Esterification product of sunflower-oil fatty acids, with 1,4:3,6-dianhydro-D-glucitol

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 07/12/2018 to 09/12/2018

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

(EU) 2017/735 of 14 February 2017

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Adopted 13 April 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Remarks:

There is no suitable analytical method to measure the test item in the ISO medium.

Details on sampling:

There was no sampling since the test item cannot be measured in the ISO medium.

Vehicle:

no

Details on test solutions:

Saturated test item solution, 100 mg/L nominal loading rates (WAF) was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the test. This solution was stirred (slow stirring using magnetic stirrer) for about 48 hours at test temperature and then equilibrated for about 2 hours at the same temperature. Afterwards the WAF was taken from the homogeneous liquid phase (the approximate centre of the glass flask) and then this solution was filtered through a fine (0.22 µm) sterile filter. The filtered solution was used for the test.
Prior to treatment of each renewal period, test item solution was prepared by the method described above.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: István Szent University, 2100 Gödöllő, Páter Károly u. 1, Hungary
- Age of parental stock (mean and range, SD): less than 24 h old at the beginning of the test
- Feeding during test : no

ACCLIMATION
- Acclimation period: no acclimatization because the water used was similar to the culture water
- Breeding : The Daphnia are bred in Ecotoxicological Laboratory of Citoxlab Hungary Ltd. The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

246 mg/L (as CaCO3) of the reconstituted water (ISO medium)

Test temperature:

Between 20.7 – 20.9°C measured at the start and at the end of the renewal periods in each test vessel.

pH:

Between 7.58 – 7.91 measured at the start and at the end of the renewal periods in each test vessel.
The pH was not increased by more than 1.5 during the test.

Dissolved oxygen:

Between 7.1 – 8.6 mg/L measured in each test vessel at the start and at the end of the renewal periods

Salinity:

Irrelevant

Conductivity:

Not reported

Nominal and measured concentrations:

Nominal concentration is 100 mg/L nominal loading rate WAF.
Measured concentration : despite all efforts made to improve the analytical method, it has not been possible to measure the test item in the ISO medium. The sensitivity of the analytical method was not enough in view of the poorly solubility of the test item in this aquatic medium.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker of 50 ml
- Type: open
- Material, size, headspace, fill volume: ~40 ml test solution / vessel
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): every 24h
- No. of organisms per vessel: 5 animals /vessel
- No. of vessels per concentration (replicates): 4 replicates
- No. of vessels per control (replicates): 4 replicates
- Biomass loading rate: not reported

TEST MEDIUM : ISO medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light and 8h dark
- Light intensity: not reported

EFFECT PARAMETERS MEASURED : immobility or mortality of Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile

RANGE-FINDING STUDY
- Test concentrations: 0.1; 1; 10 and 100 mg/L nominal loading rates WAF.
- 10 daphnids (2 replicates/ concentration) exposed for 48h in semi-static conditions.
- Results used to determine the conditions for the definitive study: no immobilisation at any of the tested concentrations.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate is tested at least twice a year.

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

Potassium dichromate : 24h EC50: 0.71 mg/L, (95 % confidence limits: 0.66 – 0.76 mg/L) tested 19- 20 June 2018.

Test Group	Number of treated animals	Number of immobilised animals
		24 hours		48 hours
		number	percent	number	percent
Control	20	0	0	0	0
100 mg/L nominal loading rate WAF	20	0	0	0	0

 

Validity criteria fulfilled:

yes

Remarks:

No immobilisation of Daphnids in the control (validity if ≤ 10%) and dissolved oxygen concentrations at the end of the test in control and test vessels are ≥ 7.1 mg/L (validity if ≥ 3 mg/L).

Conclusions:

No immobilisation was observed on Daphnia magna following 48h of exposure to 100 mg/L nominal loading rate WAF, in semi-static conditions. The 48h-NOELR ≥ 100 mg/L nominal loading rate WAF.

