Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 NOV 2015 - 4 MAR 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

4 April 1984

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

- Method of mixing into soil: Aliquots of the test substance were dissolved in 40 mL acetone to give a solvent stock solution. These were added to a certain amount of silica sand and the solvent was allowed to evaporate off prior to incorporation into formulated artificial soil with deionised reverse osmosis water. This was mixed with the deionized water by a mixer to give the test item concentrations of 62.5, 125, 250, 500 and 1000 mg/kg, repectively and a nominal moisture content of 40-60% by mass of the total water-holding capacity. The test medium preparation process of the blank control group was same as ofthe other groups, but without the solvent and the test substance. The test medium preparation process of the solvent control group was same as of the other groups, but without the test substance.
- Controls: blank control, solvent control, positive control (Chloroacetamide)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Concentration of vehicle in test medium (stock solution and final test solution): Aliquots of the test substance were dissolved in 40 mL acetone to give a solvent stock solution (and the solvent allowed to evaporate off prior to incorporation into formulated artificial soil)
- Evaporation of vehicle before use: yes

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworms (Eisenia fetida)
- Source: The earthworms were purchased from Jiang Su province Jurong Stock Farm (ID: EF-MKT-150915).
- Age at test initiation: adult
- Weight at test initiation: 300 to 600 mg

ACCLIMATION
- Acclimation period: All newly acquired earthworms were quarantined and observed for 14 days prior to use in the test.
- Acclimation conditions: Earthworms are bred on a substrate consisting of 50% by volume peat and 50% by volume cow manure and kept under 20 ± 2°C for 7 days prior to testing. The test organisms were with clitellum and were transferred into artificial soil (without test substance) approximately 24 hours prior to the start of the test.

Study type:

laboratory study

Substrate type:

artificial soil

Remarks:

10 % w/w Sphagnum peat, 20 % w/w Kaolinite clay, 70 % w/w Silica sand (screened with 0.2 mm sieve)

Limit test:

no

Total exposure duration:

14 d

Post exposure observation period:

none

Test temperature:

20.1 to 20.5°C

pH:

6.16 - 6.25

Moisture:

27.91 to 29.64% dry weight at initiation and 27.07 to 28.23% dry weight at termination

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1 liter closed glass vessel
- Amount of soil or substrate: approximately 750 g wet weight of substrate
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4 replicates
- No. of replicates per control: 4 replicates
- No. of replicates per vehicle control: 4 replicates

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition: 10 % w/w Sphagnum peat, 20 % w/w Kaolinite clay, 70 % w/w Silica sand (screened with 0.2 mm sieve)
- Pretreatment of soil: The pH of the artificial soil was adjusted to 6.0 ± 0.5 by the addition of calcium carbonate. These ingredients were weighed and mixed in the above proportions. Moisture content of the test substrate was adjusted to 40 - 60% by mass of the total water-holding capacity with the deionized water. The highest measured value was 66% before the test initiation (appropriate moisture content is 26 - 40%). The water content did not vary by more than 10% from that at the start of the test.

OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- Light intensity: 555 - 680 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : LC50

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: Concentrations for the main test were based on the results of the range-finding test (10, 100, 1000 mg/kg test substance, solvent control and blank control without replicates).
- Test concentrations: 62.5, 125, 250, 500 and 1000 mg/kg

Nominal and measured concentrations:

Nominal: 62.5, 125, 250, 500 and 1000 mg/kg

Reference substance (positive control):

yes

Remarks:

Chloroacetamide

Duration:

7 d

Dose descriptor:

LC50

Effect conc.:

295.4 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% confidence interval: 259.2 - 336.7 mg/kg dry soil weight

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

207.3 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% confidence interval: 185.2 - 231.4mg/kg dry soil weight

Details on results:

- Mortality at end of exposure period: 62.5 mg/kg: 0%, 125 mg/kg: 5%, 250 mg/kg: 73%, 500 mg/kg: 100%, 1000 mg/kg: 100%
- Changes in body weight of live adults (% of initial weight) at end of exposure period: Weight reduction after 14 d: blank control: 14.73% ± 5.08, solvent control: 19.16% ± 5.64, 62.5 mg/kg: 20.79% ± 4.24, 125 mg/kg: 26.76% ± 5.40, 250 mg/kg: 64.32% ± 5.90

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Relevant effect levels: The 14-days LC50 for chloroacetamide was 16.2 mg/kg dry soil weight.

