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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
Carcinogenicity
Administrative data
Description of key information
A bioassay of dl-menthol for possible carcinogenicity was conducted by administrating the test chemical in feed to Fisher 344 rats and B6C3F1 mice.
No carcinogenic effects were observed at the highest applied doses.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented and scientifically acceptable
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- A bioassay of dl-menthol for possible carcinogenicity was conducted by administrating the test chemical in feed to Fisher 344 rats.
Groups of 50 rats of each sex were administrated dl-menthol at one of the following doses, either 3750 or 7500 ppm for 103 weeks, then observed for 1 or 2 additional weeks. Matched controls consisted of 50 untreated rats of each sex. All surviving rats were killed at 105 weeks. - GLP compliance:
- not specified
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2 batches test:
Lot No. 4-HTP-6
Lot No. Nl 1-26-74-2054
Identity confirmed
Batch 1:
2 impurites:
0.3 %
1.3 %
Batch 2:
0.2 % Impurity
OTHER SPECIFICS: USP-grade - Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- diet
- Duration of treatment / exposure:
- 103 w
- Frequency of treatment:
- daily
- Post exposure period:
- 1 -2 weeks
- Remarks:
- Doses / Concentrations:
3750 or 7500 ppm (= ca. 188 or 375 mg/kg bw/d)
Basis: - No. of animals per sex per dose:
- 50 rats of either sex/dose
- Control animals:
- other: untreated diet containing 2 % corn oil
- Details on study design:
- Post-exposure period: 2 w
- Relevance of carcinogenic effects / potential:
- dl-menthol was not carcinogenic under the test conditions used
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 375 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no carcinogenic effect at any dose
- Remarks on result:
- other: Effect type: carcinogenicity
- Executive summary:
A bioassay of dl-menthol for possible carcinogenicity was conducted by administrating the test chemical in feed to Fisher 344 rats.
Groups of 50 rats of each sex were administrated dl-menthol at one of the following doses, either 3750 or 7500 ppm for 103 weeks, then observed for 1 or 2 additional weeks. Matched controls consisted of 50 untreated rats of each sex. All surviving rats were killed at 105 weeks.
In male rats, no tumors occured at incidences which were considered to be related to the administration of dl-menthol.
In female rats, no tumors occured at higher incidences in the dosed groups than in the control groups. Fibroadenomas of the mammary gland occured at lower incidences in the low dose (10/49) and high-dose (7/49) groups than in the control group (20/50), and alveolar/bronchiolar adenomas or carcinomas of the lung occured only in the controls (3/50).
There was no evidence of carcinogenicity of D/L-menthol in rats and mice in a study performed in accordance with current standards (highest tested dose levels in rats approx. 375 mg/kg bw). Since D/L-menthol contains the two relevant isomers in a 50:50 ratio it can be assumed that also L- and D-menthol have no carcinogenic properties.
Reference
Mean body weights of dosed rats were only slightly lower than those of corresponding controls. No other clinical signs related to administration of the dl-menthol were noted in the dosed groups of animals. Survival at the end of the bioassay was at least 62% in all dosed and control groups of animals and sufficient numbers of animals were at risk for the development of late-appearing tumors.
In both dose groups no increased incidence of neoplasms compared to the controls were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 375 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- scientifically acceptable and well documented.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
From the available studies a classification according to CLP classification criteria (Regulation (EC) No 1272/2008) is not justified.
Additional information
In male and female rats the survival rate was not affected by treatment and no carcinogenic effects of D/L-menthol were found in any organ.
In mice of either sex, no tumors occurred in dosed groups at incidences that were significantly different from those for corresponding control groups.
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