Executive summary:

The acute toxicity of the substance "Esterification products of 1,4:3,6-dianhydro-D-glucitol with sunflower oil fatty acids" to Daphnia magna was determined according to the EU method C.2 and OECD 202, in compliance with the GLP.

20 daphnids distributed in four vessels were exposed during 48 h to 100 mg/L nominal loading rate WAF in a semi-static test. Since no toxicity was observed in a preliminary range finding test, a limit test was carried out using only one concentration and one control group.

Despite all efforts made to improve the analytical method, it has not been possible to measure the test item in the ISO medium. The sensitivity of the analytical method was not enough in view of the poorly solubility of the test item in the aquatic medium. Therefore no analytical control was performed and the results are expressed as nominal concentration.

In accordance with the OECD guidance document No. 23 on "Aquatic Toxicity Testing of Difficult Substances and Mixture", a saturated test item solution, 100 mg/L nominal loading rate (WAF), was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the test. This solution was stirred (slow stirring using magnetic stirrer) for about 48 hours at test temperature and then equilibrated for about 2 hours at the same temperature. Afterwards the WAF was taken from the homogeneous liquid phase (the approximate centre of the glass flask) and then this solution was filtered through a fine (0.22 µm) sterile filter. The filtered solution was used for the test. At the renewal period, a new test item solution was prepared by the same method.

No immobilisation of Daphnia magna was observed following the 48h of exposure to 100 mg/L nominal loading rate WAF. So the 48h EL50 value is > 100 mg/L nominal loading rate WAF, and the 48h No-Observed Effect Loading Rate (NOELR) ≥ 100 mg/L nominal loading rate WAF. Based on these results, the substance "Esterification products of 1,4:3,6-dianhydro-D-glucitol with sunflower oil fatty acids" is considered to have no adverse effect to Daphnids in the test conditions.

This acute toxicity test to Daphnia magna is acceptable, and satisfies the requirements of the EU Method C.2 and the OECD 202.

Description of key information

No immobilisation was observed on Daphnia magna following 48h of exposure to 100 mg/L nominal loading rate WAF, in semi-static conditions. The 48h-NOELR ≥ 100 mg/L nominal loading rate WAF.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

The acute toxicity of the substance "Esterification products of 1,4:3,6-dianhydro-D-glucitol with sunflower oil fatty acids" to Daphnia magna was determined according to the EU method C.2 and OECD 202, in compliance with the GLP.

20 daphnids distributed in four vessels were exposed during 48 h to 100 mg/L nominal loading rate WAF in a semi-static test. Since no toxicity was observed in a preliminary range finding test, a limit test was carried out using only one concentration and one control group.

Despite all efforts made to improve the analytical method, it has not been possible to measure the test item in the ISO medium. The sensitivity of the analytical method was not enough in view of the poorly solubility of the test item in the aquatic medium. Therefore no analytical control was performed and the results are expressed as nominal concentration.

In accordance with the OECD guidance document No. 23 on "Aquatic Toxicity Testing of Difficult Substances and Mixture", a saturated test item solution, 100 mg/L nominal loading rate (WAF), was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the test. This solution was stirred (slow stirring using magnetic stirrer) for about 48 hours at test temperature and then equilibrated for about 2 hours at the same temperature. Afterwards the WAF was taken from the homogeneous liquid phase (the approximate centre of the glass flask) and then this solution was filtered through a fine (0.22 µm) sterile filter. The filtered solution was used for the test. At the renewal period, a new test item solution was prepared by the same method.

No immobilisation ofDaphnia magnawas observed following the 48h of exposure to 100 mg/L nominal loading rate WAF. So the 48h EL50 value is > 100 mg/L nominal loading rate WAF, and the 48h No-Observed Effect Loading Rate (NOELR) ≥ 100 mg/L nominal loading rate WAF. Based on these results, the substance "Esterification products of 1,4:3,6-dianhydro-D-glucitol with sunflower oil fatty acids" is considered to have no adverse effect to Daphnids in the test conditions.