Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine

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:

2017-11-20 - 2017-11-24

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:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine

EC Number:

800-003-4

Cas Number:

1415316-96-9

IUPAC Name:

Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine

Test material form:

liquid

Details on test material:

52% active content (solid phase) in water

Specific details on test material used for the study:

Name of test substance: Efka FA 4671
Test substance No.: 16/0408-2
Batch identification: 0016381869
CAS No.: 1415316-96-9
Purity: 100 % UVCB (Substances of Unknown or Variable composition, Complex reaction products or Biological materials),
Content: Solid content 52.0 % (Certificate of Analysis)
Homogeneity: Given visual
Storage stability: Expiry date: 24 Nov 2019
Chemical Name: Fatty acids sunflower oil, conjugated, maleated, reaction products with diethanolamine, maleated tall-oil fatty acids and triethanolamine
Physical state/ Appearance: Liquid, yellowish to brownish, clear

Sampling and analysis

Analytical monitoring:

no

Remarks:

Analyses of the test substance preparations were not conducted since the test substance is an UVCB. No reliable method for analyses in the required concentration range could be developed.

Details on sampling:

Test medium: A synthetic fresh water (Elendt M4) is used as media for culture and test purposes. For the composition of this M4 medium see OECD 202.The general properties of this medium are as follows.
Total hardness: 2.20 – 3.20 mmol/L
Acid capacity up to pH 4.3: 0.80 – 1.00 mmol/L
Molar ratio Ca:Mg: about 4 : 1
pH value: 7.5 – 8.5
Conductivity: 550 - 650 μS/cm
Total organic carbon: <2 mg/L
Dissolved oxygen: Must remain ≥3mg/L during the test. To assure optimal dissolved oxygen levels, the M4 medium is aerated for approximately 24 hours prior to use.
The measured values of these parameters during the experiment are provided in chapter 4.3. Water quality.
Test vessels: Test tubes (glass) sealed with gas impermeable teflon caps. (nominal volume 23 mL)
In order to ensure constant exposure conditions, this study was conducted with a daily test solution renewal and in closed test vessels.
Test volume: approx. 23 mL
Test solution renewal: static-renewal exposure via test water.

T In order to ensure constant exposure conditions, this study was conducted with a daily test solution renewal and in closed test vessels.
Test volume: approx. 23 mL
Test solution renewal: static-renewal exposure via test water.

Due to the volatility / instability of the test substance in the test medium, this study was conducted as a static-renewal. The renewal period was 24 hours.
Test temperature: 19.5 – 20.2°C (continuous monitoring)
Biological loading: 5 animals / test vessel (approx.0.22 animals/mL)
Light intensity / Photo period: About 159 – 691 lux at a wave length of 400-750 nm;
16 hours light : 8 hours darkness
Aeration: none
Diet: No feeding during the exposure period.

Test solutions

Vehicle:

no

Details on test solutions:

Test substance preparation:
The test substance is a multi-component mixture (UVCB), which is designated as miscible with water. The test substance was homogenized by shaking the container before use. The test solution was prepared separately (differential loading) by directly
adding test substance to test medium. The necessary amount of test substance was weighed into a 1 L volumetric flask and filled to the mark with test medium. The solution was then stirred in a closed volumetric flask for approximately 10 min. After 10 minutes of stirring the test substance preparation was turbid with slight formation of foam. The solution was left undisturbed for 24 hours to allow separation of the undissolved material. The aqueous fraction was inspected visually for the presence of any undissolved test substance by observing the scattering of a laser light through the test solution (Tyndall effect). The substance was visible as flakes with foam at the surface. The aqueous fraction was drawn off for testing.
The aqueous phase of the tested concentrations was slightly turbid (slight positive Tyndall effect) at the start of the exposure phase. After 24 hours undissolved test substance/particulate material was visible at the bottom of the test vessels.
Fresh test solutions were prepared daily.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Animal supplier: The clone of Daphnia magna STRAUS 1820 used in this study was originally obtained from the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory of Ecotoxicology of the Experimental Toxicology and Ecology of the BASF SE, Ludwigshafen, Germany.
Culture conditions: Daphnia brood stock are kept in mass cultures consisting of approx. 20 – 30 parthenogenetically reproducing females for a maximum of 4 weeks and fed live unicellular algae (Desmodesmus subspicatus), cultured continuously at the test
facility. All individuals in each mass culture originate from a single female and are thus genetic clones. After approximately 14 days the adults have produced at least 3 broods and the young can be used in tests. Offspring are removed from the
mass cultures at least once daily during the normal work week to ensure that young daphnia are <24-h old (first instar) at start of the exposure. Detailed records are kept (in test facility archives) to monitor the health of Daphnia brood stock cultures
including observations of young production, mortality, ephippia, and measurement of water chemistry parameters. Only young from healthy cultures without signs of stress are used for testing.
Acclimatization:
The Daphnia are cultured under the identical conditions as the test including test media (Elendt M4), water quality, and temperature (20 ±1°C). age at start of exposure: <24 hours (at least 3rd brood progeny)

