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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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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-06-22 - 2010-09-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline no. 437 and under GLP conditions.
Cross-reference
- 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: OECD Guideline 437: "Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants", 2009
- Principles of method if other than guideline:
- The BCOP (Bovine Corneal Opacity and Permeability) test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. The BCOP test uses isolated corneas from freshly slaughtered cattle. Damage by the test substance is assessed by quantitative measurements of changes in corneal opacity and permeability. Both measurements are used to calculate an in vitro irritancy score (IVIS), which is used to assign an in vitro irritancy hazard classification category for prediction of the in vivo ocular irritation potential of a test substance.
- 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 / tissue source
- Species:
- other: not applicable (this is an in vitro test)
- Strain:
- other: not applicable (this is an in vitro test)
- Details on test animals or tissues and environmental conditions:
- not applicable (this is an in vitro test)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- mean: 289 mg of crinipan were applied
- Duration of treatment / exposure:
- 4 h at 32 °C
- Observation period (in vivo):
- not applicable
Opacity of the corneas is measured at 570 nm, using a spectral photometer.
Permeability is determined by the amount of sodium fluorescein dye that penetrates all corneal cell layers. The fluorescein permeability values are measured as optical density at 490 nm using a spectral photometer. - Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- For the BCOP test with crinipan bovine corneas from freshly slaughtered cattle aged 12 to 60 months were used. The eyes of the cattle were transported from the slaughterhouse within 4 h to the test facility in Hank's balanced salt solution supplemented with 0.01% streptomycin and 0.01% penicillin. The corneas were examined and only corneas which were free from defects were used. The dissected corneas were transferred to a cornea holder and incubated with complete minimum essential medium (cMEM) at 32 ± 1°C for 1 h. After the initial incubation, the medium was changed and the baseline opacity was determined.
The test item crinipan was not soluble in any appropriate solvent for the BCOP test and therefore was used neat. For each treatment group (negative control, positive control, test item) three replicates were used. The test item crinipan was applied directly using a weight board. According to the guideline, the "open chamber method" for non-surface-active solids was performed. Averagely, 0.2893 g of the test item was applied on the epithelium in a way that as much as possible of the cornea was covered with test item. The exposition time on the corneas was 10 min at 32 °C. After thorough rinsing with cMEM a post-incubation time of 2 h at 32 °C followed. Then the opacity value of each cornea was determined and the permeability with sodium fluorescein was measured.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP max. score: 80
- Value:
- 0
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Calculated IVIS:
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control 0,9% NaCl |
1.7605 |
1.1190 |
57.2% |
0.4804 |
|||
1.1165 |
|||
Crinipan AD |
0.5106 |
-0.5610 |
-165.5% |
-1.1023 |
|||
-1.0920 |
|||
Positive Control 20% Imidazole |
74.4592 |
74.4200 |
17.5% |
87.4479 |
|||
61.3534 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It can be stated that in this study and under the experimental conditions reported, climbazole did not exhibit any ocular irritating potential in vitro.
- Executive summary:
The BCOP test was performed to assess the corneal irritation and damage potential of Crinipan AD by quantitative measurements of changes in opacity and permeability in a bovine cornea. The test item Crinipan AD was brought onto the cornea of a bovine eye which previously had been incubated with cMEM ( = complete Minimum essential medium) without Phenol red at 32±1°C for one hour and whose opacity had been determined. The test item was incubated on the cornea for four hours at 32±1°C. After removal of the test item, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control, imidazole (20% solution in 0,9% sodium chloride solution) was used as positive control. The positive control induced severe irritation on the cornea, mean IVIS was 74.42. The negative control showed no irritation, mean IVIS was 1.119. The test item was tested neat. A mean IVIS of -0.561 = 0.00 was calculated, corresponding to a classification as not eye irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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