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Toxicological information

Basic toxicokinetics

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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:
2012
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
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.