Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

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:

2016-12-07 to 2017-03-08

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)

Qualifier:

according to guideline

Guideline:

other: OECD Series on Testing and Assessment, No. 23, "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures"

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the start of the test.
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the test media of all test concentrations and the control were collected at the end of the test (after 48 hours) by pouring together the contents of the test beakers of each treatment.
Additional samples of the control were taken at test start and test end without any sample treatment.

Vehicle:

no

Details on test solutions:

Concentrations of nominal 100, 45.5, 20.7, 9.4 and 4.3 mg/L and a control were tested.
Each concentration was prepared by dissolving test substance in test water and filtration.
Corresponding to mean measured concentrations of 44.2, 24.1, 14.6, 9.07 and 5.06 mg test item/L.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna (Straus), clone 5
Age at Test Start: From 1.0 to 18.5 hours old
Sex: Female
Origin: The Daphnia introduced in the test were taken from ibacon's in house laboratory culture.

The daphnids were bred in the laboratories of ibacon under similar temperature and light conditions as used in the test. The cultivation of the parental daphnids was performed in Elendt M4 medium. The test organisms were not first brood progeny. The daphnids in the stock culture were fed at least on all working days with green algae (Desmodesmus subspicatus) freshly grown in the laboratories of ibacon.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

Water Hardness: 2.5 mmol/L (= 250 mg/L) as Calcium Carbonate

Test temperature:

19 to 22 °C at test start;
19 °C at test end

pH:

7.9 to 8.1 at test start;
7.7 to 7.8 at test end; and thus the pH-value did not vary by more than 1.5 units

Dissolved oxygen:

8.3 to 8.9 mg/L at test start;
8.5 to 8.9 mg/L at test end

Nominal and measured concentrations:

Concentrations of nominal 100, 45.5, 20.7, 9.4 and 4.3 mg/L and a control were tested.
Corresponding to mean measured concentrations of 44.2, 24.1, 14.6, 9.07 and 5.06 mg test item/L.

Details on test conditions:

Test Environment: Controlled environment room
Measurement of pH, Dissolved
Oxygen and Water Temperature:
The water temperature, pH-values and dissolved oxygen concentrations were determined at test start and test end in each treatment group.
Water Temperature:19 to 22 °C at test start; 19 °C at test end
pH-Values: 7.9 to 8.1 at test start;
7.7 to 7.8 at test end; and thus the pH-value did not vary by more than 1.5 units
Dissolved Oxygen Concentration: 8.3 to 8.9 mg/L at test start;
8.5 to 8.9 mg/L at test end
Light Regime: 16 h light : 8 h dark
Light Intensity: The light intensity was 200 to 710 lux (measured once during the test).

Reference substance (positive control):

yes

Remarks:

For the evaluation of the quality of the Daphnia clone and the consistency of the experimental conditions, the reference item potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 26 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

24.1 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

26 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

After 48 hours of exposure no immobilisation of the test animals was observed in the control and up to and including the test item concentration of 14.6 mg test item/L. At the concentration of 24.1 mg test item/L, one animal was immobile and 20 animals were immobile at the concentration of 44.2 mg test item/L.

Results with reference substance (positive control):

In the most recent test with the reference item potassium dichromate the EC50 after 24 hours was determined to be 0.959 mg test item/L, indicating that the sensitivity of the daphnids was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).

Reported statistics and error estimates:

For the highest test concentration the mean measured value was used for the statistical analyses. In the results all values above the water solubility were determined to be above the water solubility limit (26 mg/L).The 24-hour and 48-hour EC50, EC20 and EC10 and the 95 % confidence limits were calculated by probit analysis.
The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.

Validity criteria fulfilled:

yes

Remarks:

Control Immobilisation Rate:Was 0 % and furthermore no daphnid showed signs of disease or stress Dissolved Oxygen Concentration:Was >= 8.5 mg O2/L in the control and test vessels at the end of the test. The validity criteria were met.

Conclusions:

48h-EC50 (Daphnia magna, immobility) > 26 mg/L (above water solubility); 48h-NOEC (Daphnia magna, immobility) = 24.1 mg test item/L; 48h-LOEC (Daphnia magna, immobility) = 26 mg test item/L (mean measured)

Executive summary:

The purpose of this study was to determine the influence of the test item Hostastat FE 20 LIQ on the mobility of Daphnia magna.For this purpose, young daphnids (< 24 hours old) were exposed in a static test to various concentrations under defined conditions for 48 hours. The recorded effects were the mobility of the daphnids after 24 and 48 hours.The test method of application and the test system are recommended by the test guidelines and Daphnia magna is the recommended test species.The purpose of the analytical part of this study is to verify the concentrations of the test item in the test medium.

