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Diss Factsheets
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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 132 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 661 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation Systemic effects - Long-term: Based on the toxicokinetic data, it can be assumed that the systemic bioavailability will be high both after oral and inhalation exposure; no correction factor for oral-to-inhalation extrapolation was applied.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL from chronic study
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- for workers; R8, ECHA 2008
- AF for the quality of the whole database:
- 1
- Justification:
- based on validity of studies performed
- AF for remaining uncertainties:
- 1
- Justification:
- (a factor 1 was used for remaining interspecies differences, because 375 mg/kg/day was the highest dose tested in the chronic study and did not cause any effects, suggesting that the NOAEL would have been higher, and the level did also not cause any effects on other species, namely in the mouse at the highest tested dose of 667 mg/kg/day in a chronic study, in the hamster at the highest tested dose of 405 mg/kg/day in a teratogenicity study, and in the rabbit at the highest tested dose of 425 mg/kg/day in a teratogenicity study, which does not indicate any relevant species differences in susceptibility
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: VCI document "Ableitung von DNEL für lokal reizende Stoffe mit guter Datenlage zur systemischen Toxizität, aber limitierter Datenlage zur Inhalationstoxizität" see attachment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: VCI document "Ableitung von DNEL für lokal reizende Stoffe mit guter Datenlage zur systemischen Toxizität, aber limitierter Datenlage zur Inhalationstoxizität" see attachment
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 375 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal Systemic effects - Long-term: Based on the toxicokinetic data, it can be assumed that the systemic bioavailability will be not higher after dermal exposure compared to oral exposure; no correction factor is applied
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- according to R8, ECHA 2008
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- for workers; see R8, ECHA 2008
- AF for the quality of the whole database:
- 1
- Justification:
- based on validity of studies performed
- AF for remaining uncertainties:
- 1
- Justification:
- a factor 1 was used for remaining interspecies differences, because 375 mg/kg/day was the highest dose tested in the chronic study and did not cause any effects, suggesting that the NOAEL would have been higher, and the level did also not cause any effects on other species, namely in the mouse at the highest tested dose of 667 mg/kg/day in a chronic study, in the hamster at the highest tested dose of 405 mg/kg/day in a teratogenicity study, and in the rabbit at the highest tested dose of 425 mg/kg/day in a teratogenicity study, which does not indicate any relevant species differences in susceptibility
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The local effect long term and acute exposure assessment has taken into consideration hazards to eyes together with skin hazards, as described in attached VCI-document "Ableitung von DNEL für lokal reizende Stoffe mit guter Datenlage zur systemischen Toxizität, aber limitierter Datenlage zur Inhalationstoxizität". In addition workers operating with chemicals, as a minimum use eye protection as default which is also communicated as a standard minimum requirement via Safety Data Sheets. Taking into consideration that the eye irritating potential is rather low, at the lower end of CLP classification criteria, leading to classification according to CLP but not according to DSD. Concentrations below 25% are not irritating. Conclusion is that L Menthol is of medium hazard.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 33 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 326 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Based on the toxicokinetic data, it can be assumed that the systemic bioavailability will be high both after oral and inhalation exposure; thus no correction factor for oral-to-inhalation extrapolation was applied.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL from chronic study
- AF for intraspecies differences:
- 10
- Justification:
- for general population; R8, ECHA 2008
- AF for the quality of the whole database:
- 1
- Justification:
- based on validity of studies performed
- AF for remaining uncertainties:
- 1
- Justification:
- a factor 1 was used for remaining interspecies differences, because 375 mg/kg/day was the highest dose tested in the chronic study and did not cause any effects, suggesting that the NOAEL would have been higher, and the level did also not cause any effects on other species, namely in the mouse at the highest tested dose of 667 mg/kg/day in a chronic study, in the hamster at the highest tested dose of 405 mg/kg/day in a teratogenicity study, and in the rabbit at the highest tested dose of 425 mg/kg/day in a teratogenicity study, which does not indicate any relevant species differences in susceptibility
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 375 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Based on the toxicokinetic data, it can be assumed that the systemic bioavailability will be high both after oral and dermal exposure; no correction factor is applied.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- R8, ECHA 2008
- AF for intraspecies differences:
- 10
- Justification:
- for general population; R8, ECHA 2008
- AF for the quality of the whole database:
- 1
- Justification:
- based on validity of studies performed
- AF for remaining uncertainties:
- 1
- Justification:
- a factor 1 was used for remaining interspecies differences, because 375 mg/kg/day was the highest dose tested in the chronic study and did not cause any effects, suggesting that the NOAEL would have been higher, and the level did also not cause any effects on other species, namely in the mouse at the highest tested dose of 667 mg/kg/day in a chronic study, in the hamster at the highest tested dose of 405 mg/kg/day in a teratogenicity study, and in the rabbit at the highest tested dose of 425 mg/kg/day in a teratogenicity study, which does not indicate any relevant species differences in susceptibility
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 375 mg/kg bw/day
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- R8, ECHA 2008
- AF for intraspecies differences:
- 10
- Justification:
- for general population; R8, ECHA 2008
- AF for the quality of the whole database:
- 1
- Justification:
- based on validity of studies performed
- AF for remaining uncertainties:
- 1
- Justification:
- a factor 1 was used for remaining interspecies differences, because 375 mg/kg/day was the highest dose tested in the chronic study and did not cause any effects, suggesting that the NOAEL would have been higher, and the level did also not cause any effects on other species, namely in the mouse at the highest tested dose of 667 mg/kg/day in a chronic study, in the hamster at the highest tested dose of 405 mg/kg/day in a teratogenicity study, and in the rabbit at the highest tested dose of 425 mg/kg/day in a teratogenicity study, which does not indicate any relevant species differences in susceptibility
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
L Menthol is classified as eye irritant in concentrations as of 25% and above. It should be taken into consideration that the eye irritating potential is rather low, at the lower end of CLP classification criteria, leading to classification according to CLP but not according to DSD. Concentrations below 25% are not irritating. The general population is exposed only to low concentrations of L Menthol and thus no effects have to be taken into consideration for general population.
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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