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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:
13.02.-17.02.2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
Preparation of Sample Solutions: The samples of test solutions were prepared and delivered by Ecotoxicity group. The samples were analyzed on the day of delivery. The samples were analysed non-diluted.
Details on test solutions:
The stock solution of the test substance was prepared in the dilution water. 100 mg of the test substance was weighed into 1000 mL of the dilution water for the preliminary test. The stock solution was ultrasonicated for 20 minutes. The concentrations of solutions used in the preliminary test were obtained by dilution of the stock solution with dilution water.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM- Common name: Daphnia magna- Strain: Straus- Source: own laboratory breeding.- Age at study initiation: young Daphnia born in 24h- Method of breeding: aperiodic parthenogenesis - Feeding during test: noACCLIMATION- Acclimation period: 48h- Acclimation conditions: same as test- Type and amount of food: a mixture of algae- Health during acclimation: mortality control, healthy
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
Ca+Mg ions2.52-2.53 mmol/L preliminary study
Test temperature:
20±2°C
pH:
7.8
Dissolved oxygen:
>3 mg/L
Conductivity:
1.16 µS·cm-1
Nominal and measured concentrations:
100, 50, 10, 5, 1 mg/L preliminary test
Details on test conditions:
TEST SYSTEM- Test vessel: glass beakers, 50 ml- Type: open- Aeration: withoutNumber of test animals: 20 for each concentration and control Number of replicates (per concentration): 2Number of test animals per replicate: 10Volume of test substance solution: 50 mL (least 2 ml per individual)Dilution water was prepared just before the test by admixing 2.5 mL of stored solutions A, B, C and D into 1000 mL of deionized water.A.117.6 g CaCl2.2H20 in 1 L of deionized waterB.49.3 g MgSO4.7H2O in 1 L of deionized waterC.25.9 g NaHCO3 in 1 L of deionized waterD.2.3g KCl in 1 L of deionized water
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
Reference testThe sensitivity of the test species and correctness of test performance is periodically verified in six-month period by testing with the reference substance, potassium dichromate.The results of the verification test with K2Cr2O7, carried out in period from 15.04. to 17.04.2015 are the following:24 hour – EC50 = 1.95 mg.L-1(95% confidence limit: 1.75 – 2.15 mg.L-1)48 hour – EC50 = 0.86 mg.L-1(95% confidence limit: 0.70 – 1.02 mg.L-1)
Validity criteria fulfilled:
yes
Conclusions:
The experiment with the concentration of 100 mg·L-1 included in the preliminary test has been performed using 20 daphnia, therethrough the conditions of the limit test givenin guidelines have been fulfilled. It was demonstrated that the EC50 is higher than this concentration.No immobilisation was observed in the preliminary test. Therefore exact values of EC50 could not be calculated and the values of EC are given in the form of a range. The EC0 and EC100 values are identified by direct observation.There is stated in the guideline that, if evidence is available to demonstrate that the concentration of the test substance has been satisfactorily maintained within ± 20 percent of the nominal or measured initial concentration throughout the test, the results can be based on nominal or measured initial values.Because concentrations of the test substance have been satisfactorily maintained within ± 20 percent of the measured initial concentration throughout the test, the nominal concentrations were used for all evaluations and results.Test results 24 hour – EC50 >100 mg·L-1(nominal concentration)48 hour – EC50 > 100 mg·L-1(nominal concentration)24 hour – EC0 = 100 mg·L-1(nominal concentration)48 hour – EC0 = 100 mg·L-1(nominal concentration) 24 hour – EC100 > 100 mg·L-1(nominal concentration)48 hour – EC100 > 100 mg·L-1(nominal concentration)
Executive summary:

The test substance, Acid Yellow 25, was tested in acute immobilisation test on Daphnia magna.

The test was performed according to method C.2 – Daphnia sp. Acute Immobilisation Test, Council Regulation (EC) No. 440/2008, published in O.J.L 142, 2008.

 

The preliminary test was performed in a range of the test substance nominal concentrations 1 – 100 mg·L-1. The test was performed as static. Based on no toxicity of the test substance found in preliminary test, the study was terminated. The experiment with the concentration of 100 mg·L-1included in the preliminary test has been performed using 20 daphnia, therethrough the conditions of the limit testgiven in guidelinehave been fulfilled. It was demonstrated that the EC50is higher than this concentration.

 

The samples for analytical determination were taken at the beginning and at the end of the test. The analytical results from the preliminary test showed, that the test substance AcidYellow 25was stable in the dilution water at conditions of the test.

 

There is stated in the guideline that, if evidence is available to demonstrate that the concentration of the test substance has been satisfactorily maintained within ± 20 percent of the nominal or measured initial concentration throughout the test, the results can be based
on nominal or measured initial values.

The nominal concentrations were used for all evaluation and results.

Test results:

24 hour – EC50>100 mg·L-1(nominalconcentration)

48 hour – EC50>100 mg·L-1(nominalconcentration)

 

24 hour – EC0= 100mg·L-1                 (nominalconcentration)

48 hour – EC0= 100mg·L-1                 (nominalconcentration)

 

24 hour – EC100>100 mg·L-1              (nominalconcentration)

48 hour – EC100>100 mg·L-1              (nominalconcentration)

Description of key information

The test was performed according to method C.2 – Daphnia sp. Acute Immobilisation Test, Council Regulation (EC) No. 440/2008, published in O.J.L 142, 2008.

Only one study is available.

GLP study.

Klimish score 1.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information