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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
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The distribution of 14Cp-ter.-butyltoluene (TBT) following inhalation by the rat: A whole body autoradiographic study.
Author:
Ingebrigtsen K and Walde A
Year:
1982
Bibliographic source:
Acta pharmacol et toxicol 51: 203-208.
Reference Type:
publication
Title:
Metabolism of p-tert.-Butyltoluene in the Rat and Guinea Pig.
Author:
Walde A and Scheline RR
Year:
1983
Bibliographic source:
Acta Pharmacol Toxicol 53: 57-63.

Materials and methods

Objective of study:
excretion
Principles of method if other than guideline:
Method: other
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butyltoluene
EC Number:
202-675-9
EC Name:
4-tert-butyltoluene
Cas Number:
98-51-1
Molecular formula:
C11H16
IUPAC Name:
1-tert-butyl-4-methylbenzene
Details on test material:
(methyl-14C)p-tert-butyltoluene; according to the authors, radiochemical purity was 98-99%; no further data
Radiolabelling:
yes
Remarks:
14C

Test animals

Species:
other: rat, guinea pig
Strain:
other: Wistar (rat), Dunin Hartley (guinea pig)
Sex:
male

Administration / exposure

Route of administration:
other: intragastric, inhalation
Vehicle:
not specified
Doses / concentrations
Remarks:
Doses / Concentrations:
100 mg/kg bw

Results and discussion

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Toxicokinetic parameters:
half-life 2nd:
Toxicokinetic parameters:
half-life 1st:
Toxicokinetic parameters:
half-life 3rd:

Any other information on results incl. tables

The elimination of the test substance after intragastric and inhalational administration (doses of 100 mg/kg) was studied in male Wistar rats and in male Dunkin Hartley guinea pigs.

The test substance was well absorbed through the gastro-intestinal and respiratory tract, was quickly distributed, and was eliminated within a few days.

In rats, 73% of a single oral dose (100 mg/kg) was recovered in the urine and feces within 3 days. After 10 days, 83% of the administered dose was recovered; the ratio of urinary/fecal radioactivity was ca. 3.5 : 1. Elimination was biphasic with the slower elimination phase beginning on day 6 after dosing.

At day 3 after dosing, urinary excretion of radioactivity was 45% and 25% after oral and inhalational exposure, respectively, in rats and 42% and 41% after oral and inhalational administration, respectively, in guinea pigs.

Applicant's summary and conclusion