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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-312-7 | CAS number: 105-59-9
- 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)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- distribution
- excretion
- metabolism
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study to investigate the pharmacokinetics of MDEA following acute intravenous dosing in the rat.
- GLP compliance:
- no
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION
- Radiochemical purity: > 99%
- Specific activity: 1.95 mCi/mmol - Radiolabelling:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc . Indianapolis
- Age at study initiation: 8-10 weeks
- Weight at study initiation: males: 216 g; females: 162 g (average)
- Diet: food and water were available ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled temperature and humidity conditions (not further specified)
- Photoperiod 12 hrs dark / 12 hrs light - Route of administration:
- intravenous
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- single application
- Dose / conc.:
- 50 other: mg/kg bw
- Dose / conc.:
- 500 other: mg/kg bw
- No. of animals per sex per dose / concentration:
- 4 male
- Control animals:
- not specified
- Details on study design:
- The pharmacokinetics and tissue distribution of N-methyldiethanolamine were study in Fischer 344 rats after a single intravenous dose (50 or 500 mg/kg bw).
One day prior to dosing, animals had an indwelling jugular vein cannula implanted by a modification of the method of Harms and Ojeda and then acclimated to individual Roth-type glass metabolism cages. For the intravenous dosing study four male rats per group were given 50 or 500 mg/kg bw [14C] MDEA (10 μCi ) via the cannula at a dose volume of 2 mL/kg, and held for 72 h in metabolism cages.
Urine, feces, and expired 14CO2 were collected at various intervals up to 72 h postdosing from animals held in individual metabolism cages. Blood was collected via the jugular cannula, except for the last sample, which was by cardiac puncture.
The amounts of radioactivity in various samples were measured by liquid scintillation spectrometry. Unchanged MDEA concentrations in the plasma and urine were determined by high-performance liquid chromatography in conjunction with an in-line radioactivity monitor. - Details on distribution in tissues:
- Distribution of MDEA was relatively uniform throughout the major organs, with the highest concentrations being in the liver and kidney.
- Details on excretion:
- The predominant excretion route for MDEA was in the urine. Urinary excretion of MDEA was slow. Metabolites constituted the major fraction in urine, indicating that metabolism plays an important role in MDEA elimination.
- Details on metabolites:
- MDEA was substantially metabolised. Metabolism could be saturated at high dosages since nonlinear kinetic behavior was observed in rats dosed i.v. with 500 mg/kg bw.
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study to investigate the pharmacokinetics of MDEA following acute cutaneous dosing in the rat.
- GLP compliance:
- no
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION
- Radiochemical purity: > 99%
- Specific activity: 1.95 mCi/mmol - Radiolabelling:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc . Indianapolis
- Age at study initiation: 8-10 weeks
- Weight at study initiation: males: 216 g; females: 162 g (average)
- Diet: food and water were available ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled temperature and humidity conditions (not further specified)
- Photoperiod 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Duration of exposure:
- 6 h or 72 h contact
- Doses:
- 500 mg/kg bw
- No. of animals per group:
- 4 male or female
- Details on study design:
- The pharmacokinetics and tissue distribution of N-methyldiethanolamine were study in Fischer 344 rats after a cutaneous dose (500 mg for 6h or 72 h contact).
For the percutaneous dosing study, the interscapular area of the cannulated animals was first clipped free of fur. [14C] MDEA (500 mg/kg, 25 μCi) was applied to a 2 x 4 cm or a 2 x 3 cm area of four males or four females, respectively. The application site was occluded with polyethylene sheeting held in place with adhesive tape and secured with an elastic wrapping bandage. In one group of rats cutaneous contact with the applied dose was maintained for 72 h, while in the the applied dose was removed after 6 hours of contact.
For the cutaneous dosing portions of liver, kidney, bone marrow, spleen, brain, heart, lung, muscle, fat, uterus, and ovaries/testes were collected. Cages were washed, and the wash was collected.
The amounts of radioactivity in various samples were measured by liquid scintillation spectrometry. - Absorption in different matrices:
- Topically applied substance was well absorbed by both male and female rats (17-21% and 41-50% after 6 and 72 h contact respectively), after apparently being the first sequestered in the skin and later slowly released into the bloodstream. Distribution of MDEA was relatively uniform throughout the major organs, with the highest concentrations being in the liver and kidney. The predominant excretion route for MDEA was in the urine. Urinary excretion of MDEA was slow, with an excretion half-life in excess of 30 h following cutaneous dosing.
- Dose:
- 500 mg/kg bw
- Parameter:
- percentage
- Absorption:
- >= 17 - <= 21 %
- Remarks on result:
- other: 6 hours
- Dose:
- 500 mg/kg bw
- Parameter:
- percentage
- Absorption:
- >= 41 - <= 50 %
- Remarks on result:
- other: 72 hours
Referenceopen allclose all
Description of key information
Key value for chemical safety assessment
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 20
- Absorption rate - inhalation (%):
- 100
Additional information
The pharmacokinetics and tissue distribution of MDEA were studied in the Fischer 344 rat after a single intravenous (50 or 500 mg/kg bw) or cutaneous dose (500 mg/kg bw for 6 or 72 h contact; Leung et al, 1996). Topically applied MDEA was well absorbed by both male and female rats (17-21% and 41-50% after 6 and 72 h contact, respectively), after apparently being first sequestered in the skin and later slowly released into the bloodstream. Distribution of MDEA was relatively uniform throughout the major organs, with the highest concentrations being in the liver and kidney. MDEA was substantially metabolised. Metabolism of MDEA could be saturated at high dosages since nonlinear kinetic behavior was observed in rats dosed intravenously with 500 mg/kg bw. The predominant excretion route for MDEA was in the urine. Urinary excretion of MDEA was slow, with an excretion half-life in excess of 30 h following cutaneous dosing. Metabolites (not identified) constituted the major fraction in urine, indicating that metabolism plays an important role in MDEA elimination. Based on these results, a dermal absorption rate of 20% will be used for DNEL derivation. No data on inhalation or oral absorption are available. Therefore, for the DNEL derivation the defaults as reported in the REACH guidance will be used (100% absorption for both routes).
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.