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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Sep 2019 to 09 Jan 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
2012
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Samples of the fresh test preparations were taken on Days 0, 5, 12 and 20 and of the expired test preparations on Days 1, 6, 13 and 21. Duplicate samples were taken and stored frozen
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item solutions were prepared by stirring an excess (10 mg/L) of test item in test water using a propeller stirrer at approximately 1500 rpm for 48 hours. After the stirring period any undissolved test item was removed by filtration (0.2 μm Gelman Acrocap filter, first approximate 500 mL used to pre-condition the filter was discarded) to produce the required 100% v/v saturated solution of the test item.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation (mean and range, SD): not specified
- Stage and instar at study initiation: adult
- Method of breeding: parthenogenesis
- Feeding during test
- Food type: Each daphnid received approximately 5 to 20 μL of an algal suspension (Raphidocelis subcapitata) daily and approximately 5 μL of GM 300 fish food suspension on Days 0 to 3. Feeding was at a level of approximately 0.1 to 0.2 mg carbon/daphnid/day, dependent on the age and size of the animals. Equal amounts of food were given to each daphnid.

ACCLIMATION
- Acclimation period: not specified
- Acclimation conditions (same as test or not): not specified
- Type and amount of food: Each culture was fed daily with a mixture of algal suspension (Raphidocelis subcapitata (formally known as Pseudokirchneriella subcapitata)) and GM300 fish food suspension.


Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
see in the "Any other information on results incl. tables" section
Test temperature:
see in the "Any other information on results incl. tables" section
pH:
see in the "Any other information on results incl. tables" section
Dissolved oxygen:
see in the "Any other information on results incl. tables" section
Salinity:
n.a.
Conductivity:
n.a.
Nominal and measured concentrations:
see in the "Any other information on results incl. tables" section
Details on test conditions:
TEST SYSTEM
- Test vessel: glass vessel
- Type (delete if not applicable): closed
- Aeration: no, the diluent water only was aerated prior to use.
- Renewal rate of test solution (frequency): Day 0 to 1, 5 to 6, 12 to 13 and 20 to 21
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): n.a.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted Elendt M4 medium
- Details in the "Any other information on results incl. tables" section

OTHER TEST CONDITIONS
- Photoperiod / Light intensity: 16 hours light (not exceeding 1500 Lux) and 8 hours darkness with 20 minute dawn and dusk transition periods for 21 days.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Immobilization
- Reproduction
- Body lenght
=> intervals: Days 0, 5, 12 and 20 and of the expired test preparations on Days 1, 6, 13 and 21

TEST CONCENTRATIONS
- saturated solution of the test item i.e. 0.052 µg/L
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
immobilisation
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
immobilisation
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.052 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
immobilisation
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Immobilisation of control: none
- Abnormal responses: none

 

Summary of Findings Following the Exposure of Daphnia magna for 21 Days

Geometric Mean Measured Concentration (μg/L)

Parental (P1) Generation Mortalities (Initial Population = 10 – Control Group)

(Initial Population = 9 – Test Group)

Total Number of Live Young

Number of Live Young from Parents Surviving to the End of the Test

 

Number of Live Young at the End of the Test Excluding Parents that were Accidental or Inadvertent Mortalities

Total

Accidental

Inadvertent

Total

Average per Parent

Total

Average per Parent

Control

1

0

1

1463

1463

163

1463

163

0.052

1

0

1

1393

1311

164

1311

164

 

Summary of Daily Observations

Day

Geometric Mean Measured Concentration (μg/L)

Control

0.052

Adults Surviving

Live Young

Adults Surviving

Live Young

1

10

0

9

0

2

10

0

9

0

3

10

0

9

0

4

9

0

9

0

5

9

0

9

0

6

9

0

9

0

7

9

0

9

0

8

9

141

9

86

9

9

0

9

39

10

9

0

9

0

11

9

272

9

209

12

9

0

9

2

13

9

0

9

0

14

9

317

9

290

15

9

0

9

0

16

9

0

9

0

17

9

382

9

290

18

9

0

9

84

19

9

0

8

0

20

9

123

8

160

21

9

228

8

151

TOTALS

9

1463

8

1311

           

 

 

Body Length of Surviving Adults at Day 21

Geometric Mean Measured Concentration (μg/L)

Individual Daphnia Lengths (mm)

1

2

3

4

5

6

7

8

9

10

Av

SD

Control

4.1

4.1

4.0

4.1

-

4.0

4.0

4.1

4.1

4.2

4.08

0.07

0.052

-

4.0

4.2

4.0

-

4.2

4.2

4.0

4.0

4.1

4.09

0.10

 

