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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Description of key information
The substance was neither irritating to the skin nor irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- as of 1981
- Deviations:
- no
- GLP compliance:
- yes
- 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 - 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 - 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted under GLP-conditions in accordance with Guideline No 405.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- from February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- from January 1997
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg
- Age at study initiation: not reported
- Weight at study initiation: 2.8 - 3.2 kg bw
- Housing: caged individually in PPO cages (floor area: 2576 cm2) with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet Altromin 2123 from Altromin, D-32791 Lage/Lippe, Germany, ad libitum
- Water (e.g. ad libitum): free access to domestic quality drinking watet acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single administration; after 24 hour reading Fluorescein was instilled and treated eye was washed with 20 mL 0.9% sodium chloride solution
- Observation period (in vivo):
- The eyes were examined on the day before testing and 1, 24, 48 and 72 hours after the treatment.
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- substance was not removed from the treated eye
SCORING SYSTEM:
see section "Any other information on materilas and methods incl. tables"
TOOL USED TO ASSESS SCORE:
Fluorescein was instilled after 24 hours, eyes were rinsed with 20 mL 0.9% sodium chloride solution and were examined using UV light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after application of the test article all animals showed a diffuse crimson red conjunctiva with individual vessels not easily discernible and some swelling above normal. After 24 hours all animals showed some conjunctival vessels definitely injected. After 48 and 72 hours all animals were free of any signs of eye irritation.
- Other effects:
- No other effects were reported.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is non irritating to the rabbit eye.
- Executive summary:
The potential for eye irritation was tested for methyl acetate in a GLP study according to OECD guideline No. 405. Four female albino rabbits weighing 2.8 to 3.2 kg were used in the study. The day before testing both eyes of the animals were examined before and after the instillation of Fluorescein to ensure there were no defects or irritation. The next day an aliquot of 0.1 mL of the neat substance was placed in the left eyes of the animals by gently pulling the lower lid away from the eyeball. The lids were then gently hold together for one second. The right eye remained untreated and served as control. The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours later. After a first reading at 24 hours, Fluorescein was instilled and the treated eye was rinsed with 20 mL 0.9 % sodium chloride solution. Then the eye was examined again using UV-light to detect possible corneal damage. Further gradings were done after 48 and 72 hours after treatment. One hour after application of the test article all animals showed a diffuse crimson red conjunctiva with individual vessels not easily discernible and some swelling above normal. After 24 hours all animals showed some conjunctival vessels definitely injected. After 48 and 72 hours all animals were free of any signs of eye irritation. On the basis of these observations it was concluded that the substance is non-irritating to the rabbit eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
- skin irritation / corrosion
In the key study, the pure substance was applied for four hours under occlusion to five sites in the clipped, intact skin of six female rabbits of the stock Mol:Russian. The substance was not corrosive to the rabbit skin. None of the individual mean scores (24, 48 and 72 hours after removal) of erythema or oedema were above 2. 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 (Skydsgaard 1990).
In a non-guideline and non-GLP supporting study 50 % solution of the test substance in olive oil was applied daily for 5 days to the shaved skin flanks of 12 guinea pigs. No skin reactions were observed after this treatment, which is in line with the key study result (Hopf 1976).
- eye irritation
50 % of menthyl lactate diluted in olive oil was not irritating in the eyes of 8 tested rabbits. The study was not performed under GLP conditions and not according to OECD or EU guidelines.
The read across substance menthyl acetate was not irritating in rabbit eyes.
Menthyl lactate was investigated in the Hen's Egg Test - Chorioallantoic Membrane (HET-CAM). A 50 % solution of the test substance in diethylphthalate applied to the vital, vascularised chorionallantois membrane produced clear signs of irritation including vascular injection, hemorrhage, lysis and coagulation. Since the HET-CAM test is still not validated and the method evaluation report of ICCVAM from 2006 demonstrates that the chemical class of alcohols could lead in 88% to false positive test results it is likely that the menthyl lactate result in HET-CAM was a false positive result too, especially taking the no response in rabbit eyes and the "no skin reactions" into account.
Justification for selection of skin irritation / corrosion endpoint:
The key in vivo study is valid and reliable. The substance is not irritating or corrosive to skin.
Justification for selection of eye irritation endpoint:
Menthyl lactate administered to rabbit eyes according to the method of Draize was not irritating (reliable 3). The read across substance Menthyl acetate was not irritating in rabbit eyes (reliability 1).
Justification for classification or non-classification
- skin irritation/corrosion:
Based on the above stated assessment of the irritating properties of menthyl lactate, the results from reliable in vivo studies show that the substance is not irritating to the skin. Accordingly the test item 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.
- eye irritation / corrosion:
Based on the above stated assessment of the irritating properties of menthyl lactate, the results from the in vivo study and the valid study with read across substance menthyl acetated show that the substance is not irritating to the eye. Accordingly the test item 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.
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.