Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication/study report which meets basic scientific principles. Justification for read-across see chemical safety report chapter 1.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
A comparison of the elimination and biotransformation of dodecyldimethylamine oxide (DDAO) by rats, rabbits, and man
Author:
Turan T.S. and Gibson W.B.
Year:
1981
Bibliographic source:
Xenobiotica 11, 447-458
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report
Author:
OECD
Year:
2006
Bibliographic source:
OECD Existing Chemicals Database

Materials and methods

Objective of study:
excretion
metabolism
Principles of method if other than guideline:
Excretion and metabolism study in rats after oral application of test substance.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes
Remarks:
C14

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 180 - 230 g
- Fasting period before study: overnight
- Housing: stainless stell cages
- Individual metabolism cages: yes

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration and frequency of treatment / exposure:
single exposure
Doses / concentrations
Remarks:
Doses / Concentrations:
1 and 100 mg/kg
No. of animals per sex per dose:
1 mg/kg: 5 males
100 mg/kg: 2 males, 2 females
Control animals:
no
Positive control:
No
Details on dosing and sampling:
PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, feces, CO2
- Time and frequency of sampling: 24 h intervals for 72 h

Results and discussion

Preliminary studies:
no preliminary study
Main ADME resultsopen allclose all
Type:
excretion
Results:
After 72 h 90 and 98 % of the administered dose were excreted mainly in the urine (54 and 66%).
Type:
metabolism
Results:
No unmetabolized amine oxide was excreted in urine

Toxicokinetic / pharmacokinetic studies

Details on excretion:
After 72 h 90 and 98 % of the administered dose were recovered mainly in the urine (54 and 66%). See table below for details.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
The metabolites identified in this study indicate various metabolizing ways for DDAOs. Urinary metabolites suggest omega-, and beta-oxidation, amine oxide reduction and aliphatic mid-chain hydroxylation.

Any other information on results incl. tables

Percentage of applied radioactivity in excretion products:

Animal

rat(72 h)

 

 

 

dose(mg/kg)

1

100

urine

66

54

feces

7

9

CO2

26

23

carcass

-

4

total

98

90

No unmetabolized amine oxide was excreted in urine

Percentage of applied radioactivity in urine

Species

 

rat

metabolite

Metabolic pathway

 

II

omega-, beta-oxidation

28

metabolite II = carboxylic acid intermediates ofw,B-oxidation, still carrying the amine oxide functional group.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Under the conditions of the test between 90 and 98 % of the dose administerd orally to rats were excreted within 72 h, mainy by urine. Only a metabolized product of the test substance was observed in urine.
Executive summary:

Male and female rats were exposed to 1 and 100 mg/kg test substance orally by gavage. Within 72 h 90 and 98 % of radioactivity was excreted mainly via urine (54 and 66%). No unmetabolized amine oxide was excreted in urine.