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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study design and results were reported clearly and considered acceptable basic data

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Four male volunteers were administered 180 mg of Peppermint oil in an enteric-coated capsule following a 16 hours fasting period. Urine was collected every 2 hours for up to 14 hours, volume was measured. Menthol and menthol glucuronide concentrations were determined in urine by gas chromatography using an enzme-sensitive internal standard and flame ionization detection..
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Peppermint oil
IUPAC Name:
Peppermint oil
Details on test material:
- Name of test material (as cited in study report): Peppermint oil
Radiolabelling:
no

Test animals

Species:
human
Strain:
other: N/A
Sex:
male
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: capsule
Vehicle:
unchanged (no vehicle)
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
180 mg of Peppermint oil was administered in an enteric-coated capsule.
Duration and frequency of treatment / exposure:
One time administration
Doses / concentrations
Remarks:
Doses / Concentrations:
180 mg peppermint oil
No. of animals per sex per dose / concentration:
4 male volunteers
Control animals:
no
Positive control reference chemical:
Not included
Details on study design:
- Dose selection rationale: No data
Details on dosing and sampling:
PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine
- Time and frequency of sampling: every 2 hours after administration for up to 14 hours
Statistics:
Not performed

Results and discussion

Preliminary studies:
Not performed
Main ADME results
Type:
excretion
Results:
Between 37 and 116 mg menthol recovered in urine within 14 hours of administration of Peppermint oil

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not studied
Details on distribution in tissues:
Not studied
Details on excretion:
A significant amount of variation among each individual was observed in the urinary excretion profile over 14 hours (see attached illustration/graph). AUC analysis indicated that 37-116 mg of menthol was excreted. As no concentration of menthol in the administered peppermint oil was determined, it is not possible to calculate the percentage of recovery.

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
Menthol glucuronide is determined in urine (metabolite of menthol), which indicates the amount of Peppermint oil that is orally absorbed.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: oral absorption and urinary excretion apparent
Under the condtions of this study, menthol was recovered in urine after peppermint oil administration. However, no percentage of recovery could be calculated as the menthol concentration in the administered peppermint oil was not determined.
Executive summary:

Four male volunteers were administered 180 mg of Peppermint oil in an enteric-coated capsule following a 16 hours fasting period. Urine was collected every 2 hours for up to 14 hours, volume was measured and analysed by gas chromatography.

A significant amount of variation among each individual was observed in the urinary excretion profile over 14 hours. AUC analysis indicated that 37-116 mg of menthol was excreted. As the menthol concentration in the administered peppermint oil was not determined, no percentage of recovery could be determined.