Fatty acids, palm-oil, hydrogenated

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

From Mar. 2010 to Oct. 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to standard guidelines in compliance with GLP. TOC analyses conducted as dose verification.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 3

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, 2000

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, deodorizer distillate

EC Number:

272-211-8

EC Name:

Soybean oil, deodorizer distillate

Cas Number:

68783-88-0

IUPAC Name:

68783-88-0

Constituent 2

Reference substance name:

Soybean oil, deodorizer distillates

IUPAC Name:

Soybean oil, deodorizer distillates

Details on test material:

- Name of test material (as cited in study report): Soybean oil, deodorizer distillates
- Substance type: Glycerides, fatty acids and unsaponifiable matter of vegetable origin
- Physical state: Liquid/pasty, brown
- Storage condition of test material: At room temperature (15 - 25 °C), in the dark
- Expiration date of the lot/batch: 27 April 2010

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
- Sampling method: The concentrations of the test substance were analysed in the duplicate test media samples from both sampling times (0 and 48 hours). From the control samples only one of the duplicate samples was analysed from each of both sampling times.
- Sample storage conditions before analysis: All samples were stored in a freezer (≤ - 10 °C), protected from light until analysis was performed

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
200.8 mg of test item were added directly to 2008 ml of test water and carefully stirred for about 24 hours at room temperature in the dark to dissolve as much of the test item as possible. After cessation of stirring and a following period of settling to allow phase separation, the aqueous phase, i.e. the water accomodated fraction, was drawn off carefully and used as the test medium.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Clone 5
- Source: In house laboratory culture (i.e. IBACON testing laboratory)
- Age at study initiation (mean and range, SD): 6.25 to 21.5 h old
- Method of breeding: The cultivation of the parental Daphnia was performed in reconstituted water of a similar quality with regards to pH, the constituent salts and total hardness as the test water used in the test. The test organisms were not first brood progeny
- Food type: Green algae (Desmodesmus subspicatus) freshly grown in the lab
-Frequency: Daily

ACCLIMATION
- Was not necessary, since the test was performed in the same medium as the culturing

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg/L as CaCO3

Test temperature:

21 °C

pH:

7.7- 7.8

Dissolved oxygen:

8.1 - 8.8 mg/L

Salinity:

No data

Nominal and measured concentrations:

Nominal: 0 and 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers
- Type (delete if not applicable): Closed with lids
- Material, size, headspace, fill volume: Glass beakers of 100 mL volume containing approximately 60 mL of test medium.
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 20 Daphnia per control and test concentration, divided into 4 groups of 5 animals, each group in 50 mL test medium



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt "M4" reconstituted water
- Alkalinity: 0.9 mmol/L
- Culture medium different from test medium: No


OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16 h light: 8 h dark
- Light intensity: 940 - 1150 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility of the Daphnia was determined by visual observation after 24 and 48 h. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile (even if they could still move their antennae).


TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: Yes
Since a dose-related effect of the test material was observed in an additional range-finding test for the water accommodated fractions of nominal 10 and 1.0 mg/L. Nominal test concentrations 10, 4.6, 2.1, 0.95 and 0.43 mg/L were tested in the main experiment.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accomodated fraction

Basis for effect:

mobility

Remarks on result:

other: -

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accomodated fraction

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: No
- Mortality of control: No
- Other adverse effects control: None

Reported statistics and error estimates:

None

Any other information on results incl. tables

The concentration of test substance recorded by total organic carbon analysis was below the limit of quantification in the control and test vessels. The LOQ was equivalent to 3 mg/L. Test concentrations were therefore based on nominal values.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 48 h EC50 of the test substance was > 100 mg/L (nominal). The 48 h NOEC was 100 mg/L (nominal).

Executive summary:

A study was conducted to determine the acute toxicity of Soybean oil, deodorizer distillates to Daphnia magna in a static 48 h immobilisation test (OECD Guideline 202 and EU method C.2).

Daphnia magna (20 per dose) were exposed to water accommodated fraction of the nominal test concentrations of 0 and 100 mg/L for 48 h. Immobility of theDaphnia was determined by visual observation after 24 and 48 h. Analytical verification of the test concentrations were conducted at the concentrations of the test material in the test medium. The samples collected at start and after 48 h were analysed via the TOC-method.

Under the test conditions, the 48 h EC50 of the test substance was > 100 mg/L (nominal). The 48 h NOEC was 100 mg/L (nominal).