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EC number: 220-076-0 | CAS number: 2623-23-6
- 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
No studies are available for L-menthyl acetate. Reliable data are available with the structural analogue menthyl acetate (CAS 89-48-5).
Skin: The test substance was shown to be not irritating to skin.
Eyes: The test substance was found to be non-irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2012-05-14 to 2012-08-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD TG 439
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Justification for test system used:
- Because systemic reactions play a minor role in modulating local skin toxicity potential of chemicals, skin irritation potential may be predicted by in vitro systems, provided they are sufficiently complex to mimic human skin barrier and cell reactivity. In an international prevalidation study performed by ECVAM, the in vitro skin irritation test using the human skin model EpiDerm™ and EpiSkin™ and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt have turned out as a sufficiently promising predictor for skin irritancy potential.
- Details on test animals or test system and environmental conditions:
- not relevant
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 15 min treatment + 42 h incubation
- Number of animals:
- not relevant
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with PBS
- Time after start of exposure: 15 min
SCORING SYSTEM:
In vitro result: In vivo prediction:
mean tissue viability ≤ 50 % → irritant (I), H315 (category 2)
mean tissue viability > 50 % → non-irritant (NI) - Irritation / corrosion parameter:
- other: other: Relative Absorbance
- Value:
- 105.3
- Remarks on result:
- other:
- Remarks:
- Basis: other: Test item on EpiSkin. Max. score: 100.0. Reversibility: no data. Remarks: % of negative control. (migrated information)
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean relative absorbance value of the test item, corresponding to the cell viability, did not decrease (105.3%; threshold for irritancy: ≤ 50%), consequently the test item was non irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Menthyl Acetate racemic by means of the Human Skin Model Test according to OECD TG 439. Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. 10 μL of the liquid test item were applied to each tissue, spread to match the tissue size. 10 μL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue. After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD 0.6 till ≤ 1.5 for the 15 minutes treatment interval thus showing the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 15 minutes treatment interval thus ensuring the validity of the test system. Compared to the value of the negative control, after exposure of the test item Menthyl Acetate racemic the mean relative absorbance value did not decrease (105.3%; threshold for irritancy of ≤ 50%). Therefore, the test item is not considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Menthyl Acetate racemic is non irritant to skin according to UN GHS and EU CLP regulation.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to the attached read across justification in section 13. - Reason / purpose for cross-reference:
- read-across source
- Irritation / corrosion parameter:
- other: Relative Absorbance
- Value:
- 105.3
- Remarks on result:
- other: Basis: other: Test item on EpiSkin. Max. score: 100.0. Reversibility: no data. Remarks: % of negative control. (migrated information)
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- L-menthyl acetate is estimated to be not irritant to skin.
- Executive summary:
One study is available from structural analogue menthyl acetate CAS 89-48-5. This in vitro study was performed to assess the irritation potential by means of the Human Skin Model Test according to OECD TG 439. Compared to the value of the negative control, after exposure of the test item the mean relative absorbance value did not decrease (105.3%; threshold for irritancy of ≤ 50%). Therefore, the test item is not considered to possess an irritant potential.
Referenceopen allclose all
Results after treatment with menthyl acetate racemic and controls
Dose group |
Treat-ment interval |
Absor-bance 540 nm Tissue 1* |
Absor-bance 540 nm Tissue 2* |
Absor-bance 540 nm Tissue 3* |
Mean Absorbance of 3 Tissue |
Relative absor-bance [%] Tissue 1, 2+3** |
Stan-dard De-viation [%] |
Rel. Absor-bance [% of negative control]*** |
Negative Control |
15 min |
1.154 |
1.047 |
1.032 |
1.077 |
107.1 97.2 95.8 |
6.2 |
100.0 |
Positive Control |
15 min |
0.175 |
0.142 |
0.154 |
0.157 |
16.3 13.2 14.3 |
1.6 |
14.6 |
Test Item |
15 min |
1.175 |
1.050 |
1.178 |
1.134 |
109.0 97.5 109.4 |
6.8 |
105.3 |
*Mean of two replicate after blank correction
**Relative absorbance per tissue [rounded values]: 100xabsorbance (tissue)/mean absorbance (negative control)
***Relative absorbance per treatment group [rounded values]: 100xmean absorbance (test item)/mean anbsorbance (negative control)
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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- 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:
- GHS criteria not met
- 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.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to the attached read across justification in section 13. - Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- 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:
- GHS criteria not met
- Conclusions:
- The substance is estimated to be non irritating to the rabbit eye.
- Executive summary:
One study is available from structural analogue menthyl acetate CAS 89 -48 -5. It is concluded that L-menthyl acetate is not irritating to eyes.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
An in vitro study was performed to assess the irritation potential of Menthyl Acetate racemic by means of the Human Skin Model Test according to OECD TG 439. Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. 10 μL of the liquid test item were applied to each tissue, spread to match the tissue size. 10 μL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue. After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD 0.6 till ≤ 1.5 for the 15 minutes treatment interval thus showing the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 15 minutes treatment interval thus ensuring the validity of the test system. Compared to the value of the negative control, after exposure of the test item Menthyl Acetate racemic the mean relative absorbance value did not decrease (105.3%; threshold for irritancy of ≤ 50%). Therefore, the test item is not considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Menthyl Acetate racemic is non irritant to skin according to UN GHS and EU CLP regulation.
Eyes:
The potential for eye irritation was tested for methyl acetate racemic 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.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin and eye irritationthe
test item is not classifiedaccording
to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in
Regulation (EU) No 2016/918.
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