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Total hardness: 2.4 mmol/L

Test temperature:

19.5 – 20.2°C (continuous monitoring)

pH:

8

Dissolved oxygen:

7.3 - 9.3 mg/L

Conductivity:

Conductivity: 575 μS/cm

Nominal and measured concentrations:

loading rate: 192 mg/L corresponds to 100 mg/L solid content = active substance

Details on test conditions:

The test substance is a multi-component mixture (UVCB), which is designated as miscible with water. The test substance was homogenized by shaking the container before use. The test solution was prepared separately (differential loading) by directly adding test substance to test medium.
192 mg test substance was weighed into a 1 L volumetric flask and filled to the mark with test medium. The solution was then stirred in a closed volumetric flask for approximately 10 min. After 10 minutes of stirring the test substance preparation was turbid with slight formation of foam. The solution was left undisturbed for 24 hours to allow separation of the undissolved material. The aqueous fraction was inspected visually for the presence of any undissolved test substance by observing the scattering of a laser light through the test solution (Tyndall effect). The substance was visible as flakes with foam at the surface. The aqueous fraction was drawn off for testing.The aqueous phase of the tested concentrations was slightly turbid (slight positive Tyndall effect) at the start of the exposure phase. After 24 hours undissolved test substance/particulate material was visible at the bottom of the test vessels. Fresh test solutions were prepared daily. The test solution after separation of the undissolved material is considered a water accommodated fraction (WAF). According to OECD 23 [Ref. 7], the term “loading rate” should be used to express exposure to a WAF and is considered analogous to the nominal
concentration.

The exposure was started by impartially distributing 20 neonate (< 24 hours old) Daphnia magna evenly among the 4 test vessels per test group. The neonate daphnids all originated from the same mass culture and were thus genetic clones (see chapter 3.2). The Daphnia were transferred into the test vessels with minimal culture water by capturing each daphnid in a pipette then gently expelling it onto a Teflon mesh (70 μm) held by forceps. Each daphnid was then immediately transferred from the mesh into the corresponding test vessel. The test vessels were maintained as described in chapter 3.3. Each test vessel was visually checked for immobilized daphnids after 0, 24 and 48 hours. In addition any abnormal behavior or appearance was documented.
For test renewal, daphnids in each replicate were captured with a pipette and transferred into test vessels with fresh test solution.
Throughout the test, the appearance of the test solutions and dissolution behavior of the test substance was observed and recorded daily in old and new test solutions. The chemical and physical parameters of the test medium (total hardness, acid capacity, pH, TOC and conductivity) were determined after aeration and prior to use in the test. The pH and dissolved oxygen content of the test solutions was measured after 0h and 24h (new test solutions) in an additional replicate without daphnids and after 24 h and 48 h (old test solutions) in replicate 1 of the tested concentration and the control.

Reference substance (positive control):

yes

Remarks:

Sodium chloride

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

192 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: loading rate

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Remarks on result:

other: loading rate

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

Daphnia (daphnia magna) were exposed for 48 h under semi-static conditions towards the test item according to OECD 202 criteria. The EC50 was determined to be 192 mg/L test item corresponding to 100 mg/L acitve substance. All validity criteria were fulfilled.