Registration Dossier

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Michaelis constants (Km) and the maximum enzymatic rates (Vmax) are based on reliable experimental results with shorter carbon-chain lactate esters in rat nasal tissue.
Justification for type of information:
Information originates from safety assessments of lactate esters.

Data source

Reference
Reference Type:
review article or handbook
Title:
Safety Assessment of Lactate Esters
Author:
Clary J J, Feron V J and van Velthuijsen J A
Year:
1996
Bibliographic source:
Regulatory Toxicology & Pharmacology 27, 88–97 (1998); Article No. Rt971175

Materials and methods

Objective of study:
toxicokinetics
Principles of method if other than guideline:
Bogaards, J. J. P., and van Ommen, B. (1992). The in vitro hydrolysis L-lactate eaters by rat nasal olfactory epithelium homogenate. TNO Report V92.339.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecyl lactate
EC Number:
228-504-8
EC Name:
Dodecyl lactate
Cas Number:
6283-92-7
Molecular formula:
C15H30O3
IUPAC Name:
dodecyl 2-hydroxypropanoate
Constituent 2
Chemical structure
Reference substance name:
Tetradecyl lactate
EC Number:
215-350-1
EC Name:
Tetradecyl lactate
Cas Number:
1323-03-1
Molecular formula:
C17H34O3
IUPAC Name:
tetradecyl 2-hydroxypropanoate
Test material form:
liquid

Results and discussion

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Toxicokinetic parameters:
other: Km ranges from 0.022 to 0.056 (high affinity)
Toxicokinetic parameters:
other: Average Vmax = 481

Any other information on results incl. tables

Toxicokinetic values Km and Vmax for C12 -C14 lactates:

Lactate

Km

Vmax

dodecyl

0.056

476

tetradecyl

0.030

483

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results Readily hydrolysis with high enzymatic affinity for C12-C15 lactate esters.