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Diss Factsheets
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EC number: 253-775-4 | CAS number: 38083-17-9
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-05-12 to 2010-06-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to EU-Method B.46 " In vitro Skin Irritation: Reconstructed human epidermis model test" (23. July 2009)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: According to Human Skin Model Test EU-Method B.46 adopted 23. July 2009
- Deviations:
- no
- Principles of method if other than guideline:
- The in vitro skin irritation test is used to determine the skin irritancy of chemicals by measuring the cell viability in a reconstructed human epidermis (RhE) model after applying the test substance. The RhE model consists of human-derived epidermal keratinocytes, which have been cultured to form a multilayered model of the human epidermis. Irritant chemicals are identified by their ability to decrease cell viability by quantitatively measuring the enzymatic conversion of the vital dye MTT (3-[4,5-dimethyl thiazole 2-yl] 2,5-diphenyl-tetrazoliumbromide) to a blue formazan salt. Skin irritation potential of the test substance is assessed by reducing the formazan production to less than 50% of the negative control.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Climbazole
- EC Number:
- 253-775-4
- EC Name:
- Climbazole
- Cas Number:
- 38083-17-9
- Molecular formula:
- C15H17ClN2O2
- IUPAC Name:
- 1-(4-chlorophenoxy)-1-(1H-imidazol-1-yl)-3,3-dimethylbutan-2-one
Constituent 1
Test animals
- Species:
- other: not applicable (this is an in vitro test)
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- other: not applicable (this is an in vitro test)
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable (this is an in vitro test)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount of test item: mean: 22.7 mg
- Duration of treatment / exposure:
- 60 min
- Observation period:
- not applicable (cell viability was determined after the end of treatment period)
- Number of animals:
- not applicable (this is an in vitro test)
- Details on study design:
- The human skin model test was performed with commercially available Epi-200-SIT-Kit. The EpiDermTM tissues were produced from MatTek Corporation in Ashland, USA. The day of delivery was the 01. July 2010 batch: 13657
Negative control: Dulbecco’s Phosphate Buffered Saline (DPBS) without CaCl2 and MgCl2
One plate (three tissues) was used as negative control; each tissue was treated with 30 µL DPBS buffer
Positive control: Sodium dodecyl sulphate (SDS), CAS No. 151-21-3, solution in deionised H2O, concentration 50 g/L
One plate (three tissues) was used as positive control; each tissue was treated with 30 µL SDS-solution
Test item: Crinipan AD, ground before use; 22.7 mg for each tissue
One plate (three tissues) was used for treatment with the test item.The tissues were wetted with 25 µL DPBS before applying the test item
Experimental performance:
After dosing the tissues with negative control, positive control and test item, they were incubated at 37 °C for 35 min. After 60 min a rinsing step and two incubation periods at 37°C over a total period of 42 h followed.
After incubation, a MTT assay was performed and formazan production was measured by a spectral photometer at 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60min
- Value:
- 112.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: percentage values of formazan production in comparison to the negative control
- Other effects / acceptance of results:
- not applicable
The mean relative absorbance value was increased to 112.7% after the treatment with Crinipan AD. This value is well above the threshold for irritation (50%). Therefore, the test item is considered not irritant. The mean reduction of the relative absorbance of the positive control was 9.0%.
Any other information on results incl. tables
Comparison of formazan production:
For the test item and the positive control the following percentage values of formazan production were calculated in comparison to the negative control:
% Formazan Production
Designation |
Crinipan AD |
Positive control |
% Formazan production (Tissue 1) |
93.9% |
9.4% |
% Formazan production (Tissue 2) |
130.5% |
7.5% |
% Formazan production (Tissue 3) |
114.4% |
10.3% |
% Formazan production Mean |
112.7% |
9.0% |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance did not show any skin irritation properties in the EpiDerm reconstituted human skin model.
- Executive summary:
This in-vitro study human skin model test (EU method B.46) was performed in order to evaluate the potential of crinipan AD to evoke skin irritation in a human-skin-model. The test item crinipan was spread on the surface of three sections of an EpiDermTM tissue and incubated for 60 min. The negative control consisting of Dulbecco’s phosphate buffered saline was applied to another three tissue sections. As positive control a SDS-solution (50 g/L) was used for three other tissue sections. After rinsing and two incubation steps of altogether 42 h an enzyme assay to determine cell viability was performed. The tissues were incubated with MTT-reagent for 3 h. The tissues were washed with PBS, dried and transferred to a 24 -well-plate. After incubating with isopropanol at room temperature over night, the developed formazan concentration was measured in a spectral photometer at 570 nm.
The mean percentage values of formazan production were calculated in comparison to the negative control. The mean relative absorbance value was increased to 112.7% after the treatment with crinipan. This value is well above the threshold for irritation (50%). The positive control showed a mean reduction of formazan production of 9.0%.
In conclusion, it can be stated that the test item crinipan is considered as non skin irritant under the experimental conditions used in this study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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