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Diss Factsheets
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EC number: 237-860-3 | CAS number: 14024-63-6
- 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
Endpoint summary
Administrative data
Description of key information
The relative mean viability of the test item treated tissues was 105.1 % after the 15-Minute exposure period.
The test item was considered to be Non-lrritant.
Thus a further test on skin corrosion is not deemed to be necessary.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The epidermis surface had previously been moistened with 5 μI of sterile distilled water to improve contact between the solid test item and the epidermis.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Triplicate tissues were treated with the test item
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value
- Value:
- 105.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The relative mean viability of the test item treated tissues was 105.1 % after the 15-Minute exposure period.
The test item was considered to be Non-lrritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Details on test animals or tissues and environmental conditions:
- Triplicate tissues were treated with 30 mg of the test item for 10 minutes. The tissues were dosed at regular timed intervals to allow for the period taken to rinse each insert following exposure and to ensure each tissue received an equal exposure time. The plates were incubated at 37°C, 5% C02 in air during the exposure time.
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg of the test
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- The plates were incubated at 37°C, 5% C02 in air during the exposure time.
- Number of animals or in vitro replicates:
- 3 replicates
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- The optical density was measured (quantitative measurement of tissue viability) at 540nm (00540)
- Value:
- 1.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the study the test item was considered to be an lrritant.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Isolated Rabbit Eye (in vitro)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 0.1 of the test item
- Duration of treatment / exposure:
- 240 minutes
- Duration of post- treatment incubation (in vitro):
- temperature of 32°C ± 1.5°C within the superfusion chamber
- Number of animals or in vitro replicates:
- three enucleated eyes
- Irritation parameter:
- other: Corneal Swelling
- Run / experiment:
- Corneal swelling in % after 240 mins
- Value:
- 9.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following assessment of the data for all endpoints the test item was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
Referenceopen allclose all
Assessment of Eye Irritation Potential - Viability of HCE Tissues
Item | Mean OD540 | Relative Mean Viability (%) |
Negative Control | 0.785 | 100* |
Positive Control | 0.036 | 4.6 |
Test Item | 0.011 | 1.4 |
* The mean viability of the negative control tissues is set at 100%.
The relative mean viability of the test item treated tissues after a 10-Minute exposure period was 1.4%.
Maximal ocular irritation observations recorded for the test eyes were as follows:
Corneal Opacity | Fluorescein Uptake | Corneal Swelling (%) | Condition of Corneal Epithelium | |||||
Test eyes (3 eyes) | Control eyes (2 eyes) | |||||||
0 | 0 | 11.3 | 11.2 | 9.1 | 10.4 | 8.1 | 5.1 | normal |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two in vitro studies were performed on eye irritation.
While the result of the RhCE test would lead to a classification as irritating, the result of the IRE test suggests not to classify the substance.
Based on both test it is concluded that it is extremely unlikely that the substance is eye corrosive as none of the tests give an indication for that classification. Due to that the substance is classified as eye irritating.
Justification for classification or non-classification
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.