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Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study

Data source

Reference
Reference Type:
publication
Title:
Characterization of the metabolites of methyl n-butyl ketone, methyl iso-butyl ketone, and methyl ethyl ketone in guinea pig serum and their clearance.
Author:
DiVincenzo GD, Kaplan CJ, Dedinas J
Year:
1976
Bibliographic source:
Toxicol Appl Pharmacol 36: 511-522

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
- Principle of test: characterisation of metabolites.
- Short description of test conditions: A single dose of test substance was administered by intraperitoneal injection.
- Parameters analysed / observed: Metabolites in serum were identified and quantified by GS and GS-MS. The fates of several of the metabolites was investigated. Serum half-lives and clearance times were calculated.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butanone
EC Number:
201-159-0
EC Name:
Butanone
Cas Number:
78-93-3
Molecular formula:
C4H8O
IUPAC Name:
butan-2-one
Specific details on test material used for the study:
Name: methyl ethyl ketone (MEK)
Purity: >98%
Source: Eastman Organic Chemicals, Rochester, New York USA
Impurities: contained traces of 2-butanol
Radiolabelling:
no

Test animals

Species:
guinea pig
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 250-450 g
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
corn oil
Duration and frequency of treatment / exposure:
A single dose was administered
Doses / concentrations
Dose / conc.:
450 mg/kg bw/day (nominal)
No. of animals per sex per dose / concentration:
Four
Details on dosing and sampling:
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: blood
- Time and frequency of sampling: 1,2,4,6,8,12 and 16 hours after dosing
- Method type(s) for identification: GC-MS; NMR
- Limits of detection and quantification: No information

Results and discussion

Main ADME results
Type:
metabolism
Results:
Metabolites identified: 2-butanol, 3-hydroxy-2-butanone, 2.3-butanediol

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Test no.:
#1
Toxicokinetic parameters:
half-life 1st: Serum half-life: 270 minutes
Test no.:
#1
Toxicokinetic parameters:
C(time): of test substance
Remarks:
6 hours
Test no.:
#1
Toxicokinetic parameters:
C(time): of all metabolites
Remarks:
16 hours

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Metabolites identified: 2-butanol, 3-hydroxy-2-butanone, 2.3-butanediol

Applicant's summary and conclusion

Conclusions:
In a study in which methyl ethyl ketone (MEK) was administered to four male guinea pigs by intraperitoneal injection, 3-hydroxy-2-butanone and 2,3-butanediol were identified as the primary metabolites in serum. A small proportion was converted to 2-butanol (sec-butyl alcohol, sBA). A metabolic pathway was proposed.