Registration Dossier
Registration Dossier
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EC number: 259-370-9 | CAS number: 54839-24-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Modern GLP study with original study report available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- To establish the rate of hydrolysis of the ester to the constituent glycol ether ethoxypropanol in vitro.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethoxy-1-methylethyl acetate
- EC Number:
- 259-370-9
- EC Name:
- 2-ethoxy-1-methylethyl acetate
- Cas Number:
- 54839-24-6
- Molecular formula:
- C7H14O3
- IUPAC Name:
- 2-ethoxy-1-methylethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): ethoxypropyl acetate
- Physical state: liquid
- Analytical purity: 99.76% (sum of isomers)
- Lot/batch No.:11AC0007-L2
- Expiry date 31/12/12
- Stability under test conditions: stable.
- Storage condition of test material: room temperature in the dark.
- Other:
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
Results and discussion
- Preliminary studies:
- The linearity of the detector response in rat plasma with respect to concentration was assessed over the nominal concentration range of 0 to 100 mg/L. This was satisfactory with a correlation coefficient (r) of 0.9997 being obtained.
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parameters
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 48 mins (SD=7)
Any other information on results incl. tables
Summary of results
Nominal Concentration (mM) |
Test 1 (minutes) |
Test 2 (minutes) |
Test 3 (minutes) |
Mean Half-Life (minutes) |
38 |
55.7 |
40.1 |
81.3 |
59.1 |
380 |
54.7 |
49.3 |
40.7 |
48.2 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
- Executive summary:
An in vitro study established that the half life of ethoxypropyl acetate hydrolysis to ethoxypropanol in rat plasma is around 48 mins (SD=7). This study confirms the suitability of using ethoxpropanol as a surrogate to predict in vivo systemic toxicity of ethoxypropyl acetate.
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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