Registration Dossier
Registration Dossier
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: 213-156-1 | CAS number: 927-62-8
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dimethylamine
- EC Number:
- 204-697-4
- EC Name:
- Dimethylamine
- Cas Number:
- 124-40-3
- Molecular formula:
- C2H7N
- IUPAC Name:
- N-methylmethanamine
- Test material form:
- other: hydrochloride salt
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- other: rat and mouse
- Strain:
- other: Wistar and CD1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- details are given below
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- details are given below
- Duration and frequency of treatment / exposure:
- details are given below
Doses / concentrations
- Remarks:
- Doses / Concentrations:
details are given below
- No. of animals per sex per dose / concentration:
- details are given below
- Details on dosing and sampling:
- details are given below
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- 1 % of the dose was found in the carcass 3 days after dosing
- Details on excretion:
- Urine was the major route of excretion with the majority of radioactivity (91 %) being voided during the first day. Additional small amounts of radioactivity were observed in the 24-72 h urine (2 %), in faeces (2 %) and in exhaled air (1 %), with a further quantity (1 %) being detected within the carcass after 3 days.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- monomethylamine accounted for 3-4 ± 1-5 (rat) and 4-5 ± 1-3 % (mouse) of the 0-24 h urinary radioactivity.
For comparison: dimethylamine accounted for 96-6 ± 2-5 % /rat) and 95 5 ± 1-3 % (mouse) of the radioactivity in the 0-24 h urine.
Any other information on results incl. tables
Radioactive balance studies
Virtually identical excretory profiles were obtained for rat and mouse following the oral administration of [14C]-dimethylamine. In both rodents, urine was the major route of excretion with the majority of radioactivity (91 %) being voided during the first day. Additional small amounts of radioactivity were observed in the 24-72 h urine (2 %), in faeces (2 %) and in exhaled air (1 %), with a further quantity (1 %) being detected within the carcass after 3 days. Good overall recoveries were achieved, suggesting that only trace amounts of volatile compounds had been exhaled and escaped detection.
Metabolite identification and quantification
In all 0-24 h urine samples examined two radioactive areas were found, which corresponded to authentic methylamine and dimethylamine, but ideal resolution was not always achieved with TLC (Zhang et al. 1994). Reverse-phase paper chromatography of derivatized aliquots of urine revealed the presence of an area of radioactivity (Rf = 0-56), which co-chromatographed with the 2,4-dinitrobenzene derivative of authentic dimethylamine. A separate minor radioactive area (Rf = 0-64), which co-chromatographed with the corresponding derivative of authentic methylamine, was also present in derivatized aliquots of urine. These tentative assignments were confirmed by mass spectrometry. Molecular ions were detected, as expected, at m/z 211 (65 % abundance) and m/z 197 (85 % abundance) corresponding to the 2,4-dinitrobenzene derivatives of dimethylamine and methylamine respectively. The base peak (100 % abundance) for the methylamine derivative corresponded to a fragment ion at m/z 105, which had lost the two nitro groups. Although the corresponding fragment ion was observed for the dimethylamine derivative (m/z 119, 71 % abundance), the base peak occurred at m/z 136 [M-75] +. Other fragment ions were assignable and in agreement with those obtained from synthetic standards and previously published spectra (Stenhagen et al. 1974). Results obtained from the quantification of the two radioactive areas corresponding to the two derivatized amines within the first 0-24 h urine samples showed little variation between the species with 96-6 ± 2-5 and 95 5 ± 1-3 % of the radioactivity being present as dimethylamine in rat and mouse respectively. The demethylation product, methylamine, only accounted for 3-4 ± 1-5 (rat) and 4-5 ± 1-3 % (mouse) of the 0-24 h urinary radioactivity output.
Applicant's summary and conclusion
- Conclusions:
- Radiolabelled dimethylamine was rapidly absorbed after oral gavage and rapidly excreted unchanged in urine. Approx. 5 % of the dose was metabolised to methylamine and excreted via urine. Only 1 % of the dose remained in the carcass 3 days after dosing, i.e. the substance is not persistent and does not accumulate. There was essentially no difference between the rat and the mouse. Based on these results, the test substance has no bioaccumulation potential.
- Executive summary:
The present study suggests that dimethylamine hydrochloride is rapidly absorbed after oral gavage and excreted via the urine. The basic character of dimethylamine (pKa ~ 10-3) should favour its absorption from the more alkaline environments of the gastrointestinal tract and the intestine has been shown to be major site of absorption in rat, with negligible uptake occurring from the acidic environment of the stomach (Ishiwata et al. 1984).
The small amounts of radioactivity detected in the faeces suggests that this low-molecular weight compound is a poor candidate for biliary excretion, as expected and in alignment with previous findings where < 2 % of a dose was found in bile (Ishiwata et al. 1984). Approx. 95 % of the oral dose (radioactivity) was excreted in urine within 24 hours. Only small amounts of the administered radioactivity were excreted with urine thereafter (2 %, during 24-72 hr post dose), in faeces (2 %), and in exhaled air (1 %), with another 1 % being detected in the carcass 3 days after dosing. Good overall recoveries were achieved, suggesting that only trace amounts of volatile compounds had been exhaled and escaped detection.
The radioactivity in urine 0 -24 hr represented almost exclusively dimethylamine (95 %) whereas monomethylamine accounted only for approx. 4 -5 % in rats and mice.
It is concluded that the vast majority of dimethylamine (approx. 95 %) was excreted rapidly unchanged in urine, and that only approx. 5 % of the administered dose was metabolised to either carbon dioxide (exhaled with air, approx. 1 %) or monomethylamine (urine, approx. 4 -5 %). Only 1 % of the dose was found in the carcass 3 days after dosing. Thus, dimethylamine was rapidly and completely excreted (99 % of dose after 3 days), mainly unchanged via urine. Only small amounts (approx. 5 %) were metabolised (dealkylation) and excreted via urine or exhaled air. There were essentially no differences between the rat and mouse (Mitchell et al., 1994).
Additional reference:
Ishiwata H., Iwata R. & Tanimura A. (1984) Absorption, Secretion and Excretion of DMA in rats. IARC, 1984.
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.
