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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

Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Background
Peppermint oil is a substance of
Unknown or Variable composition, Complex reaction products or Biological
material (UVCB substances), or more specifically an NCS (Natural Complex
Substance). As such, peppermint oil is part of the particular category
of essential oils, extracts, fractions and distillation products of the
mint species of chapter 1.2, which are all variants of the botanical
Lamiaceae family, genus Mentha. A justification for read across within
this category can be found in the “Reporting format for Natural Complex
Substances of the Mint essential oils of the Lamiaceae family, genus
Mentha”. The other member of this category is cornmint oil. The category
is based on the part of the plant from which the NCSs are produced
(fresh, above ground parts of the flowering plants), the common methods
of production, the same dominant constituent (L-menthol and Menthone (in
combination >60%)), and the same and/or similar constituents. Several
publications concerning the toxicokinetics of peppermint oil are
available in the dossier. Furthermore, the physical/chemical parameters
of the constituents will be taken into account.
Information from experimental studies
The toxicokinetics properties of
peppermint oil were examined in several in vivo human studies, as well
as in vitro studies with human liver microsomes. In the in vivo studies,
human volunteers were exposed to different forms of delayed-release
capsules containing peppermint oil, for its use to treat irritable
bowel/spastic colon syndrome. The excretion of menthol in the urine was
measured after a single dose of peppermint oil to human volunteers in
three different experiments. Results show a recovery of 35-40% in urine
as menthol or mentholglucuronide after 24hr (Somerville et al., 1984),
while in another experiment 87-112% was recovered as menthol or
mentholglucuronide in urine (White, 1987). In the third study menthol
was also determined in urine, however, percentage recovery could not be
determined (Kaffenberger, 1990). These studies indicate that peppermint
oil is absorbed after oral exposure. In vitro and in vivo experiments
examining effects of peppermint oil on the metabolism of two different
calcium channel blockers (nifedipine and felodipine), show that
peppermint oil is a reversible, partially mixed inhibitor of metabolism
of these substances both in vitro and in vivo, indicating inhibition of
CYP3A4. (Dresser et al., 2002) This study indicates that metabolism of
peppermint oil is expected in the human body. No information could be
retrieved concerning dermal and inhalation absorption.
Physical/chemical properties of
constituents
Physical/chemical parameters
indicating whether absorption via the oral, inhalation and dermal route
is expected, are for example molecular weight, water solubility, log
Kow, and vapour pressure. Please find below a table containing these
parameters for the constituents of peppermint oil.
Constituent |
Molecular weight |
Water solubility (mg/l at 25°C) |
Log Kow |
Vapour pressure (Pa at 25°C) |
L-menthol |
156.27 |
941.74 |
3.38 |
1.02 |
Menthone |
154.25 |
895.86 |
2.87 |
49.4 |
L-limonene |
136.24 |
44.388 |
4.83 |
193 |
betapinene |
136.24 |
2.6192 |
4.35 |
334 |
1,8-cineole |
154.25 |
551.66 |
3.13 |
208 |
Alpha-Pinene |
136.24 |
3.4834 |
4.27 |
536 |
Iso-menthone |
154.25 |
895.86 |
2.87 |
49.4 |
neo-menthol |
156.27 |
941.74 |
3.38 |
1.02 |
Methyl acetate |
198.31 |
53.781 |
4.39 |
12.2 |
Piperitone |
152.24 |
135.01 |
3.07 |
13.8 |
Pulegone |
152.24 |
212.83 |
3.2 |
21.6 |
Iso-Pulegol |
154.25 |
943.2 |
3.37 |
0.662 |
Germacrene-D |
204.36 |
0.81945 |
6.99 |
3.04 |
Neo-iso-pulgol |
154.25 |
943.2 |
3.37 |
0.662 |
Octan-3-ol |
130.23 |
1285.3 |
2.73 |
13.3 |
Sabinene |
136.24 |
2.6192 |
4.69 |
981 |
Myrcene |
136.24 |
17.814 |
4.88 |
320 |
Neo-iso-menthol |
156.27 |
941.74 |
3.38 |
1.02 |
Beta-caryophyllene |
204.36 |
0.54268 |
6.3 |
4.16 |
Menthofuran |
150.22 |
47.144 |
4.29 |
10.7 |
trans sabinene hydrate |
154,25 |
742,39 |
3,19 |
13,2 |
cis-Ocimene |
136,24 |
38,089 |
4,8 |
358 |
Gamma-terpinene |
136,24 |
59,034 |
4,75 |
153 |
Terpinolene |
136,24 |
93,066 |
4,88 |
133 |
Although, based on vapour pressure, most
constituents have a low volatility (<0.5 KPa), exposure via inhalation
is included based on the use of peppermint oil as a fragrance. Oral
absorption and absorption via inhalation is expected for most
substances, as they have a molecular weight <500, moderate to high water
solubility, and log Kow between 1-4. Substances with a log Kow>4 and
with a low water solubility, such as betapinene, alpha-pinene,
germacrene-D, sabinene, beta-caryophyllene, may be less well absorbed
orally due to their log Kow >4 and relatively low water solubility.
Dermal absorption is not favoured based on the molecular weights of the
substances, neither can it be ruled out. For the substances which have a
log Kow <4 combined with a relatively high water solubility, dermal
absorption is expected. For betapinene, alpha-pinene, germacrene-D,
sabinene, beta-caryophyllene, which have a log Kow >4 and relatively low
water solubility, dermal absorption is expected to be low to moderate.
Conclusion
Toxicokinetic studies with
peppermint oil indicate that the substance is orally absorbed and
metabolized. Based on physical properties of the constituents,
absorption via the oral, inhalation and dermal route is expected to be
moderate to high. For risk assessment, a default absorption of 100% is
assumed.
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