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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:
yes
Remarks:
Minor: During both the range-finding and definitive tests the temperature range exceed the maximum deviation of ± 1 °C
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Identification: Hydroxypropyl, 2-, trimethylammonium formate
Physical state/Appearance: Clear colorless liquid*
Batch Number: Chernil.20160628.B
CAS#: 62314-25-4
Purity: 95.25% active in water
Expiry Date: 28 June 2017
Storage Conditions: Room temperature in the dark over silica gel
Analytical monitoring:
yes
Details on sampling:
A sample of each test concentration was taken for chemical analysis at 0 and 48 hours in order to determine the stability of the test item under test conditions.
Samples were taken from the control and the 100 mg/L test group from the bulk test preparation at 0 hours and from the pooled replicates at 48 hours for quantitative analysis.
All samples were stored frozen prior to analysis.
Vehicle:
no
Details on test solutions:
At the start and throughout the test the control and the 100 mg/L test solution were observed
to be a clear, colorless solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
The test was carried out using first instar Daphnia magna derived from in-house laboratory cultures.
Adult daphnids were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room maintaining the water temperature at 18 °C to 22 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle
with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension.
Culture conditions ensured that reproduction was by parthenogenesis.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.
pH:
7.7-7.8
Nominal and measured concentrations:
Nominal concentration was 100 mg/L
Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 97% to 99% of the nominal concentration, and so the results are based on the nominal test concentration.
Reference substance (positive control):
yes
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
There was no immobilization in 20 daphnids exposed to a test concentration of 100 mg/L for a period of 48 hours.
No sub-lethal effects of exposure were observed throughout the test.
Results with reference substance (positive control):
The results from the positive control with potassium dichromate were within the normal range for this reference item.
Reported statistics and error estimates:
An estimate of the EC50 values was given by inspection of the immobilization data.
Validity criteria fulfilled:
yes
Conclusions:
Exposure of Daphnia magna to the test item gave EC50 values of greater than 100 mg/L. The No Observed Effect Concentration was 100 mg/L.
Executive summary:

A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing ofChemicals (April 2004) No 202, "Daphniasp., Acute Immobilisation Test" referenced asMethod C.2 of Commission Regulation (EC) No. 440/2008.

Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) wereexposed to an aqueous solution of the test item at a nominal concentration of 100 mg/L for48 hours at a temperature of 19 °C to 22 °C under static test conditions. Immobilization andany adverse reactions to exposure were recorded after 24 and 48 hours.

Analysis of the test preparations at 0 and 48 hours showed measured test concentrations torange from 97% to 99% of the nominal concentration, and so the results are based on thenominal test concentration.Exposure of Daphnia magnato the test item gave EC50values of greater than 100 mg/L. TheNo Observed Effect Concentration was 100 mg/L.

Description of key information

Exposure of Daphnia magna to the test item gave EC50 values of greater than 100 mg/L. The No Observed Effect Concentration was 100 mg/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information