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EC number: 638-747-5 | CAS number: 1228186-17-1
- 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
There are no experimental data for DTDMAC available. Read across was
performed to the structural closely related quaternary ammonium compound
dihydrogenated tallowalkylammonium chloride (DHTDMAC, No. 61789 -80 -8)
for which an EU risk assessment exists. To use read-across is justified
not only by structural similarities but also due to comparable
physical-chemical properties like water solubility, log Pow, degree of
unsaturation / saturation, chain length and molecular weight. There is
one valid acute oral toxicity study in rats for assessment purposes
available. The resulting LD50 value is >2000 mg/kg body weight for
DHTDMAC having a comparable chain-length distribution but higher degree
of saturation. A low acute systemic oral toxicity potential of DTDMAC
can be anticipated.
No acute dermal and/or inhalation toxicity study was performed on the
substance due to its corrosive effects to the skin. However, testing of
dihydrogenated tallowalkyldimethyl ammonium chloride (DHTDMAC, CAS No.
107-64-2) for acute dermal systemic toxicity has not revealed any target
organs and/or signs of systemic toxicity. The medium lethal dose (LD50)
was greater than 2000 mg/kg body weight. Additionally, results from an
inhalation study with DHDTMAC revealed an LC50 greater 180 mg/L for a 1
hour exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
There are no studies available for ditallowalkyldimethylammmonium chloride (DTDMAC) with regard to acute systemic toxicity. However, based on the corrosive properties of the substance, waiving of additional acute oral toxicity test on the pure undiluted substance is scientifically justified and the use of read-across for the assessment of the acute toxicity of DTDMAC is appropriate. Clustering quaternary ammonium compounds for assessment purposes was also considered appropriate by the U.S. EPA for registration purposes under FIFRA because of similar toxicological profiles of dialkyldimethylammonium chlorides. Considering the overall toxicity profile of dialkyladimethylammonium compounds it becomes apparent that the toxicological profile of quaternary ammonium compounds is mainly depending on the chain-length distribution and the degree of saturation of the alkyl groups which determine chemical reactivity and that irritative properties are predominating. With regard to DTDMAC read-across to quaternary ammonium compounds having a shorter chain-length distribution with a similar degree of unsaturation on one side and quaternary ammonium compounds having a comparable chain-length distribution but a higher degree of saturation on the other side, should allow scientifically reasonable comparisons and reliable estimates of the toxicity profile of DTDMAC.
A low acute oral toxicity of DTDMAC is supported by results from an acute study with DHTDMAC (CAS No. 92129-33-4) with LD50 greater 2000 mg/kg body weight. No acute dermal toxicity study was performed on the substance due to its corrosive effects to the skin. However, testing of DHTDMAC for acute dermal systemic toxicity according to OECD guideline 402 has not revealed any target organs and/or signs of systemic toxicity. The medium lethal dose (LD50) was greater than 2000 mg/kg body weight.
With regard to acute dermal systemic toxicity, read-across from data on dihaydrogenated tallowalkyldimethylammonium chloride (DHTDMAC, purity approximately 97%) indicate no toxicity potential of concern. Clinical signs of toxicity, macroscipocal visible organ changes and/or mortality was not observed. The median lethal dose (LD50) in an OECD guideline 402 test with DHTDMAC was greater 2000 mg/kg body weight in rats.
An inhalation toxicity study in rats conducted on DHTDMAC has also not provided indications of acute systemic toxicity. The acute LC50 of DHTDMAC was greater than 180 mg/L after a 1 hour exposure period.
Taking read-across into account it is concluded from the available data, that DTDMAC does not represent a significant acute systemic toxic hazard. Because of their closely related structures and similar physico-chemical properties, dialkyldimethylammonium chlorides possess similar human health-related effects and additional testing with DTDMAC is not required. Additional testing of DTDMAC for acute systemic toxicity is also not justified scientifically because of animal welfare reasons. The substance is classified as corrosive to skin and testing for acute toxicity is therefore not needed according to REACH regulation (EC) 1907/2006 (Annex VII, point 8.5, column 2) and risk reduction measures have to apply. Additionally, based on the low vapour pressure of the substance a significant risk concerning inhalation is not anticipated.
Justification for classification or non-classification
Based on all available data on dialkyldimethylammonium chlorides in general, the acute oral toxicity of DTDMAC is considered to be greater than 2000 mg/kg body weight in rats. In accordance with the criteria laid down in Regulation 1272/2008/EC (CLP) the substance is not classified for this endpoint.
No classification is indicated for the other routes of exposure. Taking into account the skin corrosive properties of DTDMAC special attention has to be given to risk management and no additional testing is justified.
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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