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EC number: 612-179-8 | CAS number: 61597-98-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-02-10 to 1984-03-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed under GLP conditions and similar to OECD guideline 401;
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Menthyl lactate
- IUPAC Name:
- Menthyl lactate
- Reference substance name:
- Methyl lactate
- EC Number:
- 208-930-0
- EC Name:
- Methyl lactate
- Cas Number:
- 547-64-8
- IUPAC Name:
- methyl 2-hydroxypropanoate
- Reference substance name:
- Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-
- EC Number:
- 612-179-8
- Cas Number:
- 61597-98-6
- Molecular formula:
- C13H24O3
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-
- Test material form:
- other: solution in corn oil
- Details on test material:
- - Name of test material (as cited in study report): L-Menthyl Lactate
- Physical state: liquid
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc., Wilmington, USA
- Age at study initiation: young adults animals
- Weight at study initiation: males: 227.6 to 265.6 g; females: 192.8 to 210.2 g (values given as averages for different dose groups on day 1 of the experiment)
- Fasting period before study: overnight fasting
- Housing: individually in wire mesh bottom cages
- Diet (e.g. ad libitum): NIH open formula 07, Zeigler Brothers, Gardners, USA ad libitum
- Water (e.g. ad libitum): fresh tap water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not given
- Amount of vehicle (if gavage): substance was adiministered in 10 mL of corn oil
- Justification for choice of vehicle: use of vehicle not justified
- Lot/batch no. (if required): not given
- Purity: not given - Doses:
- Limit test: 5000 mg/kg
Main test: 2000 mg/kg; 2828 mg/kg; 4000 mg/kg; 5657 mg/kg; 8000 mg/kg; 9514 mg/kg - No. of animals per sex per dose:
- Each dose was administered to 5 male and 5 females.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency of weighing: on day 1, 8 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 values were calculated according to Finney DJ (1971), Statistical methods in biological assays, second edition, London: Griffin Press.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 7 871 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 972 - 13 025
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 6 571 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 4 807 - 11 212
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 7 257 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 971 - 9 675
- Mortality:
- No mortality of male rats occurred at doses up to 4000 mg/kg, one animal died at 5657 mg/kg, two animals died at 8000 mg/kg and 4 animals died at 9514 mg/kg. No mortality of female rats occurred at 2000 and 4000 mg/kg, one animal died at 2828 mg/kg, two animals died at 5657 and 8000 mg/kg each and all five animals died at 9514 mg/kg.
- Clinical signs:
- other: Observed clinical signs included decreased activity, ataxia, diarrhoea, lacrimation, wet abdomen and salivation.
- Gross pathology:
- Few observations were made during gross pathology including red spots of 1mm diameter on the cortical surface of kidneys (except at 5657 and 9514 mg/kg) and intestines of dark red colour containing blood-like viscous liquid (at 8000 mg/kg).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- L-Menthyl-Lactate is not acutely toxic via the oral route with a LD50 of 7257 mg/kg body weight. The substance is not classified according to CLP.
- Executive summary:
Frescolat/L-Menthyl Lactate 620105 was evaluated for acute oral toxicity (LD50) in male and female Sprague-Dawley rats. A limit test at 5000 mg/kg bw and a regular test with five dose levels ranging from 2000 to 9514 mg/kg bodyweight were performed. In the latter, five separate solutions of the sample corresponding to five doses were prepared in corn oil immediately prior to administration. All solutions were administered to overnight fasted animals at a volume of 10 mL/kg bodyweight. All animals were observed for mortality and toxic signs at least twice daily, for 14 days. Necropsy was performed with all animals. The calculated acute oral LD50 of the test article in male rats was found to be 7871 mg/kg body weight with a 95% confidence interval of 5972 to 13025 mg/kg. The calculated LD50 for females was found to be 6571 mg/kg body weight with a 95% confidence interval of 4807 to 11212 mg/kg body weight and the combined LD50 was calculated to be 7257 mg/kg body weight with a 95% confidence interval of 5971 to 9675 mg/kg.
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