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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 08, 2017 to November 10, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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
- Specific details on test material used for the study:
- Identity: Benzyldimethyl(octadecyl)ammonium chloride
Batch no: 15817
Composition: 100%
Cationic activity: 96.2%
Appearance: White solid
Dilution: Not diluted
Expiry date: 09/2019
Storage conditions: Room temperature, protect from humidity and water
In vitro test system
- Test system:
- other: SkinEthic Reconstructed Human Epidermis
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Justification for test system used:
- The SkinEthicTM skin irritation test method is a validated alternative test procedure to the Draize Rabbit Skin irritation Test and endorsed by OECD Guideline 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SkinEthicTM Reconstructed Human Epidermis:
SkinEthicTM Reconstructed Human Epidermis is a three dimensional reconstructed human skin model comprising freshly isolated normal epidermal keratinocytes (NHEK: the major cellular component of skin), which are cultured at the air liquid interface on specialised culture inserts to develop a stratified differentiated epidermis characteristic of skin in vivo. The model consist of multiple layers of viable epithelial cells and a functional multi-layered stratum corneum with robust barrier function.
The SkinEthic skin irritation assay predicts and classifies the skin irritation potential of a chemical by assessment of its cytotoxic effect following its topical application directly to the skin surface and its subsequent penetration through the stratum corneum - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16±2 mg
- Duration of treatment / exposure:
- 42 ± 1 minutes
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 42 minutes exposure
- Value:
- 96.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- (not irritating)
- Conclusions:
- Under study conditions, the test substance was determined to be non-irritant to skin
- Executive summary:
An in vitro study was conducted to determine the skin irritation potential of the test substance, C18 ADBAC (active: 96.2%), using Reconstructed Human Epidermis (RHE) Test Method, according to OECD Test Guideline 439, in compliance with GLP. On Day 18, SkinEhticTM tissues were pre-incubated overnight in the growth culture medium. The tissues were then placed in maintenance culture medium prior to application of the test substance. 10 µL distilled water followed by 16±2 mg of powder was applied to each of the 3 RHE tissue for 42±1 minutes, then rinsed and further incubated, post exposure, for 42±1 h at 37˚C, 5% CO2±1% and 95% humidified atmosphere. Cell viability was quantitatively measured (based on dehydrogenase conversion of the MTT dye (Methylthiazolyldiphenyl-tetrazolium bromide into a blue formazan salt) by determining the absorbance at 570 nm. Sterile Dulbecco’s Phosphate Buffered Saline (DPBS) and sodium dodecyl sulphate (5% in water) were used as negative and positive controls respectively. A test substance is considered to be an irritant to skin if the skin model viability after exposure and post-treatment incubation is ≤50%. The final percentage of viability obtained with the test substance was 96.1%, which was well above the 50% irritant threshold. Optical Density (OD) results obtained with negative and positive controls were within the acceptance limits; hence the study met all the acceptance/validity criteria. Under study conditions, the test substance was determined to be non-irritant to skin (Catoire, 2017).
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