Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
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: well-documented report meeting scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Guideline:
OECD Guideline 417 (Toxicokinetics)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.

Test material

Constituent 1
Reference substance name:
Trilon A
IUPAC Name:
Trilon A
Constituent 2
Reference substance name:
Trisodium nitrilotriacetate
EC Number:
225-768-6
EC Name:
Trisodium nitrilotriacetate
Cas Number:
5064-31-3
IUPAC Name:
trisodium 2,2',2''-nitrilotriacetate
Details on test material:
Trilon A92, Tri-sodium salt of nitrilotri(acetic)acid,
monohydrate, purity 92.4%
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Duration and frequency of treatment / exposure:
see below
Doses / concentrations
Remarks:
Doses / Concentrations:
Either given as single oral dose of 500 or 25 mg/kg or daily for 7 days at a dose of 500 mg/kg
Details on study design:
Investigation on the absorption and excretion of Trilon A92. It was assumed, that the systemically available portion of dose, i.e. the absorbed portion of dose, is exclusively excreted via urine and no metabolism of Trilon A92 occurred. For this reason only urine samples were analyzed for Trilon A92.

Results and discussion

Any other information on results incl. tables

    
At the high dose level of nominally 500 mg/kg bw, animals
actually received an average dose of about 441 mg/kg bw.
Trilon A 92 in urine up to 72 hours after administration
amounted to 40.71 % of the dose applied which assumed to be
equivalent to the bioavailability of Trilon A 92. From the
time course of the amount of Trilon A 92 in urine, the urinary
excretion half-life was calculated to be 6.2 hours.
At the low dose level of nominally 25 mg/kg bw, animals
actually received an average dose of about 22 mg/kg bw.
Trilon A 92 in urine up to 72 hours after administration
amounted to 53.03 % of the dose applied which is assumed to be
equivalent to the bioavailability of Trilon A 92. From the
time course of the amount of Trilon A 92 in urine, the urinary
excretion half-life was calculated to be 4.7 hours.
Animals treated daily for 7 consecutive days with a nominal
dose of 500 mg/kg bw actually received an average daily dose
of about 453 mg/kg bw. During the treatment period and up to
72 hours after the last administration, 47.81 % of the total
dose applied could be found in the urine which is assumed to
be equivalent to the bioavailability. From the time course of
the amount of Trilon A 92 in urine after the last
administration, the urinary excretion half-life was calculated
to be 5.4 hours. The data do not give an indication that
induction or saturation of urinary excretion of Trilon A 92
occurs after repeated oral administration for 7 days.

Applicant's summary and conclusion