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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Biotransformation of 12C- and 2-13C-Labeled Methyl tert-Butyl Ether, Ethyl tert-Butyl Ether, and tert-Butyl Alcohol in Rats: Identification of Metabolites in Urine by 13C Nuclear Magnetic Resonance and Gas Chromatography/Mass Spectrometry
Author:
Ulrike Bernauer
Year:
1998
Bibliographic source:
Chemical Research in Toxicology 1998, 11, 651-658

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
Rats were exposed to either tert-butyl alcohol at natural carbon isotope ratio or with 13C-enriched tert-butyl alcohol (250 mg/kg of body weight) to analyse the metabolism of tert-butyl alcohol. Urine was collected and the metabolites were identified by NMR and GC/MS.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): tert-butyl alcohol
- Analytical purity: 97 %
- Radiochemical purity (if radiolabelling): 97 %
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Weight at study initiation: 220-260 g
- Housing: single housing
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration and frequency of treatment / exposure:
once
Doses / concentrations
Remarks:
Doses / Concentrations:
250 mg/kg body weight
No. of animals per sex per dose / concentration:
3
Control animals:
no
Details on dosing and sampling:
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled (delete / add / specify): urine
- Time and frequency of sampling: for a time period of 72 hours
- From how many animals: (samples pooled or not) all 3 animals
- Method type(s) for identification: GC-MS, NMR

Results and discussion

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
tert-butyl alcohol, tert-butyl alcohol glucuronide, and tertbutyl alcohol sulfate, 2-hydroxyisobutyrate and 2-methyl-1,2-propanediol were identified as metabolites after treatment with tert-butyl alcohol.

Applicant's summary and conclusion