Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The documentation is from secondary literature.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
basic toxicokinetics
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The documentation is from secondary literature.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 417 (Toxicokinetics)
Principles of method if other than guideline:
The metabolism of p-tert-butyltoluene (TBT) was studied in the rat and guinea pig.
GLP compliance:
not specified
Radiolabelling:
not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
not specified
Control animals:
no
Metabolites identified:
yes
Details on metabolites:
The major urinary metabolites in rats were p-tert-butylbenzoic acid and its alcohol derivative 2-(p-carboxyphenyl)-2-methylpropan-1-ol whereas p-tert-butylbenzoylglycine was the most prominent metabolite in guinea pig urine.
Conclusions:
Interpretation of results: low bioaccumulation potential based on study results
Executive summary:

The metabolism of p-tert-butyltoluene (TBT) was studied in the rat and guinea pig. Both the methyl and the tert.-butyl group were oxidized to alcohol and carboxylic acid derivatives in these species. The major urinary metabolites in rats were p-tert-butylbenzoic acid and its alcohol derivative 2-(p-carboxyphenyl)-2-methylpropan-1-ol whereas p-tert-butylbenzoylglycine was the most prominent metabolite in guinea pig urine. No significant differences in metabolism were found when TBT was given intragastrically or by inhalation. The intragastric administration of 14C-TBT to rats showed that the bulk of the excretion of radioactivity occurred within three days. A recovery of 83% was achieved and the ratio of urinary/faecal radioactivity was roughly 3.5:1.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C10, aromatics, >1% naphthalene
EC Number:
919-284-0
Cas Number:
Not applicable
Molecular formula:
None available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C10, aromatics, >1% naphthalene
Test material form:
liquid
Details on test material:
Name of substance: Hydrocarbons, C10, aromatics, >1% naphthalene
EC# 919-284-0

Results and discussion

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
The major urinary metabolites in rats were p-tert-butylbenzoic acid and its alcohol derivative 2-(p-carboxyphenyl)-2-methylpropan-1-ol whereas p-tert-butylbenzoylglycine was the most prominent metabolite in guinea pig urine.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: low bioaccumulation potential based on study results
Executive summary:

This data is being read across from the source study that tested 1-tert-butyl-4-methylbenzene based on analogue read across.

The metabolism of p-tert-butyltoluene (TBT) was studied in the rat and guinea pig. Both the methyl and the tert.-butyl group were oxidized to alcohol and carboxylic acid derivatives in these species. The major urinary metabolites in rats were p-tert-butylbenzoic acid and its alcohol derivative 2-(p-carboxyphenyl)-2-methylpropan-1-ol whereas p-tert-butylbenzoylglycine was the most prominent metabolite in guinea pig urine. No significant differences in metabolism were found when TBT was given intragastrically or by inhalation. The intragastric administration of 14C-TBT to rats showed that the bulk of the excretion of radioactivity occurred within three days. A recovery of 83% was achieved and the ratio of urinary/faecal radioactivity was roughly 3.5:1.