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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From November 02 to 07, 2016
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
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
2008
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
The test solutions were prepared by respective dilutions of a stock solution
Vehicle:
no
Details on test solutions:
The test solutions were prepared by respective dilutions of a 100 mg/l stock solution with aerated Daphnia medium.
Test organisms (species):
Daphnia magna
Details on test organisms:
Test organism: Daphnia magna (Straus, 1820),derived from a healthy stock and not first brood progeny
Age: less than 24 h
Breeding: Parental and young Daphnia held in 4 l glass aquaria (3 l medium) at 20±2 °C
Illumination: 16 h per day
Medium: Continuously aerated Elendt M4 medium; prepared with ultra-pure water (conductivity <1.5 µS/cm)
Feed: Suspension of Desmodesmus subspicatus in Elendt M4 medium with an optical density OD680 of about 15 units
Control of sensitivity: Acute reference test with potassium dichromate conducted twice a year
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
18–22 °C, controlled at ± 1 °C
pH:
6 to 9. The pH should normally not vary by more than 1.5 units in one test
Conductivity:
<1.5 µS/cm
Nominal and measured concentrations:
0.100, 0.050, 0.025, 0.0125 and 0.00625 mg/l nominal concentration
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 ml beakers, all-glass, with 50 ml of test medium, covered with a glass plateto avoid evaporation and contamination of the test solutions with dust
- Aeration: Continuously aerated
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 2
- No. of vessels per blank control (replicates): 3
- Test medium: Elendt M4 medium; prepared with ultra-pure water (conductivity <1.5 µS/cm)
- Feed: the Daphnia are not fed during the test

TEST MEDIUM
Test medium: Elendt M4 medium; prepared with ultra-pure water (conductivity <1.5 µS/cm)

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 h photoperiod a day, supplied by overhead white fluorescent tubes

EFFECT PARAMETERS MEASURED
Immobility: observations of immobile Daphnia were made after 24 and 48 h of exposure. Any abnormal behaviour or appearance was reported.
Temperature: determined in an additional flask without Daphnia at the beginning of the test and after 24 and 48 h of exposure.
Oxygen, pH: determined in the combined test solutions for each concentration at the beginning, and after 48 h of exposure.
Conductivity: determined in the combined test solutions for each concentration at the beginning of the exposure.

RANGE-FINDING STUDY
- Test concentrations: - first non-GLP range finding test: 1, 10 and 100 mg/l
- second non-GLP range finding test: 0.01, 0.1 and 1 mg/l
- Results used to determine the conditions for the definitive study: a first non-GLP range finding test with nominal concentrations of 1, 10 and 100 mg/l of INTERCURE® 18 was performed. At all three concentrations, 100% immobility was observed. Due to the high toxicity observed in the first non-GLP range finding test, a second non-GLP range finding test was performed with nominal concentrations of 0.01, 0.1 and 1.0 mg/l. At 0.01 mg/l 12.5 % immobilisation was observed; at 0.1 mg/l and 1.0 100 % of immmobilisation was observed.
Reference substance (positive control):
yes
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.087 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.058 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC10
Effect conc.:
ca. 0.034 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
ca. 0.029 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
ca. 0.01 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 0.01 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Determination of ECxand NOEC values after 24 h

After 24 h, the dose-response curve encompassed the range from no observed effects to 62.5% immobility. No significant effects (≤ 10 % immobilization) were observed in the blank controls.

Determination of ECxand NOEC values after 48 h

After 48 h, the dose-response curve encompassed the range from no observed effects to 100% immobility. No significant effects (≤ 10 % immobilization) were observed in the blank controls

Validity criteria fulfilled:
yes
Conclusions:
EC50 (48h) = 0.058 mg/l
Executive summary:

Method

The median effect concentration (EC50) and the no-effect concentration (NOEC) of INTERCURE 18 to Daphnia magna were investigated under static exposure conditions over a period of 48 h, following guideline OECD 202.

The investigated nominal concentrationswere 0.100, 0.050, 0.025, 0.0125 and 0.00625 mg/l.

40 individual Daphnia divided into 2 test vessels were exposed to each concentrationof the test item, and 60 Daphnia divided into 3 test vessels were used as blank controls.

Results

The 48 h EC50 value of INTERCURE 18 to Daphnia magna was 0.058 mg/l, based on the nominal concentrations.

Description of key information

EC50 (48 h) = 0.058 mg/l

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.058 mg/L

Additional information

The median effect concentration (EC50) and the no-effect concentration (NOEC) of INTERCURE 18 to Daphnia magna were investigated under static exposure conditions over a period of 48 h, following guideline OECD 202.

The investigated nominal concentrationswere 0.100, 0.050, 0.025, 0.0125 and 0.00625 mg/l.

40 individual Daphnia divided into 2 test vessels were exposed to each concentrationof the test item, and 60 Daphnia divided into 3 test vessels were used as blank controls.

Under the test conditions, the substance shows an EC50 (48h) = 0.058 mg/l