Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)

Deviations:

no

Remarks:

The study was conducted according to the test guidelines in effect at the time of study conduct.

Qualifier:

according to guideline

Guideline:

other: Bioconcentration of Chemical Substance in Fish Body specified in "Method for Testing New Chemical Substance, etc." (Environmental Protection Notification No. 5, Notification No. 615 of Pharmaceutical Affairs Bureau and MITI Basic Industry Bureau 1974

Deviations:

no

Remarks:

The study was conducted according to the test guidelines in effect at the time of study conduct.

GLP compliance:

yes

Radiolabelling:

no

Details on sampling:

For both the first and second concentration levels during exposure, the test water analysis was carried our once before and then throughout the first test fish analysis. One sample per analysis was used. For both the first and second concentration levels during exposure, the test fish analysis was carried out 5 times, the number of fish used per analysis was 4, and they were divided into 2 groups (2 per group). In the control group, analysis was carried out before and after the experiment, 4 per analysis were used, and they were divided into 2 groups (2 per group).

Details on preparation of test solutions, spiked fish food or sediment:

The sample provided and a 20 times amount of crystallized sugar were stone-milled; subsequently Megafac F-142D (dispersant) in a 20 times amount of the amount of the sample provided was added, and the mixture was stone-milled further. Ion-exchanged water was added to prepare a stock solution with a test substance concentration of 20 mg/L for the first concentration level and 2 mg/L for the second concentration level. Ro the control group, crystallized sugar and Megafac F-142D were dissolved in ion-exchanged water to prepare a stock solution having concentrations of 400 mg/L.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Strain: Cyprinus carpio
- Source: Sugishima Fish Farm
- Age at study initiation (mean and range, SD): <1 year
- Length at study initiation (length definition, mean, range and SD): 7.0-9.0 cm
- Health status: After rearing and storing, the fish were transferred to a conditioning tank for medicinal bathing. Subsequently they were conditioned in a state of flowing water at 25±2°C for 36 days. If any abnormality was observed during that period, the individual was removed. After reselection, transfer to a test tank, and medicinal bathing, the selected fish were conditioned at the same temperature as above in a state of flowing water for 42 days. After transferring to a conditioning tank, a mixture of 50 mg/L of fisher OTC and 7 g/L sodium chloride was used to carry out medicinal bathing for 24 hours. In the test tank, a mixture of 20 mg/L of Elverju and 7 g/L sodium chloride was used to carry out medicinal bathing for 24 hours.
- Description of housing/holding area: 100-L volume glass water tank
- Feeding during test
- Food type: Compounded feed for young carp (≥43.0% protein, ≥3.0% fat)
- Amount: Amount corresponding to about 2% of the body weight of test fish
- Frequency: two portions a day (once a day on holidays). No feed was provided for 24 hours prior to sampling of study fish.

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed): Upon delivery, those observed to be abnormal by the naked eye were removed and the remaining fish were exposed to a medicinal bath for prevention of diseases and extermination of parasites, and were reared for 18 days in a state of flowing water. For disease prevention, a mixture of 50 mg/L of fishery OTC (oxytetracycline hydrochloride) and 7 g/L sodium chloride was used as a medicinal bath for 24 hours. For parasite extermination, a bath of 30 µg/L of formalin for 24 hours was used twice.

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

28 d

Test temperature:

First concentration level: 25.0-25.2°C
Second concentration level: 25.0-25.2°C
Control group: 25.0-25.1°C

pH:

First concentrationlevel: 7.7-8.0
Secong concentration level: 7.7-8.0
Control group: 7.6-8.0

Dissolved oxygen:

First concentration level: 7.6-8.1 mg/L
Second concentration level: 7.7-8.0 mg/L
Control group: 8.1 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-L volume glass water tank
- Material, size, headspace, fill volume: Stock solution tank was a 25 L glass bottle that was replaced once/week
- Type of flow-through (e.g. peristaltic or proportional diluter): flowing water device assembled at the testing facility
- Renewal rate of test solution (frequency/flow rate): once/week
- No. of organisms: 38 for first and second concentration levels; 12 controls

Fish state of health, etc., was observed twice a day by the naked eye. The amount of test water, temperature, dissolved oxygen, and pH were measured and recored. During the experiment, the carp excreta, dirt on the water tank, etc. were cleaned once a day.

Nominal and measured concentrations:

5 and 50 µg/L

Details on estimation of bioconcentration:

The analyses of the test substance in the test water and fish were carried out by the liquid chromatography-mass spectroscopy (LC-MS) method. When the test substance was analysed by LC-MS, two peaks were detected. Therefore, quantitative determination was carried out for each peak. However, the concentration of each peak shown did not take into account the component composition as a test substance concentration shown in the standard solution preparation. For both the first and second concentration levels during exposure, the test water analysis was carried out once before and then throughout the first test fish analysis. One sample per analysis was used.
For both the first and second concentration levels during exposure, the test fish analysis was carried out 5 times, the number of fish used per analysis was 4, and they were divided into 2 groups (2 per group). Because the amount of sample reserved for fat content measurement from only 1 fish was insufficient, 2 per group were used.
In the control group, analysis was carried out before and after the experiment, 4 per analysis were used, and they were divided into 2 groups (2 per group). In addition, for fat measurement, 2 were selected making the total of 3 groups (2 per group).

