Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 213-139-9 | CAS number: 926-63-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Dimethylethylamine in mould core manufaturing: exposure, metabolism, and biological monitoring
- Author:
- Lundh T, Stahlbom B, Akessson B
- Year:
- 1 991
- Bibliographic source:
- Br J Ind Med 48: 203-207
Materials and methods
- Objective of study:
- other: metabolism and excretion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The exposure and metabolism of dimethylethylamine was studied in 12 mould core makers in four different foundries using the Ashland cold box technique.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyldimethylamine
- EC Number:
- 209-940-8
- EC Name:
- Ethyldimethylamine
- Cas Number:
- 598-56-1
- Molecular formula:
- C4H11N
- IUPAC Name:
- N,N-dimethylethanamine
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 10 men and 2 women,
Age: 23-62 years old (mean 38),
working in 4 different foundries.
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The time weight average (TWA) exposure to DMEA was measured in each worker, in his or her personal breathing zone by absorption in impringer flasks during the full work shift (eight hours) divided into about one hour sampling periods.
Workers were exposed to 0.003 - 0.007 mg/L inhaled dimethylethylamine.
The mean TWA full work shift DMEA exposure concentration in the foundries studied was 3.7 (range 0.5-14) mg/m3.
- No. of animals per sex per dose / concentration:
- 10 men and 2 women were studied.
- Control animals:
- other: not applicable
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY
- Tissues and body fluids sampled: urine, blood
Blood samples (20 mL) were collected by venepuncture before the start of exposure, and immediately after the end of exposure.
Urine samples were collected for 24 hours during two periods before the start of exposure, four two hours period during exposure, and six periods after the end of exposure.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- metabolism
- Results:
- Formation of dimethylethylamine-N-oxide
- Type:
- excretion
- Results:
- DMEA and DMEAO excretion in urine
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- none
- Details on distribution in tissues:
- none
- Details on excretion:
- Inhaled dimethylethylamine was excreted in urine as the original amine and as its metabolite dimethylethylamine-N-oxide.
DMEA was readily absorbed and eliminated into urine as DMEA and DMEAO.
After start of exposure, the DMEA and DMEAO excretion in urine increased until the end of exposure, and the decreased again.
The mean DMAEO fraction in the urine was 81% (range 18-93%). In the two women (sisters) studied, DMAEO fractions were considerably lower (18% and 63%) compared with men (84-93%). The data indicate half lives after the end of exposure for DMEA in urine of 1.5 hours.
Toxicokinetic parametersopen allclose all
- Key result
- Test no.:
- #1
- Toxicokinetic parameters:
- other: 0.04 µmol/L DMEA before exposure
- Key result
- Test no.:
- #2
- Toxicokinetic parameters:
- other: 0.21 µmol/L DMEA (postshift)
- Key result
- Test no.:
- #3
- Toxicokinetic parameters:
- other: 0.07 µmol/L DMEAO (before exposure)
- Key result
- Test no.:
- #4
- Toxicokinetic parameters:
- other: 1.8 µmol/L DMEAO (postshift)
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- dimethylethylamine-N-oxide.
Applicant's summary and conclusion
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.
