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EC number: 211-748-4 | CAS number: 693-33-4
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- Skin sensitisers have been reported to induce genes that are regulated by the antioxidant response element (ARE). The KeratinoSensTM test is a method for which validation studies have been completed followed by an independent peer review conducted by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). The KeratinoSensTM test method was considered scientifically valid to be used as part of an IATA (Integrated Approach to Testing and Assessment), to support the discrimination between skin sensitisers and non-sensitisers for the purpose of hazard classification and labelling. The method cannot be used on its own, neither to sub-categorise skin sensitisers into subcategories 1A and 1B as defined by the UN GHS, for authorities implementing these two optional subcategories, nor to predict potency for safety assessment decisions. However, depending on the regulatory framework a positive result may be used on its own to classify a chemical into UN GHS category 1.
Test material
- Reference substance name:
- (carboxylatomethyl)dodecyldimethylammonium
- EC Number:
- 211-669-5
- EC Name:
- (carboxylatomethyl)dodecyldimethylammonium
- Cas Number:
- 683-10-3
- Molecular formula:
- C16H33NO2
- IUPAC Name:
- 2-[dodecyl(dimethyl)azaniumyl]acetate
- Test material form:
- solid
- Details on test material:
- Chemical Name Lauryl betaine
Physical State liquid - The sample was dried under a nitrogen purge to remove water prior to analysis.
CAS # 683-10-3
EU # 211-669-5
Manufacturer Colonial Chemical
Batch/lot # 53715J16
Received on November 22, 2016
Tested on January 31, 2017
Constituent 1
- Specific details on test material used for the study:
- Test Item Name
ColaTeric LAB-70UP; (1-Dodecanaminium, N-(carboxymethyl)-N,N-dimethyl-, inner salt)
Supplier Code:Not provided
Supplier batch/lot number: 55880C17
CAS number: 683-10-3
Purity: 33.7%
Active Expiry Date: 10 Mar 2019 (from Cofa)
Physical sate: Liquid, clear
Storage Conditions: Standard (10-49˚C, closed container)
Solvent: 1% DMSO in cell culture medium Administration method
In cell culture medium
Concentrations tested (μg/ml)
200, 100, 50, 25, 12.5, 6.25, 3.13, 1.56, 0.78, 0.39, 0.20, 0.10
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: EC1.5 value
- Remarks:
- Luciferase measurements and MTT viability testing were performed. The sensitisation potential of ColaTeric LAB-70UP; was quantified by calculating 2 parameters known as the EC1.5 and the IMAX value.
- Value:
- 9.09
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
The human skin sensitisation potential of ColaTeric LAB-70UP; (Lauryl betaine (C12)) was assessed using validated in vitro method: the KeratinoSensTM test to determine keratinocyte activation. The method was adapted to animal product-free conditions by XCELLR8 and reference chemicals described in the guideline and in the performance standards were used to confirm the reliability, accuracy, sensitivity and specificity values. The adapted method showed full concordance with the Validated Reference Method (VRM) – the KeratinoSensTM standard protocol. Clarification from the European Chemicals Agency (ECHA) says that data using the adapted method may be used in REACH submissions, provided that the Performance Standards data, demonstrating equivalence with the VRM, is included in the dossier.
In this study, ColaTeric LAB-70UP; (Lauryl betaine (C12) was classified as a sensitiser to human skin.
The sensitisation potential of was quantified by calculating 2 parameters known as the EC1.5 and the IMAX value.
Lauryl betaine caused luciferase induction >1.5 in all 3 repetitions. The respective EC1.5 value were calculated as 31.72μg/ml for repetition 1; 61.87 μg/ml for repetition 2 and 9.09μg/ml for repetition 3. Therefore, ColaTeric LAB-70UP; (Lauryl betaine (C12)) was classified as a sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Cetyl betaine is essentially the same molecule as lauryl betaine but with an extra C4 in the alkyl chain so it is likely that the toxicology of the two species will be very similar. Hence, it is assessed that the skin sensitisation response for cetyl would be similar to lauryl.
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