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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
See Read Across Justification
Adequacy of study:
key study
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See the Read Across justification document
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Name: Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine
CAS No.: 68425-57-0
Physical state: white solid at 20 °C (turbid, non-pourable paste)
Batch No.: PU61810016
Re-certification date of batch: 16 June 2018
Purity: 100 % (UVCB)
Moisture, % (KF) 1,2
pH, 10% in dW 7,2
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Analytical monitoring:
yes
Details on sampling:
Analytical data are required by the guidelines for verification of test item concentrations as well as the stability of the test item over the entire test period. Analytical samples were taken from all test item concentrations and control at test start and after 24 hours from fresh and aged solutions and after 48 hours from aged solutions. For each sampling also a retain sample was taken.500 µL samples were taken and stabilized with 500 µL methanol.All samples were stored deep frozen until they were transferred to the analytical laboratory.
Vehicle:
no
Details on test solutions:
Reconstituted test water consisting of analytical grade salts dissolved in purified water (ISO test water) was used.
Test organisms (species):
Daphnia cucullata
Details on test organisms:
Daphnia magna Straus, Clone V, was used as the test organism. The animals are continuously bred in the laboratory and were originally purchased in a healthy condition from the Federal Environment Agency in Berlin/Germany.Daphnia magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. The pH-value of the aerated water was within a range of 6.0 – 9.0. The dissolved oxygen was above 60 % saturation and the total hardness 140 - 250 mg/L (as CaCO3), corresponding to 7.8 - 14°dH. The animals were fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week. The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 hours of illumination and 8 hours of darkness. The medium was changed three times per week. A pipette was used to separate the young daphnids from the adults. Freshly hatched daphnids less than 24 hours old were used for the test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
At test initiation the total hardness was 14°dH (250 mg/L as CaCO3).
Test temperature:
19.3 – 20.8 °C
pH:
At test initiation the pH-value of the control (untreated test medium) was 7.45.
Dissolved oxygen:
At test initiation the oxygen concentration was 8.6 mg/L.
Salinity:
Reconstituted test water consisting of analytical grade salts dissolved in purified water (ISO test water) was used. The ratio of Ca:Mg and Na:K was 4:1 and 10:1, respectively, based on molarity. The conductivity was 745 µS/cm.
Conductivity:
Reconstituted test water consisting of analytical grade salts dissolved in purified water (ISO test water) was used. The ratio of Ca:Mg and Na:K was 4:1 and 10:1, respectively, based on molarity. The conductivity was 745 µS/cm.
Nominal and measured concentrations:
The measured content of A.I./test item was between 96 % and 106 % of nominal in the fresh samples with a mean initial concentration of 99 % of nominal. In the aged samples the measured content was between 87 % and 101 % of nominal with a mean measured concentration of 94 % of nominal. Therefore toxicological endpoints were evaluated using the nominal and the actual concentrations (based on the geometric mean of each measured concentration) of the test item.
Details on test conditions:
Test procedure: semi-static
Duration: 48 hours
Temperature: 19.3 – 20.8 °C
Oxygen concentration: ≥ 8.5 mg/L
pH-value: 7.45 – 8.06
Exposure to light: 16 hours photoperiod /8 hours darkness daily
Feeding: none
Test vessels: four 100 mL glass beakers per concentration, each filled with ~ 50 mL, one additional replicate for pysico - chemical measurements without test organisms
Loading: ~ 10 mL of test solution for each animal
Aeration: none
Number of animals: 20 per concentration in 4 replicates of 5
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1.94 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
4.02 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
1.87 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
In order to check the validity of the results, the toxicity of the reference item potassium dichromate was tested at 1.00 and 2.00 mg/L with 20 test organisms per test concentration. The results indicate an EC50 (24 h) of the reference item potassium dichromate between 1.00 mg/L and 2.00 mg/L. Since the results are in accordance with the requirements of the OECD guideline 202 and fall within the historical data generated with the reference item at the testing facility, the daphnids were suitable for the determination of the toxicological effects of the test item.
Reported statistics and error estimates:
The values for EC50 were determined by Weibull analysis using linear max. likelihood regression. The evaluation of data was performed by ToxRat Professional 3.2.1.

