Linseed oil, ester with pentaerythritol

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 November 07, 2017 to November 16, 2017

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 substance name: linseed oil, ester with pentaerythritol
Batch no.: 16.343.096
Appearance: yellow liquid
Composition :100% UVCB,
Purity 100% as the substance is an UVCB
Homogeneity: homogeneous
Storage Room Temperature (20 ± 5°C), after opening keep under inert gas

Analytical monitoring:

yes

Details on sampling:

At the beginning and at the end of the test

Vehicle:

yes

Details on test solutions:

The water-accommodated fractions (WAFs) were prepared. As the test substance is a clear liquid with a density lower than water, this was done by mixing the nominal load of 10/ 4.6/ 2.2/ 1/0.46 g/L resp. 10.5/4.8/2.3/1.1/0.48 mL/L test substance (based on a density of 0.95 g/mL determined in LAUS study 17030201G912) with the corresponding amount of dilution water and stirring for 7 d. The lower aqueous phase was used as test solution.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: Umweltbundesamt, Berlin
- Strain: Berlin
- Sex: female
- Age of parental stock (mean and range, SD): between 0 and 24 h
- Feeding during test: No
- Food type: unicellular green algae (Desmodesmus subspicatus)
- Medium renewal twice a week
- Photo period: 16/8 h, using neon tubes
- Temperature 20 ± 2 °C

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Hardness:

CaCO3: 250 mg/L

Test temperature:

20 ± 2 °C

pH:

7.8

Dissolved oxygen:

9.2 mg/L

Nominal and measured concentrations:

460, 1000, 2200, 4600 and 10000 mg/L nominal concentration
18, 28, 32, 43 and 66 mg/L geometric mean measured concentrations

Details on test conditions:

Treatments: 460, 1000, 2200, 4600 and 10000 mg/L nominal concentration
Temperature: 20.7 – 21.7 °C
Duration: 48 h
Observation times: 24 and 48 h
Medium renewal: none
Test vessels: glass beakers, nominal volume 50 mL, tall shape
Replicates (Treatments) 4 vessels, each containing 20 ± 5 mL test solution and 5 daphnia
Replicates (Blank control) 4 vessels, each containing 20 ± 5 mL dilution water and 5 daphnia

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 66 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 66 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

20 daphnia were exposed to the test substance for the treatment for 48 h in a static test system. The concentrations showed no significant toxicity. None of the animals was immobilised in the blank control. At the beginning and at the end of the test, the content of the test substance in the test solutions was determined using DOC-determination. The correlation of the measured concentrations was weak because of the high loading rates and the limited solubility of the test substance. Therefore, the determination of the biological results was based on the geometric mean of the measured concentrations.

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in study to assure that the test conditions are reliable. For the estimation of the EC50 of the positive control, the fit showed sufficient statistical correspondence of the data with the dose-response-equation.

Immobility:

Nominal Concentration in g/L	Immobility 24 hours					Immobility 48 hours
	absolute				in %	absolute				in %
Blank control	0	0	0	0	0	0	0	0	0	0
0.46	0	0	0	0	0	0	0	0	0	0
1	0	0	0	0	0	0	0	0	1	5
2.2	0	0	0	0	0	0	0	0	0	0
4.6	0	0	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 48 h EC50 in Daphnia magna was determined to be > 66 mg/L (measured).

Executive summary:

A study was conducted to determine the short-term toxicity of the test substance to Daphnia magna according to OECD Guideline 202 and EU Method C.2, in compliance with GLP. Water-accommodated fractions (WAFs) were prepared for the study. As the test substance was a clear liquid with a density lower than water, this was done by mixing the nominal load of 0.46/2.2/4.6/10 g/L resp. 0.48/1.1/2.3/4.8/10.5 mL/L test substance. Daphnia magna were exposed to a series of concentrations (460, 1000, 2200, 4600 and 10000 mg/L nominal concentration) for 48 h. Total organic carbon (TOC) was measured with a TOC analyser and the test substance was considered stable over the duration of the study. No immobilised animal was reported in the test and control groups. Under the study conditions, the 48 h EC50 in Daphnia magna was determined to be >66 mg/L (measured) (Muckle, 2018).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

66 mg/L

Additional information

Linseed oil, ester with pentaerythritol

A study was conducted to determine the short-term toxicity of the test substance to Daphnia magna according to OECD Guideline 202 and EU Method C.2, in compliance with GLP. Water-accommodated fractions (WAFs) were prepared for the study. As the test substance was a clear liquid with a density lower than water, this was done by mixing the nominal load of 0.46/2.2/4.6/10 g/L resp. 0.48/1.1/2.3/4.8/10.5 mL/L test substance. Daphnia magna were exposed to a series of concentrations (460, 1000, 2200, 4600 and 10000 mg/L nominal concentration) for 48 h. Total organic carbon (TOC) was measured with a TOC analyser and the test substance was considered stable over the duration of the study. No immobilised animal was reported in the test and control groups. Under the study conditions, the 48 h EC50 in Daphnia magna was determined to be > 66 mg/L (measured) (Muckle, 2018).