Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 850-698-3 | CAS number: 2387913-24-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.11.2019 - 11.04.2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate
- EC Number:
- 850-698-3
- Cas Number:
- 2387913-24-6
- Molecular formula:
- not applicable
- IUPAC Name:
- N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate
- Test material form:
- other: solified melt
- Details on test material:
- - Name of test material ((as cited in study report):
Product name: V10069,
Systemic name: Quaternary ammonium compounds, tri-C8-10-alkylmethyl-methylsulfate
Constituent 1
Test animals
- Species:
- other: EpiDerm™ (EPI-200-SCT, Lot no. 25899) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.
- Details on test animals or test system and environmental conditions:
- EpiDerm™ is cultured from normal human keratinocytes.
Test system
- Amount / concentration applied:
- 25 mg of test item were applied topically to the centre of the skin equivalent with a surface area of 0.63 cm2 by using a sharp spoon to uniformly cover the skin surface. The test item is a fine powder. For better contact of the test item to the skin, the skin surface was moistened with 25 μL sterile deionised water to ensure adequate contact with the skin.
- Duration of treatment / exposure:
- Quality control (Triton X-100, 1 % solution)
Positive control 3 min + 60 min (± 1 min) (8 N KOH)
Negative control 3 min + 60 min (± 1 min) (sterile deionised water)
Test substance 3 min + 60 min (± 1 min) undiluted - Number of animals:
- The test was performed in duplicate.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Exposure: 3 min
- Value:
- ca. 79.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure: 60 min
- Value:
- ca. 65.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Exposure 3 min:
Test substance: mean viability 79.4 %
Negative control: mean viability 100 %
Positive control: mean viability 6.6 %
Exposure 60 min:
Test substance: mean viability 65.3 %
Negative control: mean viability 100 %
Positive control: mean viability 6.4 %
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (duplicate)
resulted in a mean cell viability of 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure) when compared to the corresponding negative conrol. Under the present test conditions Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin. - Executive summary:
The purpose of this study was to determine cytotoxic properties of Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates to skin cells, which might lead to human skin corrosion, by using an artificial three-dimensional model of human skin. The EpiDermTM model was employed.
Duplicate tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed
as relative percentage of viability of the negative control-treated tissues.
25 mg of test item were applied topically to the centre of the skin equivalent with a surface area of 0.63 cm2 by using a sharp spoon to uniformly cover the skin surface. The test item is a fine powder. For better contact of the test item to the skin, the skin surface was moistened with 25 μL sterile deionised water to ensure adequate contact with the skin. Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference item. An exposure time of 3 min and 60 minutes was employed.
The mean viability of cells exposed to Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates was 79.4% (after 3 min exposure) and 65.3% (after 60 min exposure) of the negative controls and, hence, was above the cut-off percentage cell viability value that distinguishes corrosive from non-corrosive test items of > = 50%. Under the present test conditions Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.
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.