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Diss Factsheets
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EC number: 201-911-8 | CAS number: 89-48-5
- 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
Description of key information
Oral: LD50 > 5000 mg/kg body weight leading to not classification according to CLP
Dermal: LD50 > 5000 mg/kg body weight leading to not classification according to CLP
Inhalation: no information available
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1972-05-25 to 1972-05-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP, similar to OECD TG 401
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not reported
TEST ANIMALS
- Fasting period before study: 24 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- no data
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: clinical signs - Statistics:
- no data
- Preliminary study:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female rat died on day 1 during the observation period of 14 days.
- Clinical signs:
- other: Morbidity noted in two rats soon after dosing followed by prostration and coma resulting in death of one female rat.
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was acutely non toxic to rats in an acute oral toxicity test with an LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
- Executive summary:
The acute oral toxicity of menthyl acetate was studied in a non-GLP test according to principles slightly deviating from those of current guidelines. 5 animals per sex were exposed to single oral dose of 5000 mg/kg bw. Animals were observed during a period of 14 days. Morbidity was noted in two rats soon after dosing followed by prostration and coma resulting in death of one female rat. The LD50 value was >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Only one key study is available. This study is similar to OECD TG 401.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP, similar to OECD TG 402
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- 3 abraded rabbits
- Principles of method if other than guideline:
- Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- no data
- Duration of exposure:
- no data
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
-3 animals dosed on intact and 3 on abraded skin. - Statistics:
- no data
- Preliminary study:
- no data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were observed.
- Clinical signs:
- other: Mild erythema followed by slight drying and cracking of skin.
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was acutely not toxic to rabbits in an acute dermal toxicity test with a LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
- Executive summary:
The acute dermal toxicity of menthyl acetate was studied in a non-GLP test according to the method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961. Group of six animals (3 intact and 3 abraded skin) were exposed to single dermal dose of 5 g/kg bw. Animals were observed during a period of 14 days. No mortality was reported within observation period. The LD50 value was >5 g/kg bw. As symptoms, mild erythema followed by slight drying and cracking of skin was reported.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Only one study is available in whole database for the acute dermal toxicity. This study is similar to OECD TG 402.
Additional information
- oral toxicity:
The substance menthyl acetate is not acutely toxic to rats in an acute oral toxicity study and the oral LD50 value is above 5000 mg/kg body weight (Moldovan 1972).
- dermal toxicity:
The substance menthyl acetate is not acutely toxic in an acute dermal toxicity study in rabbits with a dermal LD50 value above 5000 mg/kg body weight (Moldovan 1972).
Dermal and oral routes of exposure are considered to be the most likely routes of human exposure to this fragrance substance. Overall, the registration item exhibits no acute toxicity.
Justification for selection of acute toxicity – oral endpoint
A reliable with restrictions key study similar to OECD TG 401.
Justification for selection of acute toxicity – dermal endpoint
A reliable with restrictions key study similar to OECD TG 402.
Justification for classification or non-classification
- oral toxicity:
Based on the above stated assessment of the acute oral toxicity of menthyl acetate, the results from reliable with restrictions study are above the threshold value given in the CLP Regulation. Therefore menthyl acetate does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
- dermal toxicity:
Based on the above stated assessment of the acute dermal toxicity, menthyl acetate does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
- inhalation toxicity:
No inhalation studies are available and due to exposure considerations the conduct of studies and the classification and labelling for this endpoint is deemed not to be necessary.
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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