Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 June 2012 - 11 July 2012
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 305.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate
EC Number:
Molecular formula:
sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate
Test material form:
other: waxy solid

Sampling and analysis

Details on sampling:
- Sampling intervals/frequency for test organisms: days: -2, -1, 0, 2, 7, 14, 16, 19, 20, 22, 26, 28
- Sampling intervals/frequency for test medium samples: days: -2, -1, 0, 2, 7, 14, 16, 19, 20, 22, 26, 28
- Sample storage conditions before analysis: @-18 °C until analysis, if necessary
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):
Lipid analysis:
The lipid content of the fish was determined at the start and at the end of the study, from 2 fish per test concentration and 1 fish from the control group, respectively. Since recoveries of the test item in fish on day 28 indicated that a depuration phase could be waived no depuration phase was carried out. The samples for lipid analysis in fish were taken at day 28 (test end). The lipid content was determined gravimetrically by extraction with n-hexane. The lipid content of the food was provided by the manufacturer: 15 % (raw fat).

Test solutions

Details on preparation of test solutions, spiked fish food or sediment:
The stock solution was prepared with dem ineralised water, treated one minute with ultrasonic and stirred for 48 hours at 35 °C.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
- Common name: Rainbow trout
- Strain:
- Source: Forellenzucht Harkenbieck, Steinbrink 41, 30966 Hemmingen, Germany
- Age at study initiation (mean and range, SD): 26 weeks
- Length at study initiation (lenght definition, mean, range and SD): 8 +/- 4 cm
- Weight at study initiation (mean and range, SD):
- Weight at termination (mean and range, SD):
- Method of breeding:
- Health status: ok
- Description of housing/holding area:
Holding was performed at the test facility at 13 - 17°C, diffuse light (0.1 - 10µmol•m^-2 •s^-1, diurnal light with 16 h light / 8 h dark) and under flow-through conditions. The dissolved oxygen concentration was more than 80 % of the air saturation value. Only rainbow trout from a pool with at least 12 days of acclimation and mortality< 5 % within the last 7 days before the study started were used in the test. The fish have been treated with eSHa 2000® und eSHa ExitTM (Esha GmbH) after arrival for 24 hours. The stock population was fed the same type of food to be used during the test.

- Feeding during test YES
- Food type: Forellenzuchtfutter 0.8-1.2 mm (Teichcenter Rieger)
- Amount: 1.5% of the initial fish weight
- Frequency: on working days

- Acclimation period: at least 12 days
- Acclimation conditions (same as test or not): YES
- Type and amount of food: same as test
- Feeding frequency: same as test
- Health during acclimation (any mortality observed): no mortality

Study design

Route of exposure:
Test type:
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
28 d
Total depuration duration:
0 d

Test conditions

10 - 250 mg CaC03 / L
Test temperature:
15 +/- 2
6 - 8.5
Dissolved oxygen:
not less than 60%
Details on test conditions:
- Test vessel: 120 L open
- Type of flow-through (e.g. peristaltic or proportional diluter): continous flow through maintained by membrane piston pump
- Renewal rate of test solution (frequency/flow rate): 25 L/h
- No. of organisms per vessel: 40 per group (control group, test group)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
- Biomass loading rate: 0.1 - 1 g of fish per liter per day
- Aeration: YES

- Adjustment of pH: NO
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 0.1 - 10 µmol x m^-2 x s-1

- Test concentrations:
- Results used to determine the conditions for the definitive study:
Based on a LC50 range of about 10 - 100 mg/L as derived for a similar compound (MAFS-093).
Nominal and measured concentrations:
0.2 mg/L (measured)
Reference substance (positive control):

Results and discussion

Lipid contentopen allclose all
Lipid content:
3.5 %
Time point:
start of exposure
Lipid content:
6.1 %
Time point:
end of exposure
Bioaccumulation factoropen allclose all
14 dimensionless
normalised lipid fraction
Remarks on result:
other: day 14
Remarks: environment / dose:0.2 mg/L
normalised lipid fraction
Remarks on result:
other: day 28
Remarks: environment / dose:0.2 mg/L
Details on kinetic parameters:
- Uptake rate constant (k1): not applicable, as no increase in test item concentration observed
- Depuration (loss) rate constant (k2): not applicable, as no increase in test item concentration observed
- Indication of bi- or multiphasic kinetics: not applicable, as no increase in test item concentration observed
- Computation / data analysis:not applicable, as no increase in test item concentration observed
Details on results:
- Mortality of test organisms: no
- Behavioural abnormalities: no anormaleous behavior
- Observations on body length and weight: no differences between control and test group
- Other biological observations: no
- Organ specific bioaccumulation: not examined
- Bound residues forming a plateau: no
- Mortality and/or behavioural abnormalities of control: no
- Loss of test substance during test period: no

Applicant's summary and conclusion

Validity criteria fulfilled:
Under the conditions of this assay, there was no significant bioaccumulation observed. The result is below the regulatory value of concern regarding bioaccumulation.
Executive summary:

Study Design

A minimised bioaccumulation study with rainbow trout (Oncorhynchus mykiss) was conducted to determine the bioconcentration potential of the test material.  An exposure (uptake phase) of 28 days was carried out. The depuration phase was waived, since the measured concentration in fish was < 50 µg test material / g fish. A flow-through test with 2 groups (one control group and one exposure group) was carried out. The concentration of the test item was determined via LC-MS/MS analysis. Four fish were sampled on uptake phase days 14 and 28 from the exposure group. Two fish were sampled from the control group on uptake phase day 28. Samples of the aqueous phase were taken and analysed on uptake phase days -2, -1, 0, 2, 7, 14, 16, 19, 20, 22, 23 and 28 from the exposure group and on uptake phase day 0 and 28 from the control group. The lipid content of the fish was determined at the start and end of the study from 2 fish for the exposure group and one of the control group.
The definitive study was conducted at DR.U.NOACK-LABORATORIEN, Sarstedt, Germany from June 13 to July 20, 2012 with the definitive exposure phase from June 13 to July 11, 2012, according to OECD Guideline 305 (Draft 2011).


No significant uptake of the test item in fish was observed. Therefore, no uptake I depuration rates and no bioconcentration factors (steady state and kinetic, respectively) have been calculated. The bioconcentration factors at any sampling date during the uptake phase have been calculated based on fish body weight.
Uptake phase:
The aqueous concentrations at the beginning (uptake days 0 and 2) were in the range of 65 to 75 % of the nominal values. Thereafter, they were stable in the range of 92 - 118 % of the nominal values throughout the uptake phase. There was no increase of the test item concentrations observed in the fish. All the measured concentrations in fish were below 50 µg test item / g fish.
No depuration rates were calculated since no significant uptake was observed. The depuration phase was waived.
The bioconcentration factors (any time and lipid normalised, calculated on day 28) determined in this study with the test item were 12 and 10, respectively.
The validity criteria regarding temperature, oxygen saturation and mortality were fulfilled. The mean measured aqueous concentration (days 0 to 28) was 0.2 mg/L. On the first two sampling days the measured concentrations were below 20 % of the mean measured concentration (65 to 75 % of the mean measured concentration). From uptake day 7 to uptake 28 the measured values were in the range of 92 to 118 % of the mean measured concentration. Only negligible amounts of the test item were found in any analysed fish. These values have no impact on the validity of the study.


Under the conditions of this assay, there was no significant bioaccumulation observed. The result is below the regulatory value of concern regarding bioaccumulation.