2-(2-butoxyethoxy)ethyl acetate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vitro / ex 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: Rationale for reliability A published study but one which contains sufficient experimental detail to be able to judge it reliable for risk 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:

1989

Bibliographic source:

Xenobiotica, 19, 9, 981-9

Materials and methods

Objective of study:

metabolism

Principles of method if other than guideline:

To establish the rate of in vitro enzymic hydrolysis in the blood of rats of the substance to the parent glycol ether 2-(2-butoxyethoxy)ethanol.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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)

Radiolabelling:

yes

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
- Water: ad libitum

Results and discussion

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parameters

Toxicokinetic parameters:

half-life 1st: 3 minutes

Any other information on results incl. tables

Metabolism of the substance in blood through hydrolysis to 2 -(2 -butoxyethoxy)ethanol (22BEE) was rapid. By 12 minutes the concentration of the 2 -(2 -butoxyethoxy)ethyl acetate was reduced by a mean of 94% to 0.2mM where it reached a plateau. Similarly the concentration of the metabolite 22BEE rose rapidly to a plateau of 4.1mM. No hydrolysis was seen in saline solution and no significant decrease in 22BEE concentration was seen when this was incubated in either blood or saline.

Applicant's summary and conclusion

Conclusions:

The hydrolysis of 2-(2-butoxyethoxy)ethyl acetate to the parent glycol ether 2-(2-butoxyethoxy)ethanol in blood is very rapid. This suggests that
data for the latter is likely to be a very good surrogate for the systemic toxicity of the former.

Executive summary:

In an in vitro study to establish the rate of in vitro metabolism of 2 -(2 -butoxyethoxy)ethyl acetate in the blood of rats to the parent glycol ether 2-(2-butoxyethoxy)ethanol, hydrolysis was found to be very rapid with a half life of approximately 3 minutes. This suggests that data for the latter is likely to be a very good surrogate for the systemic toxicity of the former.