Fatty acids C16-18 (even numbered), mono, di and tri esters with sucrose

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:

December 28, 2015 - March 6, 2016

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)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mitsubishi-Kagaku Foods Corporation, Lot # 55033111

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions in the dark.
- Solubility and stability of the test substance in the solvent/vehicle: Analysis of test solutions showed a maximum of 62.2-83.8% of nominal test substance in solution.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was weighed , and then ground into a fine powder prior to dissolving in water. The test substance was then added to a 4.5 L aspirator bottle with dilution water to bring to the volume to 4 L. The test solution was then stirred for almost 48 hrs, and then allowed to settle for 5 hrs. The test solutions were then decanted into the test chambers.

FORM AS APPLIED IN THE TEST (if different from that of starting material): solution

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All concentrations
- Sampling method: Collected from mid-depth into plastic containers.
- Sample storage conditions before analysis: Frozen if not analyzed immediately.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was weighed , and then ground into a fine powder prior to dissolving in water. The test substance was then added to a 4.5 L aspirator bottle with dilution water to bring to the volume to 4 L. The test solution was then stirred for almost 48 hrs, and then allowed to settle for 5 hrs. The test solutions were then decanted into the test chambers.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The 13-100 mg/L test solutions showed fine particulates throughout the water column immediately. By the end of the test, all test concentrations, except controls, showed white precipitate at the bottom of the containers.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Wildlife International of Easton, Maryland
- Feeding during test: yes
- Food type: yeast, cereal grass, trout chow, vitamin solutions, freshwater green alga
- Frequency: daily

ACCLIMATION
- Health during acclimation (any mortality observed): < 20%

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: 24 h old neonates were collected until each test chamber had 5 daphnids. Transfers were performed below the water surface.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

No

Hardness:

140 mg/L CaCO3

Test temperature:

19.2-20.8 °C

pH:

7.7-8.6

Dissolved oxygen:

7.8-8.8 mg/L

Conductivity:

335 µS/cm

Nominal and measured concentrations:

Nominal: 0, 6.3, 13, 25, 50, and 100 mg/L
Measured: 0, 5.42, 60.5, 68.1, 187, 88.8 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 glass beakers
- Material, size, headspace, fill volume: glass, filled to 200 mL
- Aeration: no
- 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: Wildlife International well water
- Total organic carbon: < 2 mg C/L
- Metals: < LOQ
- Pesticides: < LOQ
- Chlorine: 4.0 mg/L
- Alkalinity: 178
- Ca/mg ratio: 2.6
- Conductivity: 335 µS/cm

OTHER TEST CONDITIONS
- Photoperiod: 16 hrs light/8 hrs dark with 30 min. transition period.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilization, signs of toxicity, abnormal behavior

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: Some daphnids appeared lethargic in the 25 and 50 mg/L treatment groups. This appears to have been an effect of inhibition of movement due to precipitate. This effect did not appear to have a dose-response pattern.
- Other biological observations: The 25 mg/L group had 10% immobility, the 50 mg/L group had 25% immobility, and the 100 mg/L group had 5% immobility.
- Mortality of control: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Precipitation was noted.
- Effect concentrations exceeding solubility of substance in test medium: Yes, precipitate was noted in all test concentrations.

Reported statistics and error estimates:

Not calculated as the EL50 was above the tested concentrations.

Validity criteria fulfilled:

yes

Conclusions:

The 48-hr EL50 for the test substance is > 100 mg/L (WAF).

Executive summary:

The test substance Sucrose Palmitate Stearate MDT Grade was tested for toxicity to aquatic invertebrates. Concentrations of 0, 6.3, 13, 25, 50, and 100 mg/L were tested. The exposure lasted 48 hours. The EL50 was > 100 mg/L water accomodated fraction (WAF). The NOEL was 13 mg/L (WAF).

Description of key information

EL50 (48 h) > 100 mg/L (nominal, OECD 202)

Additional information

One experimental study is available investigating the toxicity of the test item to aquatic freshwater invertebrates. The study was performed according to OECD 202 (GLP). Daphnia magna was exposed to water accommodated fractions (WAFs) of 6.3, 13, 25, 50, and 100 mg/L and mobility was recorded every 24 h. Analytical measurement was conducted by HPLC/MS but resulted in very inconsistent results (86.1 - 465% of nominal after 0 h and < LOQ after 48 h). The analytical method focused on the free palmitic acid in test solution. Since significant hydrolysis of the substance is not expected under testing conditions a liberation of palmitic acid is not expected. Thus, the effect concentrations were based on the nominal loading rates. This procedure of evaluation of data of WAFs based on the nominal loading rates is in line with the recommendations of the OECD Guidance Document No. 23 on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2019.
After 48 h no immobilization of D. magna was observed resulting in an EL50 (48 h) > 100 mg/L based on the nominal loading rate.