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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication, which meets basic scientific principles.

Data source

Reference
Title:
No information
Author:
Streeter D.G. und Pfadenhauer E.H.: Drug Metabolism and|Disposition, 12, 199-203, (1984)

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
Urinary excretion products derived from [14C]-radiolabelled N,N-dimethylaminoisopropanol were determined following single i.v. and oral administration to rhesus monkeys
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(dimethylamino)propan-2-ol
EC Number:
203-556-4
EC Name:
1-(dimethylamino)propan-2-ol
Cas Number:
108-16-7
Molecular formula:
C5H13NO
IUPAC Name:
1-(dimethylamino)propan-2-ol
Test material form:
liquid
Specific details on test material used for the study:
- namr of test material as cited in the publication: Dimethylaminoisopropanol

SOURCE OF TEST MATERIAL, unlabelled test substance
- Source and lot/batch number of test material: Newport, PharmaceuticalsLot No. 4795-GK- 105.

RADIOLABELLING INFORMATION (if applicable)
- Source: radiolabelled test substance was synthesized by California Bionuclear Corp., Sun VaIley, CA.
- Radiochemical purity: 98%.
- Specific activity: 7.6 mCi/mmol.
- Locations of the label: [3-14C]-labeled NN-dimethylamino-2-propanol.


Radiolabelling:
yes
Remarks:
C14

Test animals

Species:
monkey
Strain:
other:
Remarks:
Rhesus

Administration / exposure

Route of administration:
other: oral and i.v.
Details on exposure:
Six animals were administered by nasogstric intubation, six animals received i.v. doses through an indwelling catheter in the saphenous vein.
Duration and frequency of treatment / exposure:
single administration
No. of animals per sex per dose / concentration:
6 per administration route
Details on dosing and sampling:
- Urine samples were collected continously by an indwelling urinary catheter for 8 hours after administration.In the 12- through 72-hr period, urine samples were collected by means of an urine collection funnel which emptied into collection botles.
- The primary analytical system or metabolite quantification was TLC and autoradiographic analysis.

Results and discussion

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
A single metabolite derived from [14C]-radiolabelled N,N-dimethylaminoisopropanol was identified as N,N-dimethylaminoisopropanol-N-oxide.
This Metabolite accounted for 17 - 18% of the administrated radioactivity in either the i.v. or orally dosed animals.
48% (i.v.) nd 55% (oral) of the total radioactivity were assigned to the parent compound.
The proportions of dimethylaminoisopropanol-N-oxide and dimethylaminoisopropanol appeared to be unaffected by route of administration, with the parent compound dominating in both cases.

Applicant's summary and conclusion

Conclusions:
Dimethylaminoisopropanol is mostly excreted as the original substance after i.v. and oral administration to the rhesus monkey. The only observed metabolite is dimethylaminoisopropanol-N-oxide.