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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:
2018
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
Qualifier:
equivalent or similar to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Name: 9-Octadecenoic acid (9Z)-, propyl ester
Product Description: Propyl oleate
CAS No.: 111-59-1
Physical state: pale yellow to yellow liquid at 20 °C
Batch No.: 37584
Re-certification date of batch: 08 March 2018
Purity: > 99 % (fatty acid propyl esters, max water content 0.3 % (w/w))
Free Fatty Acid, % Oleic: 0.1
Color, Gardner: 3
Iodine Value, cg I2/g 75
Cloud Point, degrees C 0
Saponification Number, mg KOH/g 177
Moisture, % 0,07
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Analytical monitoring:
yes
Remarks:
HPLC method
Details on sampling:
Chemical analysis of the test item to determine exposure concentration and stability of the test item during test duration was performed at the test site biochemA, Im Oberwald 19b, D-79359, Riegel a.K., Germany. Samples were taken in 2 replicates from the test concentrations (A, B, C, D and E) and the control (NC) at 0 h, 24 h (before/after renewal) and 48 h from the separate test vessels without daphnids. For stabilisation 4 ml acetonitril was submitted in 8 mL glass vials. With every sampling 1 mL of the test solution was taken and filled into the glass vials. This resulted in a dilution of test solution by factor 5. The samples were kept in the freezer at < -18°C. After the experimental phase one replicate of every sampling was sent to the analytical laboratory. The second replicate was kept in the freezer as retain sample until finalization of the study. Proper departure and arrival of the samples was documented.

The sampling and documentation was conducted according to the following specification:
- After 0 h exposure, two replicates per treatment group of NC, A (6.25 mg/l), B (12.5 mg/l), C 25 mg/l, D (50 mg/l) and E (100 mg/l) are sampled;
- After 24 h exposure:
Before renewal of the test solutions, two replicates per treatment group of NC, A, B, C, D and E are sampled. After renewal of the test solutions, two replicates per treatment group of NC, A, B, C, D and E are sampled.
- After 48 h exposure, two replicates per treatment group of NC, A, B, C, D and E are sampled
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
The test organism Daphnia magna Straus originates from the clone breeding of the Federal Environment Agency, department IV 2.4, Berlin, and was cultivated at Hydrotox GmbH since October 2012. The daphnids are cultured at 20  2 °C with 16 h light : 8 h dark and placed into fresh M4 medium twice a week. They are kept at approx. 10 animals / 200 mL and fed on workdays with Desmodesmus subspicatus algae corresponding to 0.1 mg C × daphnid-1 × day-1. The test organisms used were 3.25 – 22.5 h old at the start of the test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
The test was performed with M4 medium according to OECD 202 (2004).
Test temperature:
The temperature during the exposure was 19.9 – 21.0 °C (required 18 - 22 °C, constant within  1 °C).
pH:
The pH was 7.3 – 8.2 in the control and 7.5 – 8.3 in the test item treatments.
Dissolved oxygen:
The dissolved oxygen concentration was 7.2 – 8.5 mg/L in the control and 7.7 – 8.5 mg/L in the test item treatments.
Salinity:
The test was performed with M4 medium according to OECD 202 (2004).
Conductivity:
A conductivity of 694/676 µS/cm was determined for the test medium.
Nominal and measured concentrations:
The measured test item concentrations in the test item treatments were below detection limit of the substance. Hence nominal load rate concentrations were used.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
Quality assurance takes place at regular intervals by testing the sensitivity of the test organisms to the reference item potassium dichromate (Sigma, Steinheim, Germany; Lot no.: MKBF2111V, expiration date: January 2019). The recent quality testing was performed in October 2017 with EC50 = 1.77 mg/l (1.63 – 2.05 mg/L Cl-95%) (24 h) which is in the declared range of 0.6 - 2.1 mg/L (24 h) according to OECD 202.
Reported statistics and error estimates:
The effect occurrence after 24 h and 48 h exposure was calculated. With the statistical software ToxRat Professional 2.10.05 (ToxRat Solutions GmbH, Alsdorf, Germany), EC and LOEC/NOEC were determined as far as mathematically possible.

Results

The Daphnia magna acute immobilisation test was performed with five loading rates between 6.25 mg/L and 100 mg/L. The insolubility of the test item, resulting in no detection of the test item. Therefore all results are given in relation to the nominal test item concentrations. The test is valid according to OECD Test Guideline 202 (13 April 2004). Substance-specific chemical analysis was based on the detection of the test item, which has a purity of 100%. In the control, the test item was not detected. In all test item treatments the test item was below the Limit of Detection (LOD = 0.0310 mg/L).

Effect concentrations

The effect concentrations after 24 h and 48 h exposure were calculated with the statistical software ToxRat Professional 3.2.1 (Table 3; Appendix II). Because the measurements of the chemical analysis were below the limit of detection, it is not feasible to conduct the data evaluation based on the measured test item concentrations. Therefore all results are given in relation to the nominal test item concentrations.

Test parameters

- The pH was 7.3 – 8.2 in the control and 7.5 – 8.3 in the test item treatments.

- The dissolved oxygen concentration was 7.2 – 8.5 mg/L in the control and 7.7 – 8.5 mg/L in the test item treatments.

- The temperature during the exposure was 19.9 – 21.0 °C (required 18 - 22 °C, constant within +- 1 °C).

 Criteria of validity

- Immobilisation of the test organisms in the control at the end of the test was 0 % and therefore ≤ 10 %.

- Dissolved oxygen concentrations at the end of the test in the control and the test item treatment were ≥ 7.2 mg/L and therefore ≥ 3 mg/L.

Validity criteria fulfilled:
yes
Conclusions:
The Daphnia magna acute immobilisation test was performed with five loading rates between 6.25 mg/L and 100 mg/L of the test item. The following results were obtained: ELR50 (48 h) > 100 mg/L and NOELR (48 h) >= 100 mg/L.
Executive summary:

The Daphnia magna acute immobilisation test was performed with five loading rates between 6.25 mg/L and 100 mg/L of the test item. The insolubility of the test item, resulting in no detection of the test item. Therefore all results are given in relation to the nominal test item concentrations. The test is valid according to OECD Test Guideline 202 (13 April 2004). The following results were obtained: ELR50 (48 h) > 100 mg/L and NOELR (48 h) >= 100 mg/L.

Description of key information

The Daphnia magna acute immobilisation test was performed with five loading rates between 6.25 mg/L and 100 mg/L of the test item. The following results were obtained: ELR50 (48 h) > 100 mg/L and NOELR (48 h) >= 100 mg/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information