A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study; short study description

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

aim of the study was to check whether EDTA can be formed from Keroflux ES 3241 under in vitro conditions (0.1 M HC1, rat plasma or rat liver homogenate).

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide

EC Number:

406-640-0

EC Name:

A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide

Cas Number:

136920-07-5

Molecular formula:

C58H114N4O6 - C154H308N6O4

IUPAC Name:

Reaction mass of 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C12-C18)alkylacetamide and {[2-(Carboxymethyl-di(C12-C18)alkylcarbamoylmethyl-amino)-ethyl]-di(C12-C18)alkylcarbamoylmethyl-amino}-acetic acid

Constituent 2

Reference substance name:

Keroflux ES 3241

IUPAC Name:

Keroflux ES 3241

Details on test material:

Batch No.: (T 75492/ST 1414/90) Partie 1
Manufacturing/Sampling Date: 10.10.1990

Radiolabelling:

no

Test animals

Species:

other: in vitro study

Strain:

other: in vitro study

Administration / exposure

Route of administration:

other: in vitro study

Vehicle:

other: in vitro study

Details on exposure:

in vitro incubation and sample preparation: The test substance (1 mg/ml) was incubated in 0.1 M HCl, rat plasma and rat liver homogenate at 37°C for 4 hours. Samples were drawn immediately after addition of the test substance to the incubation medium (0 h) and after 1, 2 and 4 hours. The samples were extracted twice with n-hexane. Combined hexane phases were used for Keroflux ES 3241 analyses. Aqueous phases were acidified with 1 M acetic acid and centrifuged. After addition of a FeCl3-solution to the supernatant, this solution was taken for EDTA-analyses.

Duration and frequency of treatment / exposure:

up to 4 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
Concentrations for incubation periods of 0, 1, 2 and 4 h, respectively:
Incubation in 0.1 M HCl: 1.03, 1.1, 1.13, 0.97 mg/ml
Incubation in rat plasma: 0.7, 0.8, 0.6, 0.53 mg/ml
Incubation in rat liver homogenate: 0.93, 0,97, 1.17, 0.87 mg/ml

No. of animals per sex per dose / concentration:

in vitro study, number of replicates not reported

Control animals:

other: in vitro study

Results and discussion

Any other information on results incl. tables

Incubation of Keroflux ES 3241 in 0.1 M HCl 1 mg/ml at 37°C for up to 4 hours simulating conditions in the stomach lead to a small decrease of Keroflux ES 3241 concentration in the incubation medium (maximum 6% after 4 hrs of incubation). With respect to the variation of the results at 1 and 2 h, this decrease is not significant. No EDTA could be detected considering a detection limit of about 2 µg/ml.

Incubation of Keroflux ES 3241 in rat plasma at 37°C for up to 4 hours lead to a decrease of Keroflux ES 3241 concentration in the incubation medium by 24 % after 4 hrs of incubation (10% after 2 hrs of incubation). However, no EDTA could be detected above a detection limit of about 2 µg/ml.

Incubation of Keroflux ES 3241 in rat liver homogenate at 37°C for up to 4 hours lead to a small decrease of Keroflux ES 3241 concentration in the incubation medium (maximum 6% after 4 hrs of incubation). With respect to the variation of the results at 1 and 2 h, this decrease is not significant. No EDTA could be detected considering a limit of detection of about 6 µg/ml.