Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- as of 1981
- Deviations:
- no
- GLP compliance:
- yes
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: white solid
- Details on test material:
- - Name of test material (as cited in study report): 90/620105
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding Centre ApS, Ejby, Skensved, Denmark
- Age at study initiation: not reported
- Weight at study initiation: 1800 to 2700 g
- Housing: individually in PPL cages, 45 x 55 cm, with perforated floor
- Diet (e.g. ad libitum): Altromin 2123, Chr. Petersen A/S, Ringsted, Denmark ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12 hours darkness, 12 hours light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: mixture of ethanol 96% and diethylphthalate (1:1)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of moistened test material
- Concentration (if solution): 50%, 10% and 1% by weight
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of test solution, i.e. test substance dissolved in a mixture of ethanol 96% and diethylpthalate (1:1) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: the test substance was applied to two anterior, two posterior and one centrally located site
- % coverage: not reported
- Type of wrap if used: treatment sites were covered with gauze packs that were secured with adhesive tape and fixed with Scanpore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned with soap and lukewarm water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injury in depth): 4
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm, extending beyond area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24, 48 and 72 hours after removal
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None of the animals treated with 100% showed an erythema or oedema score that would trigger classification. The scores for erythema and oedema formation were slightly higher for the test sites treated with 50% in a mixture of ethanol 96% and diethylphthalate (1:1), however, scores were not triggering classification at a test concentration of 50%. Corrosiveness to the skin was not observed. After the observation period of 14 days, few animals had sites with scattered small white scales, but the underlying skin was intact. All effects were considered to be fully reversible within 14 days.
- Other effects:
- No effects observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was not irritating to the rabbit skin when tested purely or in dilution. All effects observed at observation time points at 24, 48 and 72 hours after patch removal were fully reversible within a period of 14 days.
- Executive summary:
The skin irritation potential of the test substance menthyl lactate was studied under GLP in accordance with OECD TG 404. The pure substance (wetted with the vehicle ethanol 96%:diethylphthalate, 1:1) or dilutions of the test substance in the vehicle at 50%, 10% and 1% were applied for four hours under occlusion to five sites on the clipped, intact skin of six female rabbits of the stock Mol:Russian (1800 to 2700 g). After patch removal the skin was washed with soap and water. Animals were then observed for a period of 14 days and scorings of the skin were made at 24, 48 and 72 hours after patch removal. The substance or its dilutions were not corrosive to the rabbit skin. None of the individual mean scores for erythema or oedema were above 2 with the neat substance or above 2.33 with the 50% dilution. All observed effects were fully reversible within the observation period of 14 days. The substance therefore was considered to be not irritating to the rabbit skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.