Fatty acids, tall-oil, polymers with glycidyl neodecanoate

Short-term toxicity to aquatic invertebrates

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 August 11, 2015 to December 1, 2015

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)

Analytical monitoring:

yes

Details on sampling:

0 and 48 h

Details on test solutions:

PREPARATION OF TEST SOLUTION
The water-accommodated fractions (WAF) were prepared for the test. This was done by weighing the nominal loads (10.5, 18.3, 33.5, 56.2 and 102.0 mg/L), adding the corresponding amount of dilution water and shaking vigorously for 23.5 h. The resulting solutions were filtrated through 0.45 μm nylon filters.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Species: Daphnia magna.
- Variety: STRAUS.
- Strain: Berlin.
- Sex: Female.
- Origin: Umweltbundesamt Berlin.
- Age at study initiation: between 0 and 24 h.

ANIMAL HUSBANDRY
Vessels: Preserving glasses, nominal volume 2 L.
Medium: M4-Medium (recipe of ELENDT).
Food: Unicellular green algae (Desmodesmus subspicatus).
Medium renewal: Twice a week.
Photo period: 16/8 h, using neon tubes.
Temperature: 20±2°C.

IN-LIFE DATES: From August 31, 2015 to September 03, 2015.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250 mg CaCO3/L

Test temperature:

19.4 - 20.9°C

pH:

Blank-control: 7.8
Test group: 7.7-7.8

Dissolved oxygen:

Blank-control: 8.4 - 8.8 mg/L
Test group: 8.5 - 8.9 mg/L

Nominal and measured concentrations:

0, 10, 18, 32, 56 and 100 mg/L (nominal concentration)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers, nominal volume 50 mL, tall shape
- Feeding: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per blank control (replicates): 4
- Observation: 25 and 48 h
- Lighting: Diffuse lighting

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The dilution water enriched with CaCl2*2H2O, MgSO4*7H2O, NaHCO3 and KCl was used as Daphnia medium during the test. After preparation, the dilution water was aerated, and the pH was adjusted to 7.6.
TEST CONCENTRATIONS
- Test concentrations: 0, 10, 18, 32, 56 and 100 mg/L

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

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

Remarks on result:

other: 95% confidence interval- not determinable

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence interval- not determinable

Results with reference substance (positive control):

Results with reference substance: Valid.
The 24 h EC50 of K2Cr2O7 should lie between 0.6 and 1.7 mg/L.
24 h EC50: 1.6 mg/L

Immobility

In the blank control, none of the Daphnia were immobilised. None of the treatments induced significant immobilisation.

Analytical Determinations

At the start and at the end of the test, the content of the test substance in the test solutions was estimated using measurement of dissolved organic carbon (DOC). Due to the low solubility of the test substance, the measured DOC concentrations in the treatments and in the control were in a similar range. Only in the 3 highest concentrated treatments, the slightly higher measured DOC concentration demonstrates the presence of dissolved test substance in the test solution. Due to the marginal difference of the DOC concentration in the treatments and the control, no test substance concentration was calculated based on the organic carbon content of the test substance and measured DOC concentrations. Therefore, the determination of the biological results was based on the nominal concentration.

VALIDITY OF THE STUDY

- The 24 h-EC₅₀ of K₂Cr₂O₇should lie between 0.6 and 1.7 mg/L. The 24 h-EC₅₀of K₂Cr₂O₇ was determined as 1.6 mg/L in a separate GLP study (15011201R201).

- Immobilisation in the controls may not exceed 10%. Immobilisation in the controls was 0%.

- The concentration of dissolved oxygen at the end of the test must be at least 3 mg/L. The lowest concentration of dissolved oxygen at the end of the test was 8.8 mg/L.

- The pH-value in the test solutions should not vary by more than 1.5 units during the test. The highest variation was 0.1 units.

Validity criteria fulfilled:

yes

Conclusions:

48 h EC50 for exposure of Daphnia was >100 mg/L (nominal) and the corresponding 48 h NOEC was 100 mg/L (nominal).

Executive summary:

An acute toxicity study in Daphnia magna was conducted with the test substance according to OECD Guideline 202 and EU Method C.2, in compliance with GLP. Four replicates of 5 daphnids each were exposed at the nominal concentrations of 0, 10, 18, 32, 56 and 100 mg/L for 48 h in a static test system. The content of substance in the test solutions was estimated by DOC measurement at 0 and 48 h. Due to the low solubility of the test substance, there was marginal difference of DOC content in the control and treatment groups. Therefore, results were based on nominal concentrations. Observations for immobilisation were made 25 and 48 h after the start of exposure. None of the treatments induced significant immobilisation and none of the animals were immobilised in the control group. The 24 h EC50 value of positive control (potassium dichromate) was determined to be 1.6 mg/L, which lies within the required range of 0.6 - 1.7 mg/L. All validity criteria of the study were fulfilled. Under the study conditions, the 48 h EC50 for exposure of daphnids was >100 mg/L (nominal) and the corresponding 48 h NOEC was 100 mg/L (nominal) (Muckle, 2015).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

An acute toxicity study in Daphnia magna was conducted with the test substance according to OECD Guideline 202 and EU Method C.2, in compliance with GLP. Four replicates of 5 daphnids each were exposed at the nominal concentrations of 0, 10, 18, 32, 56 and 100 mg/L for 48 h in a static test system. The content of substance in the test solutions was estimated by DOC measurement at 0 and 48 h. Due to the low solubility of the test substance, there was marginal difference of DOC content in the control and treatment groups. Therefore, results were based on nominal concentrations. Observations for immobilisation were made 25 and 48 h after the start of exposure. None of the treatments induced significant immobilisation and none of the animals were immobilised in the control group. The 24 h EC50 value of positive control (potassium dichromate) was determined to be 1.6 mg/L, which lies within the required range of 0.6 - 1.7 mg/L. All validity criteria of the study were fulfilled. Under the study conditions, the 48 h EC50 for exposure of daphnids was >100 mg/L (nominal) and the corresponding 48 h NOEC was 100 mg/L (nominal) (Muckle, 2015).