Tetraethylammonium heptadecafluorooctanesulphonate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Objective of study:

toxicokinetics

Principles of method if other than guideline:

Rats received single oral dose of FC-95-14C (mean dose, 4.2 mg/kg) in solution. Groups of three rats were sacrificed by exsanguination at 1, 2, 6, 12, 24, 48, 96, and 144 hours post dose. In addition to plasma and red blood cells, total urine, total feces, spleen, digestive tract plus contents (esophagus, stomach, small intestine, large intestine, and colon), and remainder of carcass were saved from each of the three rats in the 24 and 48 hours post dose groups for carbon-14 analysis.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Potassium heptadecafluorooctane-1-sulphonate

EC Number:

220-527-1

EC Name:

Potassium heptadecafluorooctane-1-sulphonate

Cas Number:

2795-39-3

IUPAC Name:

potassium 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane-1-sulfonate

Details on test material:

Identity: Potassium perfluorooctylsulfonate, CAS 2795-39-3
Remarks: FC-95-14C (carbon-14 label alpha to sulfur atom, Riker Isotope Inventory Number 442). The specific activity is 0.459 +- 0.008 uCi/mg. Thin-layer and column chromatography showed the FC-95-14C to be at least 99% radiochemically pure. The FC-95-14C was found to be suitable for metabolism studies.

Radiolabelling:

yes

Test animals

Species:

rat

Strain:

other: Charles River CD

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.9% NaCL solution containing 1.2 mg FC-95-14C/2.0 ml

Duration and frequency of treatment / exposure:

single dose

Doses / concentrations

Remarks:

Doses / Concentrations:
4.2 mg/kg average

No. of animals per sex per dose / concentration:

Number of animals/sex/dose: 24

Control animals:

no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

After a single oral dose of FC-95-14C (mean dose, 4.2 mg/kg) in solution to groups of three male rats, at least 95% of the total carbon-14 is systemically absorbed at 24 hours. The half-life for elimination of total carbon-14 from plasma is 7.5 days.

Details on distribution in tissues:

The digestive tract and contents contained on the average, 3.45% of the dose. The mean fecal excretion is 1.55% of the dose at 24 hours and 3.24% at 48 hours. At 24 hours, the mean sum of total carbon-14 in feces and digestive tract plus contents is 5% of the dose. Some of this 5% likely represents systemically absorbed carbon-14 present either in the digestive tract tissues or in the digestive tract contents as a result of excretion. The data from the 48 hour post dose group of rats are consistent with the 24 hour post dose data. Thus, at least 95% of the FC-95-14C dose was absorbed from solution after administration to nonfasted rats. The major portion of the radioactivity recovered was found in the carcass. The carcass data are not as reliable as the other tissue data since large volume homogenates were necessary and homogeneity of sample aliquots was difficult to assure. There is some excretion of total carbon-14 in urine (1-2%/day). The spleens from the 24 hour and 48 hour post dose rats were analyzed for total carbon-14 content, and the percent of the dose in the whole organ was ~0.2%. The concentrations of total carbon-14 in red blood cells
and plasma were compared. The mean ratio of red blood cell to plasma concentration at 24 and 48 hours is 0.25 and 0.39, respectively. Thus, at 24 and 48 hours after a single oral dose of FC-95-14C, there is no selective retention of carbon-14 in red blood cells.

Details on excretion:

The half-life of elimination from plasma was determined by analysis of plasma samples from groups of three rats at 1, 2, 6, 12, 24, 48, 96, and 144 hours after a single oral dose of FC-95-14C. The log of mean concentration versus time for these data was plotted. The least squares line through the individual points from 24 to 144 hours for these data fits the equation: Cp = 15.65e^(-0.00387t) where Cp is plasma concentration. The half-life of elimination from plasma is 179 hours (7.5 days). Thus, elimination from plasma of total carbon-14 after a single oral dose of FC-95-14C is slow.

Toxicokinetic parameters

Toxicokinetic parameters:

half-life 1st: 7.5 h from plasma

Metabolite characterisation studies

Metabolites identified:

not measured

Details on metabolites:

no data

Any other information on results incl. tables

Excretion routes, body fluids, and tissues monitored and/or sampled during study:

red blood cells, plasma, urine, feces, spleen, digestive tract plus contents (esophagus, stomach, small intestine, large intestine, and colon), and carcass

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): high bioaccumulation potential based on study results

Executive summary:

Rats received single oral dose of FC-95-14C (mean dose, 4.2 mg/kg) in solution. Groups of three rats were sacrificed by exsanguination at 1, 2, 6, 12, 24, 48, 96, and 144 hours post dose. In addition to plasma and red blood cells, total urine, total feces, spleen, digestive tract plus contents (esophagus, stomach, small intestine, large intestine, and colon), and remainder of carcass were saved from each of the three rats in the 24 and 48 hours post dose groups for carbon-14 analysis.

The half-life of elimination from plasma is 179 hours (7.5 days). Thus, elimination from plasma of total carbon-14 after a single oral dose of FC-95-14C is slow.