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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Objective of study:
other: Biopersistence Screening
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The potential for the test substance, when administered by gavage, to be absorbed and to accumulate in a mammalian system was examined.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-octane-1-sulfonic acid
Cas Number:
913252-35-4
IUPAC Name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-octane-1-sulfonic acid
Test material form:
solid: particulate/powder
Details on test material:
- Purity: 100%

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Details on species / strain selection:
The Crl:CD(SD) rat was selected based on consistently acceptable health status and on extensive experience with this strain at the test facility.
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Duration and frequency of treatment / exposure:
Daily for 10 days
Doses / concentrations
Dose / conc.:
25 mg/kg bw/day (nominal)
No. of animals per sex per dose / concentration:
10 male animals
Control animals:
yes
other: Deionized water
Positive control reference chemical:
Potassium perfluoroalkyl sulfonate (10 mg/kg/day) and Octanoic acid, pentadecafluoro-, ammonium salt (20 mg/kg/day)
Statistics:
Descriptive statistics (e.g. mean, standard deviation) were used.

Results and discussion

Preliminary studies:
In the rangefinding study, 5 male rats were dosed with test substance by oral gavage at a dosage of 1000 mg/kg. The study was terminated after 3 days of dosing because the animals experienced body weight losses of up to 13%. The study conducted at 200 mg/kg/day was also terminated after 6 days of dosing because of body weight losses of up to 19% in the rats. The dosage of 25 mg/kg/day was selected for the main study and was expected to produce minimal body weight loss or toxicity.
Main ADME resultsopen allclose all
Type:
absorption
Results:
The Cmax for test substance was 95 μM equivalents.
Type:
absorption
Results:
The AUCINF/D for test substance was 17,865
Type:
other:
Results:
The total fluorine concentration in the livers from rats dosed with test substance was 423.64 μM equivalents at day 10 and 8.95 μM equivalents at day 94
Type:
other:
Results:
The total fluorine concentration in the fat from rats dosed with test substance was 8.07 μM equivalents at day 10.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The test substance normalized μM equivalents in rat increased during the dosing period and did not appear to reach steady-state. The Cmax for test substance was 95 μM equivalents. The total internal exposure resulting from a normalized dose was described by AUCINF/D and was the basis for comparison between test substance and the positive controls. The AUCINF/D for test substance was 17865 as compared to AUCINF/D values of 522474 and 81507 for the postive controls, respectively
Toxicokinetic parametersopen allclose all
Key result
Toxicokinetic parameters:
Cmax: 95 μM equivalents
Key result
Toxicokinetic parameters:
AUC: 17865
Remarks:
Dose-adjusted areas under the curve

Any other information on results incl. tables

The mean relative liver weight (liver/body weight) of rats dosed with the test substance was 12% higher than the negative control weight at day 10 and 6% higher at day 94. The mean relative liver weight of rats dosed with one of the positive controls was 23% higher at day 10 than the liver weight of rats dosed with the test substance. By day 94, the weights were the same. Therefore, the relative liver weights of rats dosed with the test substance were somewhat affected.

Applicant's summary and conclusion

Conclusions:
Absorption of test substance by rats following oral gavage administration was evident based on quantification of fluorine in the blood, liver, and fat. A very minimal increase in relative liver weight was observed for test substance. Fluorine concentrations and the AUCINF/D were significantly lower than those in rats dosed with the positive control materials.
Executive summary:

The study was conducted to evaluate the potential for test substance, when administered by gavage, to be absorbed and to accumulate in a mammalian system. Specific experimental endpoints included clinical signs, body weights, liver weights, and total fluorine concentrations in blood, fat and liver. Two groups of 5 male Crl:CD(SD) rats each were exposed to 25 mg/kg/day of test substance for 10 consecutive days. Blood was collected from the orbital sinus of 5 rats approximately 2 hours after dosing on test days 1 and 5. Approximately 2 hours after the last dose, these rats were euthanized and blood, livers and fat were collected. Blood was collected from the orbital sinus of the remaining 5 rats on test days 13, 24, and 52. These rats were euthanized on test day 94 and blood, livers and fat were collected. Body weights and clinical signs were recorded on each day of dosing and then weekly during the recovery period. A negative control, deionized water, and 2 positive controls were tested as described for test substance.

No test substance-related clinical signs or body weight effects were observed. Liver weights were somewhat affected in rats dosed with the test substance. The increased relative liver weights appeared to be associated with increased concentrations of fluorine containing test or positive control substances, particularly at Day 10. Steady-state for fluorine in the blood was not achieved during the 10-day dosing period with the test substance. Dose adjusted areas under the curve (AUCINF/D) for positive controls were approximately 29-fold and 5-fold higher than the AUCINF/D for the test substance. Under the conditions of this study absorption of test substance by rats following oral gavage administration was evident based on quantification of fluorine in the blood, liver, and fat. A very minimal increase in relative liver weight was observed for the test substance. Changes in relative liver weights were greater for the positive controls, and were associated with greater concentrations of fluorine in the liver particularly at Day 10. The tissue concentrations declined after cessation of dosing with some retention of fluorine in the blood and liver based on quantification on the end of the study. However, fluorine concentrations and the AUCINF/D were significantly lower than those in rats dosed with the positive control materials.