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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 471-920-1 | CAS number: -
- 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
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Toxicokinetic assessment of the substance
The toxicokinetic profile of the substance was not determined by actual absorption, distribution, metabolism or excretion measurements. Rather, the physical chemical properties of the new substance, the data obtained from acute and repeated-dose toxicity studies, as well as information gained from genotoxicity assays are used to create a predicted model of toxicokinetic behavior.
The substance is a N, N-didodecylglycolamide with an average molecular weight of 448 gm/mol. The new substance is poorly water soluble (<1.6 x 10-3gm/L), with a relative high octanol/water partition coefficient (log Ko/w> 6), and a very low vapor pressure (2.3 x 10-8Pa @ 25oC).
Absorption
The physical chemical properties highlighted above suggest that the substance
is of adequate molecular size to participate in endogenous absorption mechanisms within the mammalian gastrointestinal tract should that material be ingested. Being highly lipophilic (log Ko/w> 6), the substance is expected to readily across gastrointestinal epithelial barriers, and may also participate in micellar transport into the hepatic portal system along with other lipophilic substances (e.g., dietary fats). Yet, acute and repeated-dose oral gavage toxicity studies identified little evidence of toxicity (LD50 > 2000 mg/kg and NOEL = 1000 mg/kg/day, respectively). The lack of adverse findings following oral dosing may be due to limited gastrointestinal absorption of the test material after dosing, or a very low index of inherent toxicity for this substance, and/or its metabolite(s).
The substance was also tested for acute toxicity following dermal application. Once again, single-dose dermal application of the test material resulted in no manifestations of systemic toxicity that would suggest systemic absorption through cutaneous barriers.
The potential for inhalation toxicity was not measured for this new chemical notification. However, the substance vapor pressure indicates a very low propensity to enter atmospheric air in a respirable form. Thus, respiratory absorption under normal use and handling of this material is expected to be inconsequential.
Distribution
Systemic distribution of the substance can be predicted from the physical chemical properties of this substance. The relatively high log Ko/wand poor water solubility suggests that this substance, upon systemic absorption, may be transported through the circulatory system in association with a carrier molecule such as a lipoprotein or other macromolecule. The lipophilic character and molecular size of the substance suggests that the molecule will readily traverse cellular barriers and potentially distribute into fatty tissues. There is no evidence from repeated dose studies of cumulative toxicity as would be manifested by an accumulation of the substance or metabolites in tissues.
Metabolism
The substance (N,N-dicoco-alkyl-2-hydroxyacetamide) contains a terminal hydroxyl group, a carbonyl and a tertiary amide group. These types of moieties are recognized to undergo phase I oxidation/reduction and subsequent Phase II conjugation. Acute and repeated-dose toxicity testing provided no evidence that The substance is being transformed to toxic metabolites. Data from mutagenicity and chromosomal aberration testing in which the substance was subjected to phenobarbitone-induced rat hepatic microsomal enzyme systems revealed no evidence of genotoxic activity, suggesting that the metabolic by-products are relatively innocuous. It is possible that the substance undergoes cutaneous metabolic transformation as well.
Excretion
The structural characteristics of the substance suggest that this molecule will readily undergo phase I and phase II metabolic transformation. The resulting metabolic by-products are expected to undergo routine renal and or biliary excretion.
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.