the volume was completed to 5ml with water.
In both cases the dosing solutions were not kept in contact with air for a long time to prevent any oxidation of the solutions.
Each day of administration the radioactivity content of the dosing solution was checked by HPLC. - Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20mg/kg (50uCi/kg) for both, i.v. (2ml/kg) and oral (5ml/kg) administrations
- No. of animals per sex per dose / concentration:
- See details under 'Any other information on materials and methods incl. tables'.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- See details under 'Any other information on materials and methods incl. tables'.
- Details on dosing and sampling:
- See details under 'Any other information on materials and methods incl. tables'.
- Statistics:
- Mean and standard variation.
Calculations were performed using Excel software directly from the raw data.
Results and discussion
- Preliminary studies:
- no data
Main ADME resultsopen allclose all
- Type:
- excretion
- Results:
- 85-90% within 24 hours post dose
- Type:
- absorption
- Results:
- absolute bioavailability 79-95%
- Type:
- distribution
- Results:
- Radioactivity in tissues significantly decreased at 48 hours
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- For intravenous route, the maximum plasmatic concentration of the radioactivity is observed 0.25 hours post dose and the plasmatic concentrations corresponded to about 32-35mg eq/kg
For oral route, the maximum plasmatic concentration of the radioactivity is observed 0.25- 0.50 hours post dose and the plasmatic concentrations corresponded to about 23-27mg eq/kg - Details on distribution in tissues:
- The tissue distribution of the radioactivity was characterised by high concentrations observed in hypophysis, thyroid, adrenals and bone marrow with regardsto the concentrations observed in blood/plasma (100 to 1000 times less ) at the same sampling time.
- Details on excretion:
- The radioactivity is rapidly excreted in urine whatever the sex and the route of administration (85-90% within 24 hours post dose)
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- Cmax: 32.22 and 34.58 mg.eq DIE/kg for male and female, respectively, i.v. route
- Test no.:
- #2
- Toxicokinetic parameters:
- Cmax: 23.34 and 26.63 mg.eq DIE/kg for male and female, respectively, oral route
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 84 and 48 hours for male and female, respectively, i.v. route
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 1st: 37 and 43 hours for male and female, respectively, oral route
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Table 1. Excretion recovery:
SD male rats |
|
i.v. Route |
Oral Route |
|
|
Mean±SD |
Mean±SD |
% in urine |
0-24hr |
89.04±1.26 |
85.50±3.47 |
% in urine |
0-168hr |
92.01±1.43 |
88.01±2.84 |
% in faeces |
0-24hr |
0.34±0.18 |
1.00±1.12 |
% in faeces |
0-168hr |
0.56±0.19 |
1.59±1.03 |
% in CO2 |
0-24hr |
0.37 |
0.42 |
% in CO2 |
0-168hr |
0.53 |
0.57 |
% in cage washing-water |
168hr |
0.91±0.58 |
0.98±0.48 |
% in carcass |
168hr |
2.78±0.72 |
1.71±0.41 |
RECOVERY (%) |
0-168hr |
96.26±1.80 |
92.83±1.03 |
|
|
|
|
SD female rats |
|
i.v. Route |
Oral Route |
|
|
Mean±SD |
Mean±SD |
% in urine |
0-24hr |
88.22±3.57 |
90.41±1.88 |
% in urine |
0-168hr |
90.78±2.57 |
93.33±2.17 |
% in faeces |
0-24hr |
0.66±0.37 |
0.35±0.12 |
% in faeces |
0-168hr |
0.76±0.33 |
0.50±0.10 |
% in CO2 |
0-24hr |
BLQ |
BLQ |
% in CO2 |
0-168hr |
BLQ |
BLQ |
% in cage washing-water |
168hr |
2.03±1.86 |
1.43±1.28 |
% in carcass |
168hr |
1.68±0.27 |
0.72±0.06 |
RECOVERY (%) |
0-168hr |
95.25±2.49 |
95.97±2.96 |
Table 2. Tissue distribution: Sprague-Dawley
0.5 h mg eq/kg |
Male |
Female |
Thyroid |
1.08 |
1.29 |
Hypophysis |
1.71 |
9.15 |
Adrenals |
0.34 |
0.25 |
Bone marrow |
0.22 |
0.41 |
Blood |
0.02 |
0.02 |
Plasma |
0.02 |
0.03 |
|
|
|
24 h mg eq/kg |
|
|
Thyroid |
0.08 |
BLQ |
Hypophysis |
BLQ |
BLQ |
Adrenals |
0.03 |
0.02 |
Bone marrow |
0.06 |
0.05 |
Blood |
0.0008 |
0.0005 |
Plasma |
0.0012 |
0.0008 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Not bioaccumulative. - Executive summary:
In a toxicokinetic study, 20 mg/kg of 14C radiolabelled 2 -(2 -ethoxyethoxy)ethanol was administered in male and female rats by oral and i.v. route. The absolute bioavailability of the radioactivity was 79 -95%. The Cmax corresponded to about 32 -35 mg eq/kg and 23 -27 mg eq/kg for i.v. and oral routes, respectively, at 0.25 and 0.25 -0.50 hrs post dose. With regards to concentrations in plasma, high concentrations were observed in hypophysis, thyroid, adrenals and bone marrow at the same sampling time. The plasmatic t1/2 corresponded to 37 to 84 hours and the radioactivity was rapidly excreted in urine whatever the sex and the route of administration (85% to 90% within 24 hours post dose). The test substance shows low bioaccumulation potential under the conditions of this study.
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