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Diss Factsheets
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EC number: 306-361-3 | CAS number: 97158-31-1
- 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:
- 30/01/2018 until 01/02/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- 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:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- other: MatTek® Human Corneal Epithelium (EpiOcular)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Protocol for solid test articles: approximately 50 mg of test article were applied topically on cultures for 6 hours, followed by a 25-minute post-treatment immersion, and 18-hour post-treatment incubation, prior to the MTT endpoint.
- Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 25-minute post-treatment immersion, and 18-hour post-treatment incubation
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: cell viability [%]
- Remarks:
- relative to negative control
- Value:
- > 60
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Assay Quality Controls
Assay Acceptance Criterion 1: Negative Control (NC)
- Negative Control meets the acceptance criterion.
Assay Acceptance Criterion 2: Positive Control (PC)
- Positive Control meets the acceptance criterion.
Assay acceptance criterion 3: Difference of viability
- The difference of viability between two tissues meets the acceptance criterion.
Tiered test for direct MTT reduction
- The MTT tiered test ensures that there is not direct interaction between the test samples and MTT and therefore corrects against chemicals which might otherwise be falsely predicted as non-irritant. If interaction is observed, the test substances are applied to freeze killed controlled tissue to determine the likelihood of the interaction occurring under test conditions.
- Dimethylbis[2-[(1-oxohexadecyl)oxy]ethyl]ammonium chloride was incubated with MTT for 180 minutes. There was no visual evidence of MTT reduction (violet coloration). Therefore application onto freeze killed tissue was not required.
Colored test chemical
- Colored test chemicals or test chemicals able to develop a color after contact with the tissue can generate a remaining Non-Specific Color on living tissues.
When a colored solution is observed, it is then necessary to evaluate during the future studies the part of OD due to the Non-Specific Color (i.e by using living epidermis tissues without MTT conversion test) to define the %NSCliving value. Nevertheless if the final result classifies the chemical as irritant, it is not necessary to subtract the %NSCliving value.
- Dimethylbis[2-[(1-oxohexadecyl)oxy]ethyl]ammonium chloride was incubated with water and isopropanol for 1hr. There was evidence of white turbidity. Nevertheless, only test chemicals that appear red, blue, black and green should be potentially considered as intrinsic colorants. Dimethylbis[2-[(1-oxohexadecyl)oxy]ethyl]ammonium chloride did not produce colored interference, only white turbidity.
Batch release quality control
- The tissue batch n°27021 met the acceptance criteria defined into the certificate of analysis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dimethylbis[2-[(1-oxohexadecyl)oxy]ethyl]ammonium chloride did not reduce cell viability to below 60% and was classified as non irritant for eyes according to the OECD 492 guideline.
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.
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