Registration Dossier
Registration Dossier
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EC number: 282-015-4 | CAS number: 84082-70-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Mentha piperita, Labiatae.
Basic toxicokinetics
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:
- 1 990
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
- Reference substance name:
- Peppermint oil
- IUPAC Name:
- Peppermint oil
- Details on test material:
- - Name of test material (as cited in study report): Peppermint oil
Constituent 1
- 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.
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