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EC number: 201-159-0 | CAS number: 78-93-3
Basic toxicokinetics
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:
- 1 976
- 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
- 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
Constituent 1
- 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.
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