Fatty acids, palm-oil, hydrogenated

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

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

Adequacy of study:

supporting study

Study period:

From Apr. 2010 to Sept. 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

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition 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

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Appropriate amounts of the stock solution were diluted with pure water to get TC standard solutions in the range from 1 to 50 mg Carbon/L and IC standard solutions in the range of 1 to 25 mg Carbon/L.
- Sample storage conditions before analysis: The samples from the end of the test were filtered (0.45 µm cellulose acetate) before analysis

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Inoculation of a biomass of 5000 algal cells per mL test medium
- Controls: Yes (Six replicates)
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): A supersaturated stock solution of 100 mg test item/L.

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

TEST ORGANISM
- Common name: Freshwater green algae
- Strain: Strain No. 61.81 SAG
- Source (laboratory, culture collection): Sammlung von Algenkulturen, Pflanzenphysiologisches Institut der Universität Göttingen", 37073 Göttingen, Germany
- Method of cultivation: The algae were cultivated in the laboratories under standardised conditions according to the test guidelines

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

72 h

Test conditions

Hardness:

0.24 mmol/L (= 24 mg/L) as CaCO3.

Test temperature:

23 °C

pH:

8.0 - 9.1

Nominal and measured concentrations:

Nominal: 0, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 50 mL volume with 50 mL of test medium
- No. of vessels per concentration (replicates): Six
- No. of vessels per control (replicates): Six


GROWTH MEDIUM
- Standard medium used: yes


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (OECD Medium)

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Light intensity and quality: 6120 - 6440 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Spectrophotometer

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: growth rate and yield

Effect concentrations 2

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: growth rate and yield

Effect concentrations 3

Duration:

72 h

Dose descriptor:

other: ErC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other:

Basis for effect:

growth rate

Remarks:

water accommodated fraction

Effect concentrations 4

Duration:

72 h

Dose descriptor:

other: EyC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: yield

Details on results:

- Exponential growth in the control (for algal test): Yes
- Observation of abnormalities (for algal test): No
- Unusual cell shape: No
- Colour differences: No remarkable observations
- Adherence to test vessels: No

Results with reference substance (positive control):

- Results with reference substance valid: Yes

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 72 h NOEC and LOEC of the test material was determined to be >100 mg/L (nominal). The 72 h ErC50 and EyC50 were clearly higher than the only test concentration of nominal 100 mg test item/L.

Executive summary:

A study was conducted to determine the inhibitory effect of Soybean oil, deodorizer distillates on the growth of the freshwater green algae Pseudokirchneriella subcapitata in a static test (OECD Guideline 201 and EU method C.3).

Exponentially growing cultures were exposed to water accommodated fraction of the only test concentration of nominal 100 mg/L under defined conditions. The inhibition of growth in relation to control cultures was determined over a test period of 72 h, and over several algal generations. A limit test was performed in compliance with the test guidelines to demonstrate that the test material has no toxic effect on Pseudokirchneriella subcapitata up to at least this concentration. Analytical verification of the test concentrations were conducted on samples of the freshly prepared and aged (72 h) test medium via the TOC-method.

Under the test conditions, the 72 h NOEC was determined to be >100 mg test item/L (nominal). The 72 h LOEC, E_rC₅₀ and E_yC₅₀ were clearly higher than the only test concentration of nominal 100 mg/L. These values could not be quantified due to the absence of toxicity of Oils, vegetable, deodorizer distillates up to the only test concentration of nominal 100 mg test item/L, the concentration representing the limit of solubility.