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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 01 March, 1994 to 19 May, 1994
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:
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:
Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature
Analytical monitoring:
yes
Details on sampling:
For the analytical measurements of the test substance concentrations duplicate samples from the freshly prepared test media of the nominal test concentration 100 mg test substance/L and the solvent control were taken just before the start of the test.
For the determination of the stability of the test substance under test conditions, duplicate samples from the test medium of nominal 100 mg test substance/L and the solvent control were collected at the end of the test (after 48 h) out of the test by pouring the contents of the test beakers into the sampling flasks. The concentrations of the test substance were analysed in the duplicate test media samples from the nominal test concentration of 100 mg/L and both sampling dates (0 and 48 h). From the solvent control samples only one of the duplicate samples were analysed from both sampling dates. All samples are kept stored at -20 °C to enable additional analyses.
Vehicle:
yes
Details on test solutions:
According to the results of the pre-experiments to the solubility and the dosage of the test substance, a stock "solution" was prepared by suspending the test substance in the emulsifier Tween 80: 100 mg test substance were homogeneously mixed into 100 mg Tween 80, and then this mixture was filled up with test water to 1000 mL. Thus, this solution contained 100 mg/L test substance and 100 mg/L Tween 80. The test medium was intensively mixed. The only nominal concentration tested was 100 mg test substance/L with the auxiliary emulsifier concentration of 100 mg Tween 80/L. Additionally, a control (test water without any additions) and a solvent control (100 mg Tween 80/L test water) were tested.
Test organisms (species):
other: Daphnia magna Straus
Details on test organisms:
The study was performed with young Daphnia (at the start of the test 6-24 h old) of a clone of the species Daphnia magna Straus. The clone is bred in the laboratories of RCC under standardized conditions. The cultivation of the parental Daphnia was performed in reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
250 mg/L as CaCO3
Test temperature:
20 ⁰C
pH:
7.9 to 8.0
Dissolved oxygen:
8.5 mg/L or higher
Nominal and measured concentrations:
Nominal: 100 mg/L
Mean measured: 80.3 mg/L
Details on test conditions:
In the only test concentration (nominal 100 mg/L), in the control and in the solvent control 20 Daphnia were tested, divided into four groups of five animals, each group in 250 mL test medium in a glass-beaker (400 mL). The Daphnia were not fed during the test period. The test was performed in an air-conditioned room.

Water temperature: 20 ⁰C during the test period
Light: 16 h per day, approx. 200 - 600 Lux
Test water: reconstituted water: in deionized water with a conductivity lower than 0.1 µS/cm (Milli-Q-water) analytical grade salts were dissolved to following nominal concentrations, and the water was aerated to oxygen saturation:
CaCl2 x 2H2O: 2 mmol/L (= 294 mg/L)
MgSO4 x 7H2O: 0.5 mmol/L (= 123 mg/L)
NaHCO3: 0.75 mmol/L (= 65 mg/L)
KCl: 0.075 mmol/l (= 5.8 mg/L)
Water Hardness: 2.5 mmol/L (= 250 mg/L) as CaCO3
Alkalinity: 0.8 mmol/L
Ratio of Ca:Mg = 4:1; Na:K = 10 : 1
The Daphnia have not been fed, and the test media have not been aerated during the test period.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 80.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Remarks on result:
other: (the 48h EC50 of the test substance could not be determined due to the low water solubility and low toxicity of the test substance)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 80.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: (since concentrations in excess of nominal 100 mg test substance have not been tested, the NOEC might even be higher than this concentration)
Details on results:
In the control, the solvent control and in the only test concentration of nominal 100 mg test substance/L, no immobilized or dead test animals were observed during the test period of 48 h. Therefore, the 48 h NOEC (highest tested concentration without toxic effects after the exposure period of 48 h), respectively, the 48 h EC0 of the test substance to Daphnia magna was determined to be at least nominal 100 mg test substance/L (mean measured concentration: 80.3 mg/L). Since concentrations in excess of nominal 100 mg test substance/L have not been tested, the NOEC might even be higher than this concentration. The 48h EC50 of the test substance could not be determined due to the low water solubility and low toxicity of the test substance. During the test period the dissolved oxygen concentrations in the test media were always 8.5 mg/L or higher, the pH-values in the range from pH 7.9 to 8.0.

Analytical results:


The analytically determined test substance concentrations in the samples from the freshly prepared test medium at the start of the test amounted to 82.7 % of the nominal value and 77.8 % were found in the samples, taken at the end of the test. These low measured values were obviously caused by the low water solubility of the test substance. In the biological test it was observed that after 24 and 48 h test period at least a part of the test substance had precipitated and was lying at the bottom of the test beakers. The mean value of the measured concentrations in the samples from the start and the end of the test amounted to 80.3 % of the nominal concentration of 100 mg/L. The reported biological results are related to the nominal test concentration as well to the mean measured test substance concentration of 80.3 mg/L.

Validity criteria fulfilled:
yes
Conclusions:
The 48 h NOEC and EC0 of the test substance were determined to be at least 100 mg/L (nominal, i.e. mean measured concentration of 80.3 mg/L). Since concentrations in excess of nominal 100 mg test substance/L have not been tested, the NOEC might even be higher than this concentration. The 48 h EC50 could not be determined due to the low water solubility and low toxicity of the test substance.
Executive summary:

The acute toxicity of the test substance (of ca. 93 % purity) to Daphnia magna was determined in a 48 h static test according to EU Method C.2 and OECD Guideline 202 in compliance with GLP.


 


A limit test was performed with only one test concentration of nominal 100 mg test substance/L to demonstrate that the test substance had no toxic effect up to this concentration.


 


The analytically determined test substance concentrations in the freshly prepared test medium at the start of the test amounted to 82.7 % of nominal value, and 77.8 % were found in the samples taken at the end of the test. These low measured values were caused by the low water solubility of the test substance. In the control, the solvent control and in the only test concentration of nominal 100 mg test substance/L, no immobilized or dead daphnids were observed over 48 h. The 48 h NOEC and EC0 of the test substance were therefore determined to be at least 100 mg/L (nominal, i.e. mean measured concentration of 80.3 mg/L).


 


After 24 and 48 h, at least a part of the test substance had precipitated and was lying at the bottom of the test beakers. Since concentrations in excess of 100 mg/L were not been tested, the NOEC might even be higher than this concentration. The 48h EC50 could not be determined due to the low water solubility and low toxicity of the test substance.

Description of key information

The 48-hour EC50 was found to be greater than 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

The acute toxicity of the test substance (of ca. 93 % purity) to Daphnia magna was determined in a 48 h static test according to EU Method C.2 and OECD Guideline 202 in compliance with GLP.


A limit test was performed with only one test concentration of nominal 100 mg test substance/L to demonstrate that the test substance had no toxic effect up to this concentration. The analytically determined test substance concentrations in the freshly prepared test medium at the start of the test amounted to 82.7 % of nominal value, and 77.8 % were found in the samples taken at the end of the test. These low measured values were caused by the low water solubility of the test substance. In the control, the solvent control and in the only test concentration of nominal 100 mg test substance/L, no immobilized or deadDaphniawere observed over 48 h.The 48 h NOEC and EC0 of the test substance were therefore determined to be at least 100 mg/L (nominal, i.e. mean measured concentration of 80.3 mg/L).


 


After 24 and 48 h, at least a part of the test substance had precipitated and was lying at the bottom of the test beakers. Since concentrations in excess of 100 mg/L were not been tested, the NOEC might even be higher than this concentration. The 48 h EC50 could not be determined due to the low water solubility and low toxicity of the test substance.