Guidelines:

Commission Regulation (EC) No 440/2008, Annex, Part C, C.2.: "Daphnia sp. Acute Immobilisation Test", Official Journal of the European Union (EN), dated May 30, 2008

OECD Guideline for Testing of Chemicals No. 202: "Daphnia sp., Acute Immobilisation Test" adopted April 13, 2004

OECD Series on Testing and Assessment, No. 23, "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures", December 15, 2000

SANCO/3029/99 rev.4 11/07/00: Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (part A; Section 4) and Annex III (part A; Section 5) of directive 91/414

 

Material and Methods

Test Item: Hostastat FE 20 LIQ; batch no.: ESD0021912; purity: 100 % (w/w), according to certificate of analysis

Test Species: Daphnia magna, clone 5; 1.0 to 18.5 hours old

Source: The daphnids introduced in the test were taken from ibacon's in-house laboratory culture.

Test Design: This study encompassed 6 treatment groups (5 dose rates of the test item and a control) each containing 20 individuals. The mobility of the daphnids was determined in a static 48-hour test by visual observation after 24 and 48 hours.

Endpoints: Number of immobile organisms after 24 and 48 hours

Test Concentrations: Concentrations of nominal 100, 45.5, 20.7, 9.4 and 4.3 mg/L and a control were tested.

Each concentration was prepared by dissolving test substance in test water and filtration.

Corresponding to mean measured concentrations of 44.2, 24.1, 14.6, 9.07 and 5.06 mg test item/L. The highest concentration is above the water solubility (26 mg test item/L).

Test Conditions: Water temperature: 19 to 22 °C; pH value: 7.7 to 8.1; dissolved oxygen concentration: 8.3 to 8.9 mg/L; photoperiod: 16 h light - 8 h dark; light intensity: 200 to 710 lux.

Results

Biological test results: After 48 hours of exposure no immobilisation of the test animals was observed in the control and up to and including the test item concentration of 14.6 mg test item/L. At the concentration of 24.1 mg test item/L, one animal was immobile and 20 animals were immobile at the concentration of 44.2 mg test item/L.

Five % immobilisation at the concentration of 24.1 mg test item/L concentration are not considered as an effect, According to the validity criteria of the guideline, up to 10 % mortality is accepted in the controls and therefore can be expected as coincidental.

Conclusion: The toxic effect of the test item Hostastat FE 20 LIQ to Daphnia magna was assessed in a static concentration-response test. The 48-hour NOEC was determined to be 24.1 mg test item/L. Taking into account the water solubility of the substance (26 mg/L), the immobilization rate of 100 % at the highest concentration is clearly above the water solubility and cannot be used for the toxicity assessment.The 48-hour LOEC was determined to be 26 mg test item/L (above water solubility) and the 48-hour EC50 value was calculated to be > 26 mg test item/L (above water solubility). The quantification of the test item Hostastat FE 20 LIQ in the test samples was performed by analysing the Total Organic Carbon content (TOC).

This study was classified as acceptable and satisfied the guideline requirements for an acute toxicity study with freshwater invertebrates.

Description of key information

48 h-EC50 (Daphnia magna, immobility) > 26 mg/L (above water solubility); 48h-NOEC (Daphnia magna, immobility) = 24.1 mg test item/L; 48h-LOEC (Daphnia magna, immobility) = 26 mg test item/L (mean measured, OECD 202, 2017)

Note: The key value was inserted in order to enable the application of the PNEC calculator. The inserted concentration is higher than the effect concentration used as basis for the PNEC derivation and therefore does not bias the PNEC calculation performed by the PNEC calculator.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

26 mg/L

Additional information

In a reliable key study, acute toxicity of the submission substance on the mobility of Daphnia magna was investigated (RL1). Young daphnids were exposed to five test concentrations (nominal 100, 45.5, 20.7, 9.4 and 4.3 mg/L) for 48 hours in a static test. The test concentrations were analytically verified by analysing the Total Organic Carbon content (TOC). A control was run in parallel.

After 48 hours of exposure no immobilisation of the test animals was observed in the control and up to and including the test item concentration of 14.6 mg test item/L. One animal was immobile at test concentration of 24.1 mg test item/L (5% effect), and 20 animals were immobile at 44.2 mg test item/L test concentration. Effects occurred in a dose-response relationship. Reported effect concentrations refer to mean measured concentrations: 46h-EC50 (Daphnia magna, immobility) > 26 mg/L (above water solubility); 48h-NOEC (Daphnia magna, immobility) = 24.1 mg test item/L; 48h-LOEC (Daphnia magna, immobility) = 26 mg test item/L.

This study was classified acceptable and satisfied the guideline requirements for fish acute test studies. In conclusion, the test was considered reliable and adequate for the environmental hazard assessment for aquatic organisms.