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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
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Dose No.: B244
Author:
RSC Publishing
Year:
2011
Bibliographic source:
Dictionary of Substances and their effects (DOSE):Furia, T. E. (Ed.) CRC Handbook of Food Additives 2nd ed., 1972, Chemical Rubber Co., Cleveland, OH.
Reference Type:
other: Authoritative data base
Title:
NTP study for 25013-16-5
Author:
NTP Database
Year:
2012
Bibliographic source:
NTP (National Toxicological Program)by Agency for Toxic Substances and Disease Registry; Division of Toxicology/Toxicology Information Branch, 1600 Clifton Road NE, E-29, Atlanta, Georgia 30333

Materials and methods

Objective of study:
excretion
Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from NTP database
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl-4-methoxyphenol
EC Number:
246-563-8
EC Name:
tert-butyl-4-methoxyphenol
Cas Number:
25013-16-5
Molecular formula:
C11H16O2
IUPAC Name:
(1,1-Dimethylethyl)-4-methoxyphenol
Details on test material:
- Name of test material (as cited in study report): tert-butyl-4-methoxyphenol
- Substance type: Organic
- Physical state: Solid
Radiolabelling:
not specified

Test animals

Species:
human
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses / concentrations
Remarks:
Doses / Concentrations:
50 mg of tert-butyl-4-methoxyphenol (BHA)
Control animals:
not specified

Results and discussion

Main ADME results
Type:
excretion
Results:
27-77% was excreted in the urine

Toxicokinetic / pharmacokinetic studies

Details on excretion:
27-77% was excreted in the urine as the glucuronide and urinary metabolites.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
glucuronide and urinary metabolites.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
When male human volunteers were given an oral dose of 50 mg tert-butyl-4-methoxyphenol (BHA), 27-77% was excreted in the urine as the glucuronide and urinary metabolites.
Executive summary:

When male human volunteers were given an oral dose of 50 mg tert-butyl-4-methoxyphenol (BHA), 27-77% was excreted in the urine as the glucuronide and urinary metabolites.