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EC number: 201-939-0 | CAS number: 89-78-1
- 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
Description of key information
The studies on acute oral toxicity were not performed according to
guideline methods. However, the number of treated animals and the used
protocols are scientifically acceptable to evaluate this endpoint
sufficiently.
A valid study on acute inhalation toxicity according OECD TG 403 was
conducted.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: sufficient documented for evaluation
- Principles of method if other than guideline:
- Groups of 10 young adult Osborne-Medel rats were given menthol by intubation. Animals were observed for 2 weeks during which time the development of toxic signs were followed and time of death noted. The acute oral LD50 was determined.
- GLP compliance:
- no
- Test type:
- standard acute method
- Specific details on test material used for the study:
- OTHER SPECIFICS: Menthol (p-menthan-3-ol)
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- no data
- No. of animals per sex per dose:
- 5 males + 5 females/group
- Control animals:
- not specified
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 3 180 mg/kg bw
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was 3180 mg/kg bw (rat, male/female)
- Executive summary:
Groups of 10 young adult Osborne-Medel rats were given menthol by intubation. Animals were observed for 2 weeks during which time the development of toxic signs were followed and time of death noted.
The acute oral LD50 was 3180 mg/kg bw (rat, male/female)
Reference
toxic signs: ataxia, scrawny appearance
death time: 4 hr - 3 days
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 180 mg/kg bw
- Quality of whole database:
- Sufficient documented for evaluation.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Two groups of 5 male and female rats each were nose-only at actual aerosol concentration of 4225 and 5038 mg/m³. The aerosol was generated neat without any vehicle (aerosolization of the molten crystalline, solid substance above the melting point). The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: CHHYDN0130
- Purity: D-Menthol 50.6%
L-Menthol 49.4%
Nonvolatile residue: 0.01%
Water: 0.01%
FORM AS APPLIED IN THE TEST
White crystalline solid
OTHER SPECIFICS:
Characterization of chamber atmosphere - Mean values
Group 1 Group 2 Group 3
Target Conc. (mg/m³) 0 4500 5000
Gravimetric Conc. (mg/m³) -- 4225 5037.5
Cascade Impactor:
MMAD (μm) -- 3.16 3.07
GSD 1.63 1.97
Mass <3 μm (%) 46.0 50.1 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0, 4225, or 5038 mg/m³
- No. of animals per sex per dose:
- 5 male and 5 female animals per dose
- Control animals:
- yes
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 5 289 mg/m³ air
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Remarks on result:
- other: LC50 inhalation aerosol
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A study on the acute inhalation toxicity of DL-Menthol on rats has been conducted in accordance with OECD TG#403 (2009). Two groups of rats were exposed nose-only at actual aerosol concentration of 4225 and 5038 mg/m³. The aerosol was generated neat without any vehicle (aerosolization of the molten crystalline, solid substance above the melting point).
The results can be summarized as follows:
LC50 (inhalation aerosol, 4 h) Approximate LC50-males&females: 5289 mg/m³.
NO(A)EL Males&females: <4225 mg/m³
The following clinical signs were observed: bradypnea, labored breathing pattern, dyspnea, motility reduced, atony, tremor, high-legged gait, staggering gait, movements uncoordinated, piloerection, haircoat ungroomed, nasal discharge (serous), nose and/or muzzle: red encrustations, nostrils: red encrustations, stridor, breathing sounds, apathy, narcosis, prostration, miosis, hypothermia, decreased reflexes, and transient decrease in body weights. The lead pathodiagnostic effects were suggestive of a narcotic condition associated with increased airway secretions/mucous membrane irritation. Consistent with this mode of action, mortality occurred at 5038 mg/m³ during the course of the exposure period. CNS-related effects were rapidly reversible. Bradypnea and labored breathing patterns were observed up to postexposure day 10.
The respirability of the aerosol was adequate to achieve the objective of study, i.e. the average mass median aerodynamic diameter (MMAD) was 3.1 μm, the average geometric standard deviation (GSD) was 1.8.
The aerosolized test substance proved to have a low acute inhalation toxicity in rats and a classification is not justified.
Reference
Summary of acute inhalation toxicity - 4 hour exposure - Mean values
NGroup /sex Target Concentration (mg/m³) Toxicological Result Onset and Duration of Signs Onset of Mortality
1 / m 0 0 / 0 / 5 -- --
2 / m 4500 0 / 5 / 5 0d– 10d --
3 / m 5000 2 / 1 / 3 0d – 14d 3h
1 / f 0 0 / 0 / 5 -- --
2 / f 4500 0 / 5 / 5 0d – 8d --
3 / f 5000 1 / 2 / 3 0d – 8d 2h
N = group assignment, m = males, f = females, animals found dead 2-3h after onset of exposure (0h-
3h), * = p < 0.05, ** = p < 0.01.
Values given in the 'Toxicological results' column are: 1st = number of dead animals, 2nd = number of
animals with signs after cessation of exposure, 3rd = number of animals exposed.
Necropsy
The qualitative description given below focuses on key-findings only.
Animals succumbing during the observation period: The most salient findings are characterized by colorless discharge from nose and a viscous, white content in the nostrils; less collapsed lung; stomach: bloated; small intestine: reddened mucosa and red mucous content; parenchymatous organs: pallor.
Animals sacrificed at the end of the observation period: The macroscopic findings in surviving rats were essentially indistinguishable from the control.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 289 mg/m³ air
- Quality of whole database:
- GLP guideline study.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Data from a secondary source showed a LD50 > 5000 mg/kg bw for acute dermal toxicity.
Additional information
Studies on rats and mice showed acute oral toxicity with LD50 values higher than 2000 mg/kg bw with one exception where a value of 940 mg/kg bw was found in an insufficient documented mutagenic evaluation study.
In the acute inhalation toxicity study on rats a LC50 (aerosol, 4h) = 5289 mg/m³ was determined.
Data from a secondary source showed a LD50 > 5000 mg/kg bw for acute dermal toxicity.
Justification for classification or non-classification
In the reliable acute oral toxicity study demonstrated a low systemic toxicity with a LD50 higher than 2000 mg/kg bw.
In the acute inhalation study a LC50 > 5000 mg/m³ was (rat, aerosol, 4 h) was determined.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
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