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EC number: 221-639-3 | CAS number: 3173-53-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.11.2022 - 2.12.2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2023
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- Adopted: 18 June 2019
- Qualifier:
- according to guideline
- Guideline:
- other: OCL-200-EIT-Eye-Irritation-Test-Protocol-MK-24-007-0055_02_02_2021
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cyclohexyl isocyanate
- EC Number:
- 221-639-3
- EC Name:
- Cyclohexyl isocyanate
- Cas Number:
- 3173-53-3
- Molecular formula:
- C7H11NO
- IUPAC Name:
- isocyanatocyclohexane
- Test material form:
- liquid
1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- Test System - the reconstructed human cornea-like epithelial model EpiOcular™ (OCL-200 ver. 2.0). The EpiOcular™ RhCE tissue construct consists of at least 3 viable layers of cells and a non-keratinized surface, showing a cornea-like structure analogous to that found in vivo.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 30 min
- Duration of post- treatment incubation (in vitro):
- - immersion incubation (post-soak) at room temperature - 12 ±2 min
- post-treatment incubation at standard culture conditions - 2 h and 3 min
- incubation with MTT medium at standard culture conditions - 180 min - Number of animals or in vitro replicates:
- A single experiment has been composed of two replicate tissues for the test item, two for negative and two for positive controls.
Results and discussion
In vitro
Results
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- 1 and 2
- Value:
- 7.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The average viability of tissues treated by the test item Cyclohexyl isocyanate was 7.8 % of negative control average value, i.e. viability was < 60 %.
The effect of the test item was positive in EpiOcularTM model (tissues were damaged).
If the test item-treated tissue viability is ≤ 60.0% relative to negative control-treated tissue viability,. - Executive summary:
The test item, Cyclohexyl isocyanate, was assayed for the in vitro eye irritation in human epidermal model EpiOcularTM. The test was performed according to the OECD Test Guideline No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage. Details of the procedure are given in Protocol: EpiOcular™ Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals (MatTek).
MTT test was performed as follows: After pre-incubation and wetting of tissues, 50 µL of the test item was placed directly atop to the moistened tissue and it was spread on the entire tissue surface. Length of exposition was 30 minutes at 37±1°C in humidified CO2 incubator (5±1% CO2). Two tissues were used for the test item and every control.
After removal of the test item, tissues were post-soaked in medium for approximately 12 minutes and post-incubated for 2 hours at culture conditions. Three hours incubation with MTT and 2-3 hours extraction period with shaking followed then. Optical density (OD570) of isopropyl alcohol extracts was measured on a plate reader. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
In the complementary experiments, direct MTT reduction in test tubes was not found. Even the colour of the test item did not interfere with the evaluation of the test. Therefore, the results of the MTT test did not require correction.
Under the above-described experimental design average viability of treated tissues was 7.8 % i.e., viability was ≤ 60 %.
The effect of the test item was positive in EpiOcularTM model (tissues were damaged).
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