 

Reconstituted Water – Elendt M4 Medium

Main Compounds mg/L

Trace Elements* μg/L

Vitamins μg/L

CaCl2.2H2O

293.8

B

H3BO3

500

Thiamine HCl

75

MgSO4.7H2O

123.3

Fe

FeSO4.7H2O†

200

Cyanocobalamine (B12)

1.0

KCl

5.8

Mn

MnCl2.4H2O

100

Biotin (B6)

0.75

NaHCO3

64.8

Li

LiCl

50

 

 

Na2SiO3.9H2O

10.0

Rb

RbCl

50

 

 

NaNO3

0.274

Sr

SrCl2.6H2O

50

 

 

KH2PO4

0.143

Br

NaBr

12.4

 

 

K2HPO4

0.184

Mo

Na2MoO4.2H2O

25.2

 

 

 

Cu

CuCl2.2H2O

6.4

 

 

 

Zn

ZnCl2

6.3

 

 

 

Co

CoCl2.6H2O

2.5

 

 

 

I

KI

2.5

 

 

 

Se

Na2SeO3

1.0

 

 

 

V

NH4VO3

0.3

 

 

 

EDTA

Na2EDTA.2H2O

2500

 

 

Water Hardness: 2.5 mmol/L (= 250 mg/L as CaCO3) Alkalinity: 0.9 mmol/L

 

 

validation criteria

 

Required

Actual

Control mortality

=<20%

10%

Mean number of live young per surviving adult (control group)

>=60 after 21 days

163

Coefficient of variation for control group*

=< 25%

5.4%

Ephippia produced

0

0

Dissolved oxygen

>3 mg O2/L

≥8.5 mg O2/L

pH (control group)

6 to 9 Variation =< 1.5

7.6 to 8.7 1.1

Validity criteria fulfilled:
yes
Remarks:
For further details please refer to “Any other information on results incl. tables”.

Description of key information

EC10 (21 d) > 0.052 μg/L (geometric mean measured)

NOEC (21 d) >= 0.052 μg/L (geometric mean measured)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC10
Remarks:
No toxicity within the range of water-solubility
Effect concentration:
> 0.052 µg/L
Fresh water invertebrates
Dose descriptor:
NOEC
Remarks:
No toxicity within the range of water-solubility
Effect concentration:
>= 0.052 µg/L

Additional information

A study was performed to assess the chronic toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2012) No 211. Daphnia magna were exposed (10 replicates of a single daphnid per group) to solutions of test item at a nominal concentration of 100% v/v saturated solution (nominal concentration of 10 mg/L loading rate) for a period of 21 days under semi static conditions.

Due to the limited solubility of test item and low achievable test concentrations in the test media a "limit test" was conducted at a concentration of 100% v/v saturated solution to confirm that at the highest attainable test concentration no reduction of reproduction or adverse reactions to exposure were observed.

A nominal amount of test item (110 mg) was dispersed in 11 liters of test water with the aid of propeller stirring at approximately 1500 rpm for 48 hours. After 48 hours the stirring was stopped and any undissolved test item was removed by filtration through a 0.2 μm Gelman Acrocap filter (first approximate 500 mL discarded in order to pre-condition the filter) to give a 100% v/v saturated solution.

The concentration and stability of the test item in the test preparations were verified by chemical analysis on Days 0, 5, 12 and 20 (fresh media) and on Days 1, 6, 13 and 21 (expired media).

The numbers of live and dead adult Daphnia and young daphnids (live and dead) were determined daily. The Daphnia were fed daily with a mixture of algal suspension and GM 300 fish food suspension for Days 0 to 3 and from Day 4 onwards were fed an algal suspension only.

 Analysis of the fresh test preparations on Days 0, 5, 12 and 20 showed measured test concentrations to range from 0.025 to 0.094 μg/L. A general decline in measured test concentration of the old test preparations on Days 1, 6, 13 and 21 was observed to be between 0.035 to 0.062 μg/L and hence it was considered appropriate to calculate the results based on the geometric mean measured test concentration in order to give a “worst case” analysis of the data. The geometric mean measured concentration for the 100% v/v saturated solutions was determined to be 0.052 μg/L.

Exposure of Daphnia magna to the test item resulted in no effects with an EC10 (21 d) > 0.052 μg/L and a NOEC (21 d) >= 0.052 μg/L.