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Diss Factsheets
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EC number: 608-174-5 | CAS number: 28183-82-6
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: 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
- Justification for type of information:
- Performed 2018 to GLP using guidelines current at the time
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Purity: 92.5% after removal of water
Physical state/Appearance: Greenish-yellow viscous liquid
Material needed warming to 50 C for ease of handling - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- EPISKIN™ Reconstructed Human Epidermis Model Kit
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 μL (26.3 μL/cm2) of the test item was applied to the epidermis surface without dilution
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- Rinsed tissues were incubated at 37 °C
- Number of replicates:
- Three
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- ca. 91.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean viability of the test item treated tissues was 91.7% after a 15 minute exposure period and 42 hour post-exposure incubation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean cell viability of 91.7% suggested that the material is of low irritancy and classification under CLP is not required.
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
- Justification for type of information:
- 2018 study following guidelines and performed to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Water-free material
Purity: 92.5%
Physical state/Appearance: Greenish-yellow viscous liquid - Species:
- cattle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 ml undiluted added to the chamber with the cornea
- Duration of treatment / exposure:
- Incubated at 32 ± 1 ºC for 10 minutes
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- Three replicates for test material and controls
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- ca. 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Although the study design is more suitable for the Eye Dam 1 and Eye Irrit 2 boundary, the method is validated to accept very low scores as being non-classified for CLP.
The method was chosen as the substance was considered likely to be Eye Irrit 2 based on free amine and reported pH.
The irritation scroe of 2.0 is sufficiently low to conclude non-classification for CLP
Reference
The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7.
The negative control gave opacity of ≤3.0 and permeability ≤0.077.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
In the skin assay, the mean cell viability of 91.7% suggested that the material is of low irritancy and classification under CLP is not required.
For the eye study, it is noted that the study design is more suitable for the Eye Dam 1 and Eye Irrit 2 boundary, although the method is validated to accept very low scores as being non-classified for CLP.
The method was chosen as the substance was considered likely to be Eye Irrit 2 based on free amine and reported pH.
The irritation scroe of 2.0 is sufficiently low to conclude non-classification for CLP
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