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EC number: 947-851-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 February 2018 to 23 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (2015)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- D,L- Menthol / D,L-Isomenthol
- Molecular formula:
- C10H20O
- IUPAC Name:
- D,L- Menthol / D,L-Isomenthol
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Reconstructed epidermis of normal human keratinocytes, originating from adult donors
- Source strain:
- other: Keratinocyte strain: 00267
- Justification for test system used:
- The test is based on the experience that irritant chemicals show cytotoxic effects following short term exposure to the stratum corneum of the epidermis. The test is designed to predict and classify the skin irritation potential of a test item by assessment of its effect on a three dimensional human epidermis model.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKINTM and EPIDERMTM)
- Tissue batch number(s): 25888
- Expiration date: Not specified
- Shipping date: March 20th 2018
- Date of initiation of testing: March 20th 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature
- Temperature of post-treatment incubation (if applicable): All incubations were carried out at 37.0 ± 1.5⁰ C.
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were washed with DPBS to
remove residual test item after exposure period.
- Observable damage in the tissue due to washing: Not specified.
- Modifications to validated SOP: The tissues were rinsed with PBS instead of DPBS to remove any residual material.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: (1 mg/mL)
- Spectrophotometer: Microplate reader (Versamax® Molecular Devices) .
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- No. of replicates: 3
PREDICTION MODEL / DECISION CRITERIA
-The test substance is considered to be an irritant to skin if the relative mean tissue viability after a 15-minute exposure period followed by the 42-Hour post-exposure incubation period is less than 50% of the mean viability of the negative controls.
-The test substance is considered to be non-irritant to skin if the relative mean tissue viability after a 15-minute exposure period followed by the 42-Hour post-exposure incubation period is greater than 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 +/- 2mg (approx. 39 mg/cm2) wettd with 25µL DPBS
- Concentration (if solution): Not applicable.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25µL
- Concentration (if solution): Not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL Sodium dodecyl sulphate
- Concentration (if solution): 5 % - Duration of treatment / exposure:
- 15 Minutes
- Duration of post-treatment incubation (if applicable):
- Subsequently the skin tissues were incubated for 42 hours at 37°C.
- Number of replicates:
- 3 test replicates.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 4.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 3.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 7.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - Acceptance criteria met for negative control: The negative control value from the study had a mean relative tissue viability of 100% and a mean OD570 of 1.718 which is within the historic control data
range.
- Acceptance criteria met for positive control: The mean relative tissue viability of the positive control was ≤50% (2.9%) and the mean OD570 was 0.051 which is within the historic control data range.
- Acceptance criteria met for variability between replicate measurements: The standard deviation for the negative control was within the acceptance criteria of ≤18 for the percentage viability (8.5%). The standard deviation for the positive control was within the acceptance criteria of ≤18 for the percentage viability (0.1%). All validity criteria were met.
Any other information on results incl. tables
Table 1- Results of treatment with test item and controls
Treatment Group | Tissue number | OD 570 nm well 1 | OD 570 nm well 2 | OD 570 nm well 3 | Mean OD of 3 wells | Mean OD of 3 wells blank corrected | Mean OD of 3 tissues blank corrected | Rel. viability [%] Tissue 1,2 +3* | Standard deviation | Mean Rel. viability [%]** |
Blank | 0.039 | 0.038 | 0.038 | 0.038 | ||||||
Negative control |
1 2 3 |
1.947 1.668 1.750 |
1.888 1.598 1.717 |
1.908 1.614 1.714 |
1.914 1.627 1.727 |
1.876 1.589 1.689 |
1.718 |
109.2 92.5 98.3 |
8.5
|
100.0
|
Postive control |
1 2 3 |
0.089 0.091 0.088 |
0.088 0.088 0.086 |
0.088 0.093 0.087 |
0.089 0.091 0.087 |
0.050 0.053 0.049 |
0.051
|
2.9 3.1 2.8 |
0.1 | 2.9 |
Test item | 1 2 3 |
0.090 0.097 0.177 |
0.090 0.095 0.171 |
0.090 0.096 0.174 |
0.090 0.096 0.174 |
0.052 0.058 0.136 |
0.082
|
3.0 3.4 7.9 |
2.7 | 4.8 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In conclusion, the test item is a skin irritant according to CLP (H315) and GHS (category 2).
- Executive summary:
The study is assigned a reliability score of 1 (reliable without restrictions) as it followed OECD Guideline 439: In Vitro Skin irritation: Reconstructed Human Epidermis (RHE) Test and it is compliant with GLP. 25 +/-2 mg of the test item (approx 39 mg/cm2 according to guideline) was wetted with 25 µL of DPBS and applied to the EpiSkin tissue for 15 minutes followed by a 42-hour post-exposure incubation period. Negative and positive controls were also tested. The positive control had a mean cell viability of 2.9%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was < 7%.
Therefore, all validity criteria were met. The substance under test conditions had a mean tissue viability of 4.8% compared to the negative control. This value is below the threshold for irritancy (≤50%). This concludes the test item is a skin irritant (Category 2).
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