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EC number: 222-824-1 | CAS number: 3623-51-6
- 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
No data is available for (±)-neomenthol. Reliable data are available from L-menthol.
L-menthol and thus (±)-neomenthol is not skin sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to IUCLID section 13 for a detailed justification of the category approach.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no reaction
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no reaction
- Remarks on result:
- no indication of skin sensitisation
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 1% w/v
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 10% w/v
- Parameter:
- SI
- Value:
- 0.91
- Test group / Remarks:
- 30% w/v
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 1% w/v : Counts per minute (cpm)=1212 10% no effects : Counts per minute (cpm)=2234 30% no effects : Counts per minute (cpm)=1131
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance is not considered to be a skin sentizer as observed in the LLNA and Buehler tests in guinea pigs.
- Executive summary:
A LLNA test and a Buehler test are available from structural analogue L-menthol (CAS 2216 -51 -5). It is concluded that (±)-neomenthol is not skin sensitising. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the skin sensitising potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no reliable skin sensitisation study on (±)-neomenthol available.
Justification for Read-across:
Based on the identical profiles of the different menthols and supported by the Read-Across Justification for menthols (IUCLID chapter 13) all studies on stereoisomers of (±)-neomenthol are used for read across. These isomers are L-menthol (CAS 2216-51-5), (+)-menthol (CAS 15356-60-2), D/L-menthol (CAS 1490 -04 -6) and 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 Pow between 3.12 and 3.45 at 25°C), vapour pressure (from 3.6 to 21 Pa at 25°C) and water solubility (moderately soluble from 231 to 456 mg/L at 25°C). The read across is consistent based on these physico-chemical parameters.
Details on skin sensitising potential of L-menthol:
An LLNA study according to OECD 429 was performed with L-menthol (1995). L-menthol at concentrations of 1, 10 and 30% w/v was tested. The increase in isotope incorporation was less than 3-fold at all concentrations. Also the response was not consistent with a biological dose-response. The SI values were 1.3, 1.8 and 0.91 at 1, 10 and 30% L-menthol concentrations, respectively. Consequently, L-menthol is not a skin sensitiser.
A Buehler test (according to OECD 406) was performed with L-menthol (1991). Following dose ranging a concentration of 25% w/v in ethanol : DEP was selected for induction and challenge. At challenge, none of the test and control animals treated with L-menthol at a concentration of 25% w/v in ethanol : DEP showed a positive response. Consequently, there is no evidence from these test results that L-menthol is a skin sensitiser in guinea pigs.
In conclusion, L-menthol and thus (±)-neomenthol is not sensitizing and consequently does not require classification for this endpoint as set out in Regulation (EC) No. 1272/2008.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
(±)-neomenthol does not meet the criteria for classification and labelling as skin sensitiser as defined in Regulation (EC) No. 1272/2008 .
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