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EC number: 700-421-6 | CAS number: 1215122-81-8
- 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
Skin irritation/corrosion:
-rabbit (C12DMA), key: corrosive
-rabbit (C12DMA), key: irritating
-rabbit (C14DMA), key: irritating
-rabbit (C14DMA), key: irritating
-rabbit (C16DMA), key: corrosive
-rabbit (C16DMA), non-key: irritating
-rabbit (C16DMA), non-key: corrosive
-rabbit (C12-14DMA), key: corrosive
-rabbit (C12-14DMA), key: corrosive
-rabbit (C12-14DMA), key: corrosive
-in-vitro OECD431 (C12-14DMA): not corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), key: corrosive
-rabbit (C12-18DMA), non-key: no severe damage
-rabbit (C12-18DMA), non-key: severe damage
-rabbit (C16-18DMA): corrosive
-rabbit (C16-18DMA): corrosive
-in-vitro OECD431 (C16-18DMA), non-key: non-corrosive
-rabbit (18DMA), key: irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There is no experimental data on skin/eye irritation/corrosion for N,N-dimethyl-C12-16-(even numbered)-alkyl-1-amines, lactates. The acute toxicity of the registration substance is derived from the available data of dimethyl alkylamines (DMAs) with comparable length of alkyl chain (source substances).
Clear skin corrosive effects was observed in in-vivo studies in rabbit with both C12DMA, C16DMA, C12 -14DMA, C12 -18DMA, and C16 -18DMA. Although in some in-vivo and in-vitro studies, only irritating or non-corrosive effects are indicated, DMA is considered to be corrosive to skin, based on the "worst case" scenario. Based on the available data the substance is classified as Category 1B for skin irritation/corrosion, according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
According to EU regulation 1907/2006, Annex VII, column 2, the study regarding eye irritation needs not to be conducted since the substance is classified as corrosive to the skin.
The analogue approach using dimethyl alkylamines (DMAs) with comparable length of alkyl chain as source chemicals is justified:
The target chemical Amines, C12-16-alkyldimethyl, lactates is an ionic compound that results from the neutralization reaction of the compounds of lactic acid and C12-16-DMA. In aqueous solution or in a biological fluid, it could be dissociate as lactic acid and C12-16-DMA. Therefore, the toxicity toxicological profile of the target chemical should be comparable to that of C12-16-DMA and lactic acid. Lactic acid is a natural, functional metabolite in mammals, and serves as mammalian fuel. From previous investigations, it is concluded that lactic acid does not present a hazard for the human health based on its low hazard profile. Based on the basic concept of “chain length category”, the use of toxicity data of other dimethyl alkylamines with comparable length of alkyl chain for read-across purpose to C12-16-DMA and the target chemical is justified. The dissociated product of the target chemical – C12-16-DMA and the source chemicals of C12-DMA, C14-DMA, C16-DMA, C18-DMA, C12-14-DMA, C12-16-DMA, C12-18-DMA and C16-18-DMA belong to the homologues series of fatty amines and form a “chain length category”, where there is an incremental increase in the number of CH2 units. Therefore, it can be reasonably assumed that C12-16-DMA and other dimethyl alkylamines (C12-DMA, C14-DMA, C16-DMA, C18-DMA, C12-14-DMA, C12-16-DMA, C12-18-DMA and C16-18-DMA) share the same toxic mode of action.
The major available physic-chemical properties of target and source chemicals are in a comparable range and support hypothesis that the source and the target chemicals behave similarly or as a function of carbon chain length.
All the chemicals are assessed using the rule based expert system DEREK Nexus based on their chemical structures. The assessment results are identical for the target chemical and source chemicals: all the chemicals are predicted as negative for mutagenicity in bacteria. No toxicity potential or structure alert is identified.
With regard to the endpoint of skin irritation/corrosion, corrosive effect was identified for the source chemicals of C12-DMA, C16-DMA, C12-14-DMA, C12-18-DMA and C16-18-DMA. The target chemical is considered as corrosive to skin (Cat 1B) based on the analogue approach. For this endpoint, the analogue approach is also justified considering the “worst case” scenario.
Based on these similarities in structural, functional and metabolic behavior of DMAs and DMA lactates, it is therefore reasonable and scientifically justified to use analogue DMAs as source molecules to inform endpoint related data gaps for the target molecule under discussion.
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Based on the available data the substance is classified as Category 1B for skin irritation/corrosion, according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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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