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EC number: 262-911-1 | CAS number: 61698-32-6
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 14 October 2021 to April 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to the OECD TG 439 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 14 June 2021
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole
- EC Number:
- 262-911-1
- EC Name:
- 4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole
- Cas Number:
- 61698-32-6
- Molecular formula:
- C11H12N2O2
- IUPAC Name:
- [4-(hydroxymethyl)-2-phenyl-1H-imidazol-5-yl]methanol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white to light-pink powder
- Storage: Keep away from heat and sources of ignition. Store in tightly closed container. Store in a well-ventilated place. Store in a cool, dark place.
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in a dry place
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: Stable under storage conditions
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: NA
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: NA
- Reactivity of the test material with the incubation material used (e.g. plastic ware): NA
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): NA
- Preliminary purification step (if any): NA
- Final concentration of a dissolved solid, stock liquid or gel: NA
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): NA
FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution: NA
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE/ Human Epidermis (RHE/S/17)
- Tissue batch number: 21-RHE-147
- Production date: 21 September 2021 (expiry date: 27 September 2021)
- Shipping date: 21 September 2021
- Delivery date: 21 September 2021
- Date of initiation of testing: 21 September 2021
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 x 1mL washes with Phosphate Buffer Saline (DPBS)
- Observable damage in the tissue due to washing: None
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µL
- Incubation time: 3 hours
- Spectrophotometer: ELx800 absorbance microplate reader
- Wavelength: 570 nm
- Filter: n.a.
- Filter bandwidth: n.a.
- Linear OD range of spectrophotometer: Not stated
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Specification: O.D. > 0.7, Result O.D = 1.1 (CV = 7.1%)
- Barrier function: Specification: 4.0h < ET50 < 10.0h
- Morphology: Multi-layered, highly differentiated epidermis consisting of organised basal, spinous and granular layers, and a multilayered stratum corneum.
- Contamination: Cell have been verified the absence of bacteria, fungus and mycoplasma
- Reproducibility: Not stated
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the mean percent viability after 42 minutes exposure and 42 hours (± 1 hour) of post-treatment incubation is > 50%.
- The test substance is considered to be non-corrosive to skin if the mean percent tissue viability after 42 minutes exposure and 42 hours (± 1 hour) of post-treatment incubation is ≤ 50
- Justification for the selection of the cut-off point(s) if different than recommended in TG 439: n/a (same as OECD TG 439) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg
- Concentration (if solution): NA
VEHICLE
- Amount(s) applied (volume or weight with unit): NA
- Concentration (if solution): NA
- Lot/batch no. (if required): NA
- Purity:
NEGATIVE CONTROL
- Amount applied (volume) : 16 µL
- Concentration (if solution): NA
POSITIVE CONTROL
- Amount(s) applied (volume): 16 µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 41 hours ± 1 hour
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 123.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 98.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 87.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none observed
- Direct-MTT reduction: The direct interaction of MTT with the test item was checked by adding 16 mg of the test item to 300 µL of the solution of MTT at 1 mg/mL (same conditions as in the main test). A yellow solution with white test item was observed after 3 hours of incubation between 37.2°C and 37.4°C, 5% CO2.
Therefore, there is no direct interaction between the test item and MTT.
- Colour interference with MTT: The spectral properties at 570 nm of test item in isopropanol were checked by adding 16 mg of the test item to 1.5 mL of isopropanol (same conditions as in the main test). A white solution was obtained after 2 hours of incubation at ambient temperature with gentle shaking.
The solution was centrifuged for 1 minute at 16000 g before dosing the supernatant.
The mean of the corrected OD after centrifugation was 0.319 which is higher than 0.08 (value corresponding to approximately twice the OD of the extracting solvent).
Therefore, the test item was identified as causing colour interference with the viability assay (mean of the corrected OD > 0.08) and two viable control tissues were added to the study which underwent the entire testing procedure but were incubated with medium instead of MTT solution during the MTT incubation step to generate a non-specific colour (NSC living) control.
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes (cf. 'Attachment')
ACCEPTANCE OF RESULTS: ('cf. Attachment')
- Acceptance criteria met for negative control: yes, OD value of the 3 replicates in the range ≥ 0.8 and ≤ 3.0 and the SD value of the % viability ≤ 18%.
- Acceptance criteria met for positive control: yes, Mean Viability < 40%, and SD value of the % viability ≤ 18%.
- Acceptance criteria met for variability between replicate measurements: OD values of the 3 replicates in the range ≥ 0.8 and ≤ 3.0, and SD value of the % viability is 18.4%.
- Range of historical values if different from the ones specified in the test guideline: cf. attachment.
Any other information on results incl. tables
Table 1: Test item - assessment of the skin irritation individual and average values of OD after 42 minutes exposure
Well ID | OD | Mean OD/ disc | Mean OD/product | Viability % | Mean viability % | SD | Conclusion | |
Negative control | SPL_1 | 0.945 0.921 0.923 | 0.930 | 0.868 | 107.1 | 100.0 | 7.9 | |
SPL_2 | 0.762 0.778 0.841 | 0.794 | 91.4 | |||||
SPL_3 | 0.852 0.896 0.895 | 0.881 | 101.5 | |||||
Positive control | SPL_4 | 0.011 0.011 0.011 | 0.011 | 0.011 | 1.3 | 1.3 | 0.1 | Irritant |
SPL_5 | 0.012 0.012 0.011 | 0.012 | 1.4 | |||||
SPL_6 | 0.010 0.013 0.011 | 0.011 | 1.3 | |||||
Test Item PH-21/0755 | SPL_7 | 1.073 1.043 1.096 | 1.071 | 0.895 | 123.3 | 103.1 | 18.4 | |
SPL_8 | 0.857 0.852 0.861 | 0.857 | 98.7 | |||||
SPL_9 | 0.790 0.725 0.759 | 0.758 | 87.3 | |||||
Test Item PH-21/0755 NSC living | SPL_10 | 0.001 0.001 0.001 | 0.001 | 0.001 | 0.1 | 0.1 | 0.1 | |
SPL_11 | 0.000 -0.001 -0.001 | 0.000 | 0.0 | |||||
Test item PH-21/-755 Corrected |
| 103.0 | Non Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean corrected percent viability of the treated tissues was 103.0%. Not classified according to CLP and GHS criteria.
- Executive summary:
In an in vitro skin irritation study (Reconstructed Human Epidermis Test Methods - SkinEthic RHE® model) performed according to the OECD TG No. 439 and in compliance with GLP, 16 mg of undiluted test item was applied to three living reconstructed epidermis for 42 minutes. The application was followed by a rinse with 25 mL of PBS and a 41 hours incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. Additionally, 2 living Human skin model surfaces were treated in the same manner but they were incubated in culture medium instead of MTT solution in order to generate non-specific living color controls.
The mean corrected percent viability of the treated tissues was 103.0% for the test item and 1.3% for the positive control (5% SDS).
The quality criteria required for acceptance of results in the tests were satified:
- SD ≤ 18%
- Negative control: OD value of the 3 replicates in the range ≥ 0.8 and ≤ 3.0 and the SD value of the % viability ≤ 18%.
- Positive control: Mean Viability < 40%, and SD value of the % viability ≤ 18%.
In accordance with the Regulation EC No. 1272/2008, the test item CUREZOL 2PHZ-PW is not considered to be irritating to the skin and therefore classified as a Non-irritant UN GHS No Category.
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