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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:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
no
Vehicle:
yes
Remarks:
acetone was used as solvent
Details on test solutions:
At the start of the test, 1000 mg of the test item were weighed in a 10 mL graduated flask and brought up to volume with acetone, to obtain the stock solution SsA at the concentration of 100 g test item/L;
0.250 mL of stock solution SsA were diluted in a 250 mL graduated flask and brought up to volume with ISO medium, to obtain the stock solution SsB at the concentration of 100 mg test item/L;
13.250 mL of stock solution SsB were diluted in a 250 mL graduated flask and brought up to volume with ISO medium, to obtain the test solution (C1) at the concentration of 5.3 mg test item/L.
One control series (CT SOLV) containing the solubilising agent acetone at the level used in the treatment was run in addition to the other groups (solvent content of 0.005%).
Test organisms (species):
Daphnia magna
Test type:
static
Water media type:
other: ISO medium (ISO 6341 test water described in ANNEX 3 of OECD N° 202),
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
The organisms are maintained in a thermostatic chamber at the temperature range of 20±2°C, with a photoperiod of 16 hours light and 8 hours dark.
pH:
The medium pH is in the range of 6-9.
Dissolved oxygen:
dissolved oxygen is ≥ 3 mg/L.
Nominal and measured concentrations:
Nominal test item conc. (mg/L) = 5.3
Details on test conditions:
The test solutions were not aerated and the daphnids were not fed during the test.
During the exposure period, the temperature in the thermostatic chamber was in the range of 20.00 -20.67°C and the temperature measured in the test medium was 21.1°C; the light intensity was in the range 1000 - 1400 Lux and a photoperiod of 16 hours light and 8 hours dark was applied.
Dissolved oxygen concentration and pH values were measured in the untreated and treated solutions, at the beginning and at the end of the test.
At the start of the test, the pH of the aerated water was 7.83 and the dissolved oxygen was 8.64 mg/L; the hardness of the test medium was 230 mg CaCO3/L.
During the test, the vessel position was modified on a daily basis and recorded in the study notebook.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 5.3 mg/L
Remarks on result:
other: equivalent to the limit of solubility
Details on results:
In this limit test, performed with 20 daphnids for each group, the presence of immobilised daphnids were evaluated after 24 and 48 hours of exposure. No other effects (e.g. behavioural effects, discoloration or trapping) were observed on the exposed organisms.
The test results are expressed as the percentage of immobilisation (% I) at 24 and 48 hours of exposure, as reported in table 5.
These data were calculated by the ratio between number of immobilised daphnids and total number of treated daphnids, according to the following formula:
% I = (number of immobilised organisms / number of exposed organisms) × 100
Reported statistics and error estimates:
The input data refers to the immobilization data evaluated after 24 and 48 hours of exposure and the statistical analysis was performed using software ToxRat Professional 3.2.1.
The assessment of the effects was based on the nominal concentration of test item.
A comparison of responses in control group and treatment group was performed by Fisher’s exact binomial test.
Validity criteria fulfilled:
yes
Conclusions:
The organisms were exposed to one concentration of test item TRIOLEATE DI TEA for 48 hours and the assessment of the effects was based on the nominal concentration.
The validity criteria of the biological test were satisfied.
No effects were observed on the exposed organisms and the 48h-EC50 was estimated to be greater than 5.3 mg/L of TRIOLEATE DI TEA (equivalent to the limit of solubility).
Executive summary:

The acute immobilisation test was performed to assess the effects of test item TRIOLEATE DI TEA on Daphnia magna after 48 hours of exposure under static conditions.

The test will be performed as limit test in order to demonstrate that there is no statistically significant effect at the tested concentration (chosen on the bases of the limit of solubility).

The organisms were exposed to 5.3 mg test item/L, plus 2 untreated groups (with and without solvent); for each group, 20 daphnids less than 24 hours old were used.

The assessment of the effects was based on the nominal concentrations of test item.

No effects were observed on the exposed organisms and the 48h-EC50 was estimated to be greater than 5.3 mg/L of TRIOLEATE DI TEA.

Description of key information

No effects were observed on the exposed organisms and the 48h-EC50 was estimated to be greater than 5.3 mg/L of TRIOLEATE DI TEA (equivalent to the limit of solubility).

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
5.3 mg/L

Additional information