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Diss Factsheets
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EC number: 204-527-9 | CAS number: 122-19-0
- 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:
- From January 30, 2018 to Febraury 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:
- Adopted october 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzyldimethyl(octadecyl)ammonium chloride
- EC Number:
- 204-527-9
- EC Name:
- Benzyldimethyl(octadecyl)ammonium chloride
- Cas Number:
- 122-19-0
- Molecular formula:
- C27H50N.Cl
- IUPAC Name:
- .
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: human-derived keratinocytes
- Details on test animals or tissues and environmental conditions:
- The EpiOcular tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcularTM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. The tissue surface is 0.6 cm2.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 6 h
- Duration of post- treatment incubation (in vitro):
- 18 h
- Number of animals or in vitro replicates:
- Duplicates
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % relative tissue viability
- Run / experiment:
- 6 h
- Value:
- 5.7
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
% Viability positive control and test substance:
Treatment | Acceptance criterion | OD570nm | Viability % | Difference of viability | % Mean viability |
Water (NC) | 0.8≤OD≤2.5 | 1.653 | 100.3 | 0.5 | 100 |
Difference of viability <20% | 1.644 | 99.7 | |||
Methyl acetate | %mean viability < 50% | 0.173 | 10.5 | 13.2 | 17.1 |
Difference of viability <20% | 0.391 | 23.7 | |||
Test substance | Difference of viability <20% | 0.136 | 8.2 | 5.2 | 5.7 |
0.051 | 3.1 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met (Inconclusive)
- Conclusions:
- Under the conditions of the study, the test substance can be considered to be potentially irritating, however no prediction for classification (i.e., GHS class 1 and GHS class 2) can be made
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance, C18 ADBAC (active: 96.2%), using the commercially available MatTek® Human Corneal Epithelium (EpiOcular) test method, according to OECD 492 Guideline, in compliance with GLP.EpiOcularTM tissues were placed in 1 mL of fresh maintenance medium (6-well plate). The tissues were incubated overnight at 37°C, 5% CO2, in humidified incubator and after 1 h, the medium was replaced by 1 mL of fresh medium for an overnight incubation at at 37°C, 5% CO2, in humidified incubator. The tissues in duplicate were exposed to single topical application of 50 mg neat test substance or 50 µL of reference substances (negative control: sterile water; positive control: methyl acetate) for 6 h, followed by a 25 minutes post-treatment immersion, and 18 h post-treatment incubation, prior to the MTT endpoint. After different treatment exposure period, tissues were transferred to 24 well plates containing MTT medium (1 mg/mL). After 3 h MTT incubation, the blue formazan salt formed was extracted with 2 mL of isopropanol per tissues for 2 to 3 h at room temperature or overnight at 4°C. The absorbance of the resulting coloured solution was measured at 570 nm. The viability of the tissues (which has been shown to directly correlate with the irritation potential) were assessed and compared to a negative control. The percentage viability obtained with the test substance was determined to be 5.7%, which is well below the threshold (i.e., ≤60%) indicating no prediction can be made. All the assay acceptance criteria were met and the study was considered valid. Under the conditions of the study, the test substance can be considered to be potentially irritating, however no prediction for classification (i.e., GHS class 1 and GHS class 2) can be made (Catoire, 2018).
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