Key result

Type:

BCF

Value:

<= 5.1 other: times

Time of plateau:

28 d

Remarks on result:

other: Main component

Remarks:

Conc.in environment / dose:50 µg/L

Key result

Type:

BCF

Value:

450 other: times

Time of plateau:

28 d

Remarks on result:

other: Subcomponent; 350-510 times

Remarks:

Conc.in environment / dose:50 µg/L

Type:

BCF

Value:

<= 5.1 other: times

Time of plateau:

28 d

Remarks on result:

other: Main component

Remarks:

Conc.in environment / dose:5 µg/L

Type:

BCF

Value:

270 other: times

Time of plateau:

28 d

Remarks on result:

other: Subcomponent; 270-340 times

Remarks:

Conc.in environment / dose:5 µg/L

Details on results:

The test substance concentrations in the test water were maintained above 88% of the value set. The fluctuations in test substance concentrations were maintained within ±20% of the mean measurement results.

Main Component: All of the final consecutive 3 analyses showed no detection, and consequently, no steady state bioconcentration factor could be calculated. However, the results on the bioconcentration factor were all less than 100 times, and thus, it was concluded that the steady state had been attained after 28 days.

Subcomponent: The results on the bioconcentration factor (mean) after 17, 24, and 28 days showed fluctuations within 20% of the mean bioconcentration factor of those 3 analyses, and consequently, it was concluded to have reached a steady state. Those results were used to calculate a steady state bioconcentration factor.

Component	Concentration Level	After 7 days	After 10 days	After 17 days	After 24 days	After 28 days
Main Component	1	≤5.1	≤5.1	≤5.1	≤5.1	≤5.1
		≤5.1	≤5.1	≤5.1	≤5.1	≤5.1
	2	≤5.1	≤5.1	≤5.1	≤5.1	≤5.1
		≤5.1	≤5.1	≤5.1	≤5.1	≤5.1
Subcomponent	1	360	350	410	410	470
		370	360	510	410	430
	Mean of 1	370	350	460	410	450
	2	380	370	430	350	270
		320	320	340	340	270
	Mean of 2	350	340	380	340	270

Validity criteria fulfilled:

yes

Conclusions:

First concentration level (main component): <5.1 times
Second concentration level (main component): <5.1 times
First concentration level (subcomponent): 350-510 times (mean of 450 after 28 days)
Second concentration level (subcomponent): 270-430 times (mean of 270 after 28 days)

Executive summary:

The bioconcentration of the test substance in carp (Cyprinus carpio) was examined. Test concentrations were 50 µg/L (first concentration level) and 5 µg/L (second concentration level). The analyses of the test substance in the test water and fish were carried out by the liquid chromatography-mass spectroscopy (LC-MS) method. For both the first and second concentration levels during exposure, the test water analysis was carried out once before and then throughout the first test fish analysis. One sample per analysis was used. For both the first and second concentration levels during exposure, the test fish analysis was carried out 5 times, the number of fish used per analysis was 4, and they were divided into 2 groups (2 per group). Because the amount of sample reserved for fat content measurement from only 1 fish was insufficient, 2 per group were used. In the control group, analysis was carried out before and after the experiment, 4 per analysis were used, and they were divided into 2 groups (2 per group). In addition, for fat measurement, 2 were selected making the total of 3 groups (2 per group).

All of the final consecutive 3 analyses of the main component showed no detection, and consequently, no steady state bioconcentration factor could be calculated. However, the results on the bioconcentration factor were all less than 100 times, and thus, it was concluded that the steady state had been attained after 28 days. The results on the Bioconcentration factor (mean) for the subcomponent after 17, 24, and 28 days showed fluctuations within 20% of the mean bioconcentration factor of those 3 analyses, and consequently, it was concluded to have reached a steady state. Those results were used to calculate a steady state bioconcentration factor. Bioconcentration for both concentration levels of the main component was <5.1 times. Bioconcentration for the subcomponent was 350-510 times at 50 µg/L (mean of 450 at 28 days) and 270-430 times (mean of 270 at 28 days) at 5 µg/L.

Description of key information

Bioconcentration for both concentration levels of the main component was <5.1 times. Bioconcentration for the subcomponent was 350-510 times at 50 µg/L (mean of 450 at 28 days) and 270-430 times (mean of 270 at 28 days) at 5 µg/L.