Results

Biological Assessment

After 24 h and 48 h the immobilised daphnids were counted. All daphnids not able to swim within 15 seconds after gentle agitation of the test vessel were considered to be immobilised. If present, behavioural changes of daphnids were recorded at 24 and 48 hours after starting the test.

Validity Criteria of the Study

Control immobilisation: The percentage of immobilisation should be ≤ 10 %. In this study the control immobilisation was 0 %.

Oxygen concentration: The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was ≥ 8.5 mg/L.

Biological Results

After 24 hours of exposure no immobilisation was observed in the control and up to and including 1.87 mg/L. 55 % immobilisation was observed at 3.27 mg/L and 75 % of immobilisation at 5.71 mg/L. In the highest test item concentration of 10.0 mg/L all daphnids were immobile. Daphnids in the test item concentrations of 3.27 mg/L and above were sticky. After 48 hours of exposure no immobilisation was observed in the control. 30 % immobilisation was observed at 1.07 mg/L and 35 % immobilisation was observed at 1.87 mg/L. 85 % of the daphnids were immobile in the test item concentration of 3.27 mg/L. In the two highest test item concentrations of 5.71 mg/L and 10.0 mg/L all daphnids were immobile. After 48 hours the same observations were made as after 24 hours.

Analytical Results

The measured content of A.I./test item was between 96 % and 106 % of nominal in the fresh samples with a mean initial concentration of 99 % of nominal. In the aged samples the measured content was between 87 % and 101 % of nominal with a mean measured concentration of 94 % of nominal. Therefore toxicological endpoints were evaluated using the nominal and the actual concentrations (based on the geometric mean of each measured concentration) of the test item.

Statistical Results

All toxicological endpoints were evaluated using nominal concentrations.

Table: Results of the test, 48 h values

   Control  1.07  1.87  3.27  5.71  10.0
     mg/l
  immobilised daphnids after 48 h
Group 1  0  2  2  4  5  5
 Group 2  0  3  2  3  5  5
Group 3  0  1  1  5  5  5
 Group 4  0  0  2  5  5  5
Σ  0  6  7  17  5  5
 %  0  30  35  85  100  100

Table: Determined concentrations of the test item

 Test item  Sampling  Test item   
 nominal [mg/l]  [h]  [mg/l]  % of nominal
 Control

0

24 fresh

48 aged

n.d.

n.d.

n.d.

-

-

-

 1.07

0

24 fresh

48 aged

1.13

1.08

1.08

106

101

101

 1.87

0

24 fresh

48 aged

1.80

1.86

1.87

96

99

100

 3.27

0

24 fresh

48 aged

3.25

3.07

3.10

99

94

95

 5.71

0

24 fresh

48 aged

5.77

5.51

4.94

101

96

87

 10.0

0

24 fresh

48 aged

10.1

9.91

8.72 

101

99

87

Validity criteria fulfilled:
yes
Conclusions:
According to the results of the OECD GLP 202 study, the EC50 (48 h) ogf the test item was determined to be 1.94 mg/L (nominal). The corresponding NOEC (48 h) could not be observed.
Executive summary:

The objectives of this study were to determine the immobilisation effect of the test item on the water flea Daphnia magna under worst-case exposure conditions, the no observed effect concentration (NOEC) and the effect median concentration (EC50), where possible. The principles were the exposure of daphnids to test solutions and observation of immobilisation after 24 and 48 hours of exposure under semi-static conditions. The study was performed according to OECD test guideline 202 (2004). According to the results of the OECD GLP 202  study, the EC50 (48 h) ogf the test item was determined to be 1.94 mg/L (nominal). The corresponding NOEC (48 h) could not be observed.

Description of key information

The toxicity to invertebrates was evaluated with results of a similar substance, tested according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia). See the Read Across justification.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
1.94 mg/L

Additional information