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EC number: 218-690-9 | CAS number: 2216-51-5
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 375 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Additional information
There is no reproductive toxicity data on L Menthol.
Justification for Read-across:
Based on the identical profiles of the different Menthols we can use them for read across studies as described in the Read-Across Justification for Menthols (see file MentholsReadAcrossFinal.pdf in section 13). These isomers are L Menthol (CAS 2216-51-5), D Menthol (CAS 15356-60-2) and DL Menthol (CAS 89-78-1).
Moreover, a comparative physico-chemical profile of these isomers reinforces this similarity. As structural isomers, the members of the Menthol category share the same molecular weight. Of particular importance to environmental effects and human effects are the values for partition coefficient (log Kow around 3), vapour pressure (from 17 Pa at 25 °C for the DL Menthol to 21 Pa 25 °C for the natural L Menthol ) and water solubility (moderately soluble from 410 mg/l at 25 °C for the natural L Menthol to 470 mg/l at 25 °C for the DL Menthol). The read across is consistent based on these physico-chemical parameters.
In OECD SIDS, L Menthol (CAS 2216-51-5), D Menthol (CAS 15356-60-2) and DL Menthol (CAS 89-78-1) were recognized as a category group. Investigations on toxicokinetics show that L-, D-, DL- and the unspecified Menthol are well absorbed via the oral route. For all of the isomers, elimination is rapid and mainly occurs as glucuronic acid conjugates via urine, minor amounts via faeces. Significant differences in toxicokinetic properties of Menthol isomers were not reported.
The available toxicity data indicate very similar toxicity profiles for D-, L-, DL Menthol and the unspecified Menthol isomer mixture. In mammalian species the low toxicity is manifested in LD50 values generally greater than 2000 mg/kg bw/day in acute studies, limited toxicity in repeated dose studies, and no effects in teratology evaluations. Irritation to skin and eyes was slight to moderate. DL-Menthol is a racemic mixture of the D- and L- isomers and contains both isomers in equal proportion. Data gaps for L Menthol can therefore be filled by the respective results with the racemic mixture or the D Menthol isomer.
Due to above discussion, to this endpoint, reproductive properties of L Menthol can be thought equivalent to the tested substance DL Menthol (The NOAEL in this study on rats was determined at 375 mg/kg bw/day).
Detail for the waiving approach:
Since histopathological examinations of the reproduction organs of rats and mice did not show any changes in repeated dose toxicity studies of DL Menthol and also in carcinogenicity studies of DL Menthol, we can anticipate the same conclusion for L Menthol.
Short description of key information:
No changes were observed during the histopathological examinations of the reproductive organs of rats and mice in repeated dose toxicity studies and in carcinogenicity studies following the exposure to the Menthol isomer mixture: DL Menthol.
Toxicity to reproduction does not need to be conducted.
Effects on developmental toxicity
Description of key information
L Menthol is not considered to be embryo-or fetotoxic or teratogenic.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- rat
Additional information
Justification for classification or non-classification
No changes were observed during the histopathological examinations of the reproductive organs of rats and mice in the combined repeated dose and 2 years carcinogenicity toxicity studies following exposure to the Menthol isomer mixture: DL Menthol.
The L Menthol has no developmental toxicity and no teratogenicty properties in well performed gavage studies in various species (rat, mouse, rabbit, hamster) at the highest dose of 185 (for mice) to 425 (for rabbits) mg/kg bw. Since we could only derived a NOEL for these 4 species we can consider that the L Menthol has no developmental or teratogenicity hazard.
The L Menthol should therefore not be classified either on reproduction toxicity or teratogenicity.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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