Reported statistics and error estimates:

Data were analyzed by Maximum Likelihood-Probit to calculate the LC50 with 95% confidence limits using software Toxcalc v5.0.32. The differences of the average body weight of the surviving earthworms between the blank control group and the treatment groups were determined by using the Homoscedastic t Test and Dunnett's Test at the end of the study. The data analyses were carried out with Toxcalc software v5.0.32.
Compared with blank control group, the average weight of the living earthworms at 250 mg/kg treatment group had significant differences (According to the result of Dunnett's Test, p=5.9E-10, p<0.05) of the variance t test at the end of the test; for the solvent control, there were no significant differences (According to the result of Homoscedastic t test, p=0.34, p>0.05) of the variance t test at the end of the test.

Validity criteria fulfilled:

yes

Conclusions:

The LC50 (7 d) value was determined to be 295.4 mg/kg dry soil weight and the 95% confidence interval was 259.2 to 336.7 mg/kg dry soil weight. The LC50 (14 d) value was determined to be 207.3 mg/kg dry soil weight and the 95% confidence interval was 185.2 to 231.4 mg/kg dry soil weight.

Executive summary:

The acute toxicity of the test substance to Eisenia fetida was determined in a 14 days artificial soil test according to "Ministry of environmental protection of the people's Republic of China, The Guidelines for the Testing of Chemicals-Effects on Biotic Systems, 2013, 207 Earthworm, Acute Toxicity Test" and "OECD, Guidelines for the Testing of Chemicals, 1984, 207 Earthworm, Acute Toxicity Test", in compliance with GLP.

Based on the results of a range-finding test, 5 treatment groups, one control group and one solvent control group, each consisting of four replicates of 10 worms per concentration were included in the main test. The nominal concentrations of the treatment groups were 62.5, 125, 250, 500 and 1000 mg/kg dry artificial soil weight. The number of mortalities were determined after 7 and 14 days exposure. The mortalities of the earthworms in the blank control group and solvent control group were 0%, which was not more than 10 percent, i.e. the test is evaluated as valid.

Under the tested conditions, the LC50 (7 d) in earthworms (Eisenia fetida) was 295.4 mg/kg dry soil weight and the 95% confidence interval was 259.2 to 336.7 mg/kg dry soil weight, the LC50 (14 d) was 207.3 mg/kg dry soil weight and the 95% confidence interval was 185.2 to 231.4 mg/kg dry soil weight.

Description of key information

Key, acute toxicity to earthworms (Eisenia fetida), OECD 207, GLP, LC50 (14d) 207.3 mg/kg soil dw

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

207.3 mg/kg soil dw

Additional information

Acute toxicity to earthworms (E. fetida), OECD 207

The acute toxicity of the test substance to Eisenia fetida was determined in a 14 days artificial soil test according to "Ministry of environmental protection of the people's Republic of China, The Guidelines for the Testing of Chemicals-Effects on Biotic Systems, 2013, 207 Earthworm, Acute Toxicity Test" and "OECD, Guidelines for the Testing of Chemicals, 1984, 207 Earthworm, Acute Toxicity Test", in compliance with GLP.

Based on the results of a range-finding test, 5 treatment groups, one control group and one solvent control group, each consisting of four replicates of 10 worms per concentration were included in the main test. The nominal concentrations of the treatment groups were 62.5, 125, 250, 500 and 1000 mg/kg dry artificial soil weight. The number of mortalities were determined after 7 and 14 days exposure. The mortalities of the earthworms in the blank control group and solvent control group were 0%, which was not more than 10 percent, i.e. the test is evaluated as valid.

Under the tested conditions, the LC50 (7 d) in earthworms (Eisenia fetida) was 295.4 mg/kg dry soil weight and the 95% confidence interval was 259.2 to 336.7 mg/kg dry soil weight, the LC50 (14 d) was 207.3 mg/kg dry soil weight and the 95% confidence interval was 185.2 to 231.4 mg/kg dry soil weight.