Fatty acids, vegetable-oil, Me esters, sulfurized

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

FROM 15 OCT 2018 TO 30 NOV 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

The temperature for the study ranged from 20.4 to 22.8 °C and therefore higher than stated in the Guideline and fluctuated by more than 2°C. The deviation was only short due to the relocation of the data logger.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, vegetable-oil, Me esters, sulfurized

EC Number:

276-337-4

EC Name:

Fatty acids, vegetable-oil, Me esters, sulfurized

Cas Number:

72102-30-8

IUPAC Name:

Fatty Acids, vegetable-oil, Me-Esters, sulfurized

Test material form:

liquid

Details on test material:

- Density: 0.95 g/mL
- Batch no.: 71012767

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The water-accommodated fraction (WAF) was prepared for the test. This was done by mixing of 100.1 mg/L resp. 105.4 μL/L test item (based on a density of 0.95 g/mL stated in the SDS) with the corresponding amount of dilution water and stirring moderately for 24 hours. The lower phase was used unfiltered as test solution. The same preparation procedure was used for the medium renewal. For this solution the WAF was stirred for 23 hours 30 minutes.
- Controls: At the start and at the end of the test, the content of the test item in the test solutions was determined using GC/MSD.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): not stated

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Berlin
- Age at study initiation (mean and range, SD): between 0 and 24 hours
- Stage and instar at study initiation: newborn daphnia
- Method of breeding: in-house breeding
- Source: LAUS GmbH
- Feeding during test: not stated

ACCLIMATION
- Acclimation period: not stated

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS:

The husbandry is performed similar to the method described in the OECD guideline, following SOP 115 002 01 („Zucht und Hälterung von Daphnia magna STRAUS“), version 12 from 02. Feb. 2015.
Vessels preserving glasses, nominal volume 2 L
Medium M4-Medium (recipe of ELENDT)
Food green algae (Desmodesmus subspicatus)
Medium renewal twice a week
Photo period 16/8 hours, using neon tubes
Temperature 20 ± 2 °C

21 hours before the start of the test, the adult animals were separated from the young. 40 minutes before test start, the adults were caught with the help of a glass tube, and the newborn daphnia, aged between 0 and 21 hours, were sieved from the medium and immediately placed into a beaker containing dilution water. After the settling-in period, animals which showed no apparent damage were used for the test.
Switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test daphnia.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Hardness in mmol/L: 2.502

Test temperature:

20.4 – 22.8 °C

pH:

pH-values
Nominal Concentration 0 h 24 h 24 h 48 h
in mg/L old new
Blank control 7.7 7.8 7.8 7.8
100 7.7 7.9 7.9 7.9

Dissolved oxygen:

O2-Concentration in mg/L
Nominal Concentration 0 h 24 h 24 h 48 h
in mg/L old new
Blank control 8.9 9.0 9.2 8.5
100 8.9 8.8 8.9 8.6

Conductivity:

not stated

Nominal and measured concentrations:

100 mg/L nominal concentration

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers
- Type: open
- Material, size, headspace, fill volume: glass, nominal volume 100 mL, tall shape
- Volume of solution: 50 ± 5 mL
- Aeration: no
- Renewal rate of test solution: renewal was performed after 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionised water with an enrichment of certain minerals (following SOP 11800201) was used in the test.
- Total organic carbon: not stated
- Culture medium different from test medium: yes

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: not stated
- Light intensity: not stated

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Daphnia are considered immobilised if they perform no movements or are only able to move their antennae when the beaker is gently agitated. Observation times 24 and 48 hours.

Reference substance (positive control):

yes

Remarks:

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

Results and discussion

Effect concentrations

Effect concentrations 1

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

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

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

Effect concentrations 4

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:

- Behavioural abnormalities: no behavioural abnormalities reported
- Observations on body length and weight: not reported
- Other biological observations: not reported
Other adverse effects control: no adverse effects of control reported
- Immobilisation of control: 1/20
- Abnormal responses: no abnormal responses reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: yes

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study (201714R201). The 24h-EC50i value was determined as 1.9 mg/L.
The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium dichromate K2Cr2O7 as specified in the OECD guideline. Since the fits showed sufficient statistical correspondence of the data with the dose-response-equation, this reference study can be considered valid.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The study was performed as a limit test at 100 mg/L. For the test concentration and the blank control, 20 Daphnia were exposed to the test item for 48 hours in a semi-static test system. After 24 and 48 hours, the immobilised Daphnia were counted. Because the test item is not stable under test conditions the study was performed under semi-static conditions.
The treatment showed no toxicity/mortality. One of the animals was immobilised in the blank control. Therefore no statistical evaluation was performed.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.
At the start and at the end of the test, the content of the test item in the test solutions was determined using GC/MSD.
At the beginning of the test the test item was still detectable in small quantities. No test item was detectable after 24 h and 48 h incubation. Since the test item was stirred and therefore could not be removed from the solution by filtration, test item was definitely present in the solution.
Therefore, the results are related to the nominal values.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.
No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.