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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:
experimental study
Adequacy of study:
key study
Study period:
From May 30, 2017 to June 01, 2017
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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
Because the test substance is poorly soluble in water, a saturated solution of the test substance was prepared according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23. The saturated (stock solution with nominal loading rate of 100 mg/L) was prepared by dispersing/dissolving the test substance into ISO medium two days before the start of the study. This solution was shaken for about 24 h at approximately 30°C and then equilibrated for about 24 h at approximately 20°C. The non-dissolved test material was removed by filtration through a fine (0.22 µm) filter to produce the 100% saturated solution. The test solutions were prepared by dilutions of this stock solution in a series corresponding to 1.0, 3.1, 9.8, 31.3 just before introduction of the Daphnia (start of the experiment).

Test organisms (species):
Daphnia magna
Details on test organisms:
Species and strain: Daphnia magna
Source: István Szent University, Hungary (Definitive test).
Breeding: the Daphnia are bred in Ecotoxicological Laboratory of CiToxLAB Hungary Ltd.
The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.
Justification of strain: Daphnia magna is the standard species of the acute immobilisation test.
Number of animals: There were 20 animals in test group and control group respectively, divided into 4 replicates (5 animals / replicate).
Age of the animals: they were less than 24 h old at the beginning of the test.
Acclimatization: there was no acclimatization because the water used was similar to the culture water.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
The reconstituted water (ISO medium) had a total hardness of 246 mg/L (as CaCO3).
Test temperature:
The water temperature was measured at the start of the experiment and at 24 h intervals thereafter in each test vessel. The test temperature was in the range of 20.4– 20.6°C in the test vessels. The additionally measured temperature in the climate chamber was between 20.2 and 20.9°C.
pH:
The pH of the test solution was not adjusted and not varied by more than 1.5 units in the test. The pH was measured at the start and at the end of the experiment in each test vessel and was in the range of 7.49 – 7.92.
Dissolved oxygen:
The dissolved oxygen concentration was measured in each test vessel at the start and at the end of the experiment and was in the range of 7.5 – 8.5 mg/L.
Nominal and measured concentrations:
Range-finding test:
Nominal: 0.1, 1, 10, 100 [% saturated solution]

Definitive test:
Nominal [% saturated solution]: 1.0, 3.1, 9.8, 31.3 and 100
Measured concentrations - geometric mean: 0.81; 2.49; 7.73; 24.10 and 77.24 mg/L
Details on test conditions:
Dilution water: Reconstituted water (ISO medium, according to OECD 202) was used as dilution water for both the range finding and definitive test. The same composition of reconstituted water was used for the tests and for breeding the test animals.

Light: the test was carried out in 16 h light/8 h dark cycle.

The test was performed under static conditions. The animals were not fed during the test.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (reference substance, tested twice a year)
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
25.8 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: Water accomodated fraction
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
2.49 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: Water accomodated fraction
Basis for effect:
mobility
Reported statistics and error estimates:
The 24 h EC50 of the test substance could not be calculated (due to the slight effect observed) and therefore determined directly from the raw data. The 48 h EC10 and EC50 values of the test substance were calculated using Probit analysis by TOXSTAT software.
For the determination of the LOEC and NOEC, the immobilization at the test concentrations was tested on significant differences to the control values by Dunnett’s Test using TOXSTAT software.
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the 48 h EC50 and NOEC of the test substance in Daphnia magna were determined to be 25.8 and 2.49 mg/L (measured geometric mean), respectively.

Executive summary:

A study was conducted to determine the toxicity of the test substance, PBBA to Daphnia magna according to OECD Guideline 202, EU Method C.2 and EPA Guideline OCSPP 850.1010, in compliance with GLP. The test was conducted over an exposure period of 48 h in a static system. A water accommodated fraction (WAF) at a nominal loading rate of 100 mg/L was prepared for preliminary range-finding and main test. As significant immobilization was observed in the range-finding test at the two highest examined concentration levels, a wide concentration range was applied in the definitive test. Subsequent dilutions were made from the WAF stock solution in a geometric series corresponding to 1.0, 3.1, 9.8, 31.3 and 100 %. The test concentrations were analytically determined at the start and end of the experiment. Twenty daphnids, divided into 4 groups of 5 animals each, were used for each test concentrations and for the control. The results were based on geometric mean measured concentrations.Under the study conditions, the 48 h EC50 and NOEC of the test substance in Daphnia magna were determined to be 25.8 and 2.49 mg/L (measured geometric mean), respectively (Sipos, 2017).

Description of key information

The 48 h EC50 and NOEC of the test substance in Daphnia magna were determined to be 25.8 and 2.49 mg/L (measured geometric mean), respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
25.8 mg/L

Additional information

A study was conducted to determine the toxicity of the test substance, PBBA to Daphnia magna according to OECD Guideline 202, EU Method C.2 and EPA Guideline OCSPP 850.1010, in compliance with GLP. The test was conducted over an exposure period of 48 h in a static system. A water accommodated fraction (WAF) at a nominal loading rate of 100 mg/L was prepared for preliminary range-finding and main test. As significant immobilization was observed in the range-finding test at the two highest examined concentration levels, a wide concentration range was applied in the definitive test. Subsequent dilutions were made from the WAF stock solution in a geometric series corresponding to 1.0, 3.1, 9.8, 31.3 and 100 %. The test concentrations were analytically determined at the start and end of the experiment. Twenty daphnids, divided into 4 groups of 5 animals each, were used for each test concentrations and for the control. The results were based on geometric mean measured concentrations.Under the study conditions, the 48 h EC50 and NOEC of the test substance in Daphnia magna were determined to be 25.8 and 2.49 mg/L (measured geometric mean), respectively (Sipos, 2017).