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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.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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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