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Diss Factsheets
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EC number: 700-414-8 | CAS number: 23328-71-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Local lymph node assay (LLNA) is known to cause false-positive result.
Both negative1) and positive2) results are reported on “quaternary ammonium compounds, benzyl-C12-16 -alkyldimethyl, chlorides” in LLNA, but this “quaternary ammonium compound” is reported as negative in Guinea Pig Maximization Test3). The result is different by each test.
The result of LLNA on 3-octadecyloxypropyl -N,N,N-trimethylammonium chloride, which was proceeded for this registration, was positive, but negative result was confirmed in Guinea Pig Maximisation Test (report is submitted also) using equivalent 3-octadecyloxypropyl -N,N,N-trimethylammonium chloride.
Considering all the above-mentioned results, 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride seems to be negative in skin sensitisation.
1) D. A. Basketter, et al, Food and Chemical toxicology 36, 327-333 (1998)
2) D. A. Basketter, et al, Food and Chemical toxicology 34, 985-997 (1996)
3) The Murine Local Lymph Nod Assay:A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/Compounds, Appendix A-3, NIH Publication No.99-4494
Migrated from Short description of key information:
There are 2 study ebdpoint records for sensitisation. The test material for both studies is the same as the reference substance.
The key study (guinea pig maximisation test (GPMT), reliability of 1) did not show any evidence of reactions indicative of skin sensitisation to the test material under the test condition. The concentrations used in the study were 10% as induction concentration and 0.5, 0.3, 0.1, 0.05, 0.03 and 0.01% as challenge concentrations. The test material is considered to be a non-sensitiser in this condition and does not meet the criteria for classification according to the EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
However, the supporting study (mouse local lymph node assay (LLNA), realiability of 1) showed that the test material was considered to be a sensitiser under the test condition. The concentrations used in the study were 25%, 10% or 5% w/w. Therefore, the test material is classified as R43 May cause sensitisation by skin contact under Council Directive 67/548/EEC and Category 1 under Regulation (EC) No 1272/2008.
Due to the false-positive result of LLNA reported in other substance, 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride seems to be negative in skin sensitisation.
Justification for classification or non-classification
The result of GPMT is more relevant to be used for the classification and labelling of this endpoint. Therefore, the notified substance is not classified for this endpoint under EU classification system.
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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