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EC number: 216-074-4 | CAS number: 1490-04-6
- 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
Menthol isomers were tested for skin irritation in rabbits according to the current OECD-guideline 404. All isomers were tested undiluted and in 50, 25, 5 and 1% concentrations. Diethylphthalate (DEP) was used as diluent. The investigations were performed in the same laboratories, using the same protocol.
Menthol in diethylphahtalate (DEP) was tested for eye irritation according to the current OECD-guideline 405.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
The undiluted compounds were irritating to the skin. Under the experimental conditions the mean score for erythema and edema was 3.
The test article formulation (menthol as 40% solution in DEP as vehicle) and the vehicle (DEP - dieethylphthalate) had almost the same eye-irritating potential. Menthol in a 40% solution is therefore not irritating to the eye.
According to the results from the skin irritation key-study a classification as Xi, R38 (erythema and edema socre: both 3) is justified. GHS: skin irrit. 2, H315).
For eye-irritation no classification required according DSD-DPD, according GHS due to the cornea score = 2.1 a classification as cat.2, H319 is adequate.
Other isomers and concentrations were also studied by the same testing laboratory.
A 29% solution of L-menthol had the following scores: cornea opacity 0.2; redness 0.6; chemnosis 0.1.
A 29% solution of D-menthol had the following scores: cornea opacity 0.4; redness 1.3; chemnosis 0.4.
(OECD SIDS for menthols, UNEP Publications).
Effects on skin irritation/corrosion: irritating
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Skin irritation:D/L-menthol meets the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008. Based on a valid key study performed according to OECD 404 protocol, the substance showed irritating properties with a maximum draize score of 3 that were reversible although not fully reversed at the highest concentration of 100% but the underlying skin remained intact. At concentrations below 50% menthol, the test data did not meet the criteria for classification as skin irritant. Consequently, a specific concentration limit for skin irritation Category 2 is set to ">25% by weight".
Eye irritation:According to CLP classification criteria, the substance meets the criteria for eye irritant category 2. However it does not need to be classified under Directive 67/548/EEC, as all scores were below the limits specified for eye irritation as set out in Directive 67/548/EEC.
Although 40% L-menthol in DEP when tested showed very slight irritation of the eye the results from testing 29% D- and L-menthol and 5% L-menthol clearly indicated no need for classification applying CLP criteria. Consequently, a specific concentration limit for eye irritation Category 2 is set to ">25% by weight".
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