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EC number: 246-042-5 | CAS number: 24155-42-8
- 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 July 31st to October 9th, 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- α-(2,4-dichlorophenyl)-1H-imidazole-1-ethanol
- EC Number:
- 246-042-5
- EC Name:
- α-(2,4-dichlorophenyl)-1H-imidazole-1-ethanol
- Cas Number:
- 24155-42-8
- Molecular formula:
- C11H10Cl2N2O
- IUPAC Name:
- 1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethan-1-ol
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 15-30ºC, in tightly closed container.
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN-SM
- Source species:
- human
- Cell type:
- other: adult human-derived epidermal keratinocytes
- Cell source:
- other: human adult donors, not specified.
- Source strain:
- not specified
- Details on animal used as source of test system:
- EPISKIN-SM (Manufacturer: SkinEthic, France, Batch No.:13-EKIN-030, Expiry Date: 09 September 2013)
- Justification for test system used:
- The EPISKIN model has been validated for irritation testing in an international trial. After a review of scientific reports and peer reviewed publications on the EPISKIN method, it showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation, when the endpoint is evaluated by MTT reduction and for being used as a replacement for the Draize Skin Irritation test (OECD TG 404 and Method B.4 of Annex V to Directive 67/548/EEC) for the purposes of distinguishing between skin irritating and no- skin irritating test substances (STATEMENT OF VALIDITY OF IN-VITRO TESTS FOR SKIN IRRITATION; ECVAM; Institute for Health & Consumer Protection; Joint Research Centre; European Commission; Ispra; 27 April 2007).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM (Manufacturer: SkinEthic, France)
- Tissue batch number(s): 13-EKIN-030
- Expiry Date: 09 September 2013
- Date of initiation of testing: 05 September 2013
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: Exposure of test material was terminated by rinsing thoroughly with PBS 1x solution. The rest of the PBS was removed from the epidermal surface with suitable pipette tip linked to a vacuum source (care was taken to avoid the damage of epidermis).
- Observable damage in the tissue due to washing: no.
- Modifications to validated SOP: no.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 3 mg/mL
- Incubation time: 3 hours (± 5 min)
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 15 minutes exposure is less than 50%.
- The test substance is considered to be non-corrosive to skin if the viability after 15 minutes exposure is greater than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- The test item was applied in its original form, no formulation was required.
- Amount(s) applied (volume or weight with unit): 10 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 20 µL
- Concentration: PBS 1x
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 20 µL
- Concentration: Sodium Dodecyl Sulphate (SDS) 5% - Duration of treatment / exposure:
- 15 min (± 0.5 min)
- Duration of post-treatment incubation (if applicable):
- 42 h (± 1h)
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 / 1
- Value:
- 56
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 / 2
- Value:
- 54
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 / 3
- Value:
- 66
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 59
- Vehicle controls validity:
- not applicable
- 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: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: Prior to routine use of the method TOXI-COOP ZRT. demonstrated the technical proficiency, using the ten Proficiency Chemicals according to OECD Test Guideline No. 439 (data not included).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Table 1. Summary of results.
Substance |
Optical Density (OD) |
Viability (%) |
|
Negative Control: 1 x PBS |
mean |
0,631 |
100 |
standard deviation (SD) |
3,11 |
||
Positive Control: SDS (5%aq.) |
mean |
0,228 |
36 |
standard deviation (SD) |
1,33 |
||
Test Item: IMIDAZOLE ETHANOL |
mean |
0,370 |
59 |
standard deviation (SD) |
6,51 |
Following exposure with the test item, the mean cell viability was 59% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non irritant to skin. In conclusion, in thisin vitro EPISKIN model test with the test item, the results indicate that the test item is non irritant to skin.
The mean OD value of the three negative control tissues was 0.631,
the positive control result showed 36 % viability, each standard
deviation value (SD) of the % viability was below 18 (see table below in
section 9.3). All validity criteria were within acceptable limits and
therefore the study can be considered as valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria.
- Conclusions:
- The test item is not irritant to skin, with a cell viability of 59%.
- Executive summary:
An in vitro skin irritation test of the test item was performed in an EPISKIN-SM reconstructed human epidermis model, according to OECD TG 439 (GLP study). Disks of EPISKIN (3 units / chemical) were treated with test item and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. Epidermis units were then incubated at 37 °C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The precipitated formazan was then extracted using acidified isopropanol and quantified spectrophotometrically. SDS (5% aq.) and PBS treated epidermis were used as positive and negative controls, respectively. All validity criteria were met.
The mean cell viability was 59%, compared to the negative control. Therefore, the test item was not irritating to the skin.
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