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EC number: 941-717-7 | CAS number: -
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: component of reaction mass
- Adequacy of study:
- key study
- Study period:
- July-August 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to ECVAM ToxRTool reliability 2. GLP study performed according to OECD guideline 405 of february 1987. Deficiencies: The description of the study results is not transparent and without further information missleading.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- L-menthol
- EC Number:
- 218-690-9
- EC Name:
- L-menthol
- Cas Number:
- 2216-51-5
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1R,2S,5R)-2-isopropyl-5-methyl-cyclohexanol
- Reference substance name:
- Cyclohexanol, 5-methyl-2-(1-methylethyl)-, [1R-(1.α.,2.β.,5.α.)]-
- IUPAC Name:
- Cyclohexanol, 5-methyl-2-(1-methylethyl)-, [1R-(1.α.,2.β.,5.α.)]-
- Reference substance name:
- HR 89/620001
- IUPAC Name:
- HR 89/620001
- Details on test material:
- - Substance type: White crystalline powder (tiny crystals)
- Physical state: solid
- 64.3 % solubilised in diethyl phthalate
Substance purity : 99.7%
Expiration date of the lot : not stated
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Chbb:HM, C.H. Boehringer, Biberach:Himalaya
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: SPF albino female rabbits Chbb:HM, C.H. Boehringer, Biberach; Himalaya
- Source: Dr Karl Thomae GmbH, D-7950 Biberach an der Riss 1.
- Weight at study initiation: 2600 to 2800 g
- Housing: Single PPL cages 45x55 cm with perforated floor
- Diet (e.g. ad libitum): free access to food pellets "Altromin 2123" from Chr. Petersen Ltd, DK-4100 Ringsted
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
- Controls: internal control (right eye)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 6 times an hour
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Test system
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration 1 28.6%(W7W) L-Menthol in Dieethyl Phthalate (DEP) (in studie stated as vehicle)
- Concentration 2 :50 g L-Menthol + 50 g 28.6% (w/w) L-Menthol in DEP = 64.3% (w/w) in DEP - Duration of treatment / exposure:
- No removal after application. Once applied the test material remained in contact with the eye throughout the experiment.
- Observation period (in vivo):
- Observation at 1 hour, 24 hours, 48 hours and 72 hours and 7 days.
- Number of animals or in vitro replicates:
- 4 rabbits tested (female) for each concentration
- Details on study design:
- The day before testing both eyes of the animals were examined with an ophthalmoscope to ensure there were no eye defects or irritation. The examination was performed before and after instillation of oculoguttae flouresceini (Pb.N.),
Both the left and right eyes were treated. The right eyes with the vehicle and the left eyes with the test article solution.
About 0.1 ml of the test article concentration 1 or test article concentration 2 was placed in the left or right eye, respectively, of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for about one second. The eyes were examined and the grade of ocular reaction was recorded 1 hour later. 24 hours later an examination was performed before and after instillation of oculoguttae flouresceini. After the examination the eyes were rinsed with 20 ml of a 0.9% sodium chloride solution
The eyes were also examined 48 and 72 hours after the treatment, as well as on day 7.
SCORING SYSTEM: see table below
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: over all time points
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: low concentration score 0.8
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- mean
- Time point:
- other: over all time points
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: low concentration score 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: over all time points
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: low concentration score 1.2
- Irritation parameter:
- conjunctivae score
- Remarks:
- oedema
- Basis:
- mean
- Time point:
- other: over all time points
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: low concentration score 0.3
- Irritant / corrosive response data:
- For further details see table below
Any other information on results incl. tables
Rabbit |
Conjunctiva Discharge |
Conjunctiva Redness |
Conjunctiva Chemosis |
Iris |
Cornea |
Opacity area (with fluoresceine) |
#1 at 1 h |
3 |
2 |
1 |
0 |
1 |
1 |
#1 at 24 h |
1 |
2 |
1 |
0 |
1 |
4 (4) |
#1 at 48 h |
0 |
2 |
0 |
0 |
1 |
3 (3) |
#1 at 72 h |
0 |
1 |
0 |
0 |
1 |
3 (3) |
#1 at 7 d |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
#2 at 1 h |
3 |
2 |
1 |
0 |
1 |
2 |
#2 at 24 h |
1 |
3 |
1 |
0 |
1 |
4 (4) |
#2 at 48 h |
0 |
2 |
0 |
0 |
1 |
2 (2) |
#2 at 72 h |
0 |
1 |
0 |
0 |
1 |
1 (1) |
#2 at 7 d |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
#3 at 1 h |
3 |
2 |
0 |
0 |
1 |
1 |
#3 at 24 h |
1 |
3 |
2 |
0 |
1 |
4 (4) |
#3 at 48 h |
0 |
3 |
1 |
0 |
1 |
4 (4) |
#3 at 72 h |
0 |
2 |
1 |
0 |
1 |
3 (3) |
#3 at 7 d |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
#4 at 1 h |
3 |
2 |
1 |
0 |
1 |
3 |
#4 at 24 h |
1 |
2 |
1 |
0 |
1 |
4 (4) |
#4 at 48 h |
0 |
2 |
0 |
0 |
1 |
3 (3) |
#4 at 72 h |
0 |
1 |
0 |
0 |
1 |
1 (1) |
#4 at 7 d |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
24, 48 and 72 h mean |
0.3 |
2.0 |
0.6 |
0.0 |
1.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Eye irritant category 2 under CLP, but does not meet eye irritant criteria under DSD. Criteria used for interpretation of results: EU
- Conclusions:
- Menthols causes moderate to intense reactions of rabbit eye cornea and conjunctiva, which is complete reversible within 7 days.
- Executive summary:
The primary eye irritant effect of menthols was investigated using L Menthol in concentration of 29% and 64% according to the method recommended in the OECD Guideline No.405,“Acute Eye Irritation/Corrosion”, Feb. 1987.
Under the experimental conditions described in the report, moderate to intense reactions of cornea and conjunctiva were seen in all rabbits according to the used menthol concentration.
All effects seen were fully reversible within 7 days.
Menthols should be classified as eye irritant category 2 under CLP but does not require classification for eye irritation/corrosion under DSD.
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