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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2016-04-13 to 2016-04-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: control; 100 mg/L (diluted by factor 50 prior to analysis)
- Sample storage conditions before analysis:All samples were stored at 6 ± 2 °C until preparation, if necessary. Prepared samples were stored at room temperature in the autosampler until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was melted prior to the start of the exposure at 30°C. The limit concentration (100.3 mg of the test item was weighed out) was freshly prepared with dilution water in a measuring with a volume of 1 L before the start of the exposure (0 hours). The limit concentration was mixed thoroughly by inverting the measuring flask 10 times per hand.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: STRAUS
- Age of parental stock: less than 24 hours
- Feeding during test: none

ACCLIMATION
- not necessary because the dilution water was equivalent to the culture medium
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
166 - 170 mg CaCo3/L
Test temperature:
20.3 - 20.5°C
pH:
7.33 - 8.50
Dissolved oxygen:
7.12 - 8.67 mg/L
Salinity:
NA
Conductivity:
491 - 502 µS/cm
Nominal and measured concentrations:
nominal concentration: 100 mg/L
measured concentration: 102 - 104 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers
- Type: loosely covered with watch glasses
- Material, size, headspace, fill volume: glass, 4 (ID) x 7 (H) cm, headspace, 50 mL capacity
- Renewal rate of test solution: The test solutions were renewed after 24 hours. A second set of test vessels were filled with the freshly prepared test solutions and the daphnids were transferred by pipette.
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4

TEST MEDIUM / WATER PARAMETERS
- Elendt M4 according to OECD 202 (modified to a total hardness of 160 and 180 mg CaCO3/L
- Intervals of water quality measurement: Prior to the start of the exposure (0 hours) and the water renewal (24 hours), the water quality parameters (i.e. pH-value, dissolved oxygen concentration, temperature, conductivity and total hardness) of the dilution water were measured. At the start of the exposure intervals (0 and 24 hours), the water quality parameters of the fresh media (i.e. pH-value, dissolved oxygen concentration) were measured in one additional replicate (without daphnids) of the limit concentration and the control. At the end of the exposure intervals (24 and 48 hours), the water quality parameters of the old media were measured in all replicates (containing daphnids) of the limit concentration and the control.

- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16/8 hours light/dark cycle
- Light intensity: diffuse light, light intensity of max 1340 lux

EFFECT PARAMETERS MEASURED: Immobilisation was determined in all groups after 24 and 48 hours.

RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobilisation was observed up to and including the highest dose tested. Based on this result, a limit concentration of 100 mg/L was chosen for the main test.
Reference substance (positive control):
yes
Remarks:
potassium dichomate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Any observations that might cause a difference between measured and nominal values: no
Results with reference substance (positive control):
- Results with reference substance valid? Yes
A reference test was conducted as an acute immobilisation test (acc. to AQS P 9/2 and OECD 202) in ISO test water (acc. to OECD 202 (2004), Annex 3) under static conditions with a test duration of 24 hours once per month in order to prove the validity of the test system and test conditions at the test facility.The EC50 - value for the most recent of the monthly performed reference tests was: EC50: 1.95 mg/L (Cl: 1.14 - 3.30 mg/L)

Table 1: Immobilisation Rates

Nominal concentration [mg/L]

Immobilisation (%)

24 hours

48 hours

Replicates

Replicates

1

2

3

4

mean

1

2

3

4

mean

100

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Table 2: Measured Concnetrations of the Test Item during the Definitive Test

 

0 hours (start of exposure interval)

24 hours (end of exposure interval)

24 hours (start of exposure interval)

48 hours (start of exposure interval)

Nominal concentration [mg/L]

Measured conc. [mg/L]

%

Measured conc. [mg/L]

%

Measured conc. [mg/L]

%

Measured conc. [mg/L]

%

100

102

102

101

101

104

104

101

101

control

< LOQ

< LOQ

< LOQ

< LOQ

LOQ: Limit of Quantification

Validity criteria fulfilled:
yes
Conclusions:
In the limit concentration 100 mg/L of the test item, no effects on Daphnia magna were observed. Thus, the EC50 value is greater than 100 mg/L.
Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the limit concentration 100 mg/L of the test item were determined according to OECD 202. The limit test was conducted with headspace under semi-static conditions over a period of 48 hours. The validity criteria of the guideline were fulfilled. In the limit concentration 100 mg/L, no effects on Daphnia magna were observed. Thus, the EC50 value of the test item is greater than 100 mg/L.

Description of key information

The acute immobilisation of the test item to daphnia magna was determined according to OECD guideline 202. The EC50 value after 48 h was determined to be greater than 100 mg/L.

Key value for chemical safety assessment

Additional information

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the limit concentration 100 mg/L of the test item were determined according to OECD 202. The limit test was conducted with headspace under semi-static conditions over a period of 48 hours. The validity criteria of the guideline were fulfilled. In the limit concentration 100 mg/L, no effects on Daphnia magna were observed. Thus, the EC50 value of the test item is greater than 100 mg/L.