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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.11.2022 - 02.12.2022
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted: 14th June 2021
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Protocol for: EpiocularTM EIT for the prediction of acute ocular irritation of chemicals, October 2, 2019, 1- 47 – Tests for interference of test item with MTT endpoint
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Protocol for: INVITRO EpiDermTM SKIN IRRITATION TEST For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm, Model EPI-200-SIT, Rev. 08/15/2022, 1-35
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µL of the test item
- Duration of treatment / exposure:
- 60 minutes (25 minutes at room temperature and the remaining 35 minutes at culture conditions)
- Number of replicates:
- single experiment, composed of three replicate tissues
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 4.11
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 4.05
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 3.87
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Relative cell viability was calculated for each tissue as % of the mean of the negative control tissues. Then the mean relative tissue viability of three individual tissues exposed to the test item was calculated – this value is used for the comparison with limit given in Chapter 3.8.
Under the above-described experimental design of the MTT test, the average viability of tissues treated with the test item Cyclohexyl isocyanate was 4.0±0.1% of the negative control average value i.e., viability was ≤ 50 %. The positive control, SDS, gave the appropriate response.
The test item colour does not influence study results and the test item does not have direct reductive properties, so any correction of MTT test results was not performed.
The test item effect was positive in the EpiDermTM model i.e., the tissue was damaged.
According to the classification criteria given in chapter 3.9 of this report, the test item, Cyclohexyl isocyanate, is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1 - damage to the skin). - Executive summary:
The test item, Cyclohexyl isocyanate, was assayed for in vitro skin irritation in the human epidermal model EpiDermTM. The main methodical documents were OECD Test Guideline No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (2020), and Protocol for: In Vitro EpiDermTM Skin Irritation Test For use with MatTek Corporation’s Reconstructed Human Epidermal Model EPI-200-SIT.
In the main MTT experiment, after pre-incubation of tissues, 30 µL of the test item was placed directly on the moistened tissue and spread over the entire surface for 60 minutes (25 minutes at room temperature and the remaining 35 minutes at culture conditions). Three tissues were used for the test item and for positive and negative controls.
After removal of the test item, tissues were post-incubated in culture medium for approximately 42 hours. After three hours incubation with MTT, samples were extracted with isopropyl alcohol for 2 -3 hours. Optical density (OD570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
During post-incubation periods, a damage of barrier function was observed in tissues treated by the test item. The appearance of the treated tissues after isopropyl alcohol extraction resembled those affected by positive control.
In the tests for interference of test item with MTT endpoint 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, the average viability of test item-treated tissues was 4.0±0.1%.
The positive control, SDS, gave the appropriate response.
The test item effect was positive in the EpiDermTM model i.e., the tissue was damaged.
According to the classification criteria given in chapter 3.9 of this report, the test item, Cyclohexyl isocyanate, is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1 - damage to the skin).
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