Soybean oil, deodorizer distillate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From Mar. 24, 2010 to Apr. 17, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to standard guidelines in compliance with GLP.

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:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

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 distillates'

IUPAC Name:

'Soybean oil, deodorizer distillates'

Constituent 2

Reference substance name:

Soybean oil, deodorizer distillate

EC Number:

272-211-8

EC Name:

Soybean oil, deodorizer distillate

Cas Number:

68783-88-0

Molecular formula:

No generic molecular formula is available

IUPAC Name:

Not available for UVCB

Details on test material:

- Name of test material (as cited in study report): 'Soybean oil, deodorizer distillates' (CAS N°68783-88-0, EINECS N° 272-211-8)
- Substance type: Fatty acids and unsaponifiable matter of vegetable origin
- Physical state: Liquid pasty, brown
- Storage condition of test material: In original container, at room temperature (15 - 25°C), in the dark
- Purity test date: October 27, 2009
- Expiration date of the lot/batch: April 27, 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.

Analysis of the Test Item Concentrations:
- Sampling: Duplicate samples from the freshly prepared test medium of the only test concentrations and the control were taken at the start of the test. For the determination of the stability of the test material under the test conditions, respectively the maintenance of the test item concentrations during the test period, samples were taken in duplicate out of all test media and the control at the end of the test (96 h).
- Analysis: The concentrations of the test item were analysed in the duplicate test media samples from the only test concentration and both sampling times (0 and 96 h). From the control samples only one of the duplicate samples was analysed from each of both sampling times.

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
1,000 mg of the test item were added directly to 10,000 mL test water and carefully stirred for about 24 hours at room temperature in the dark to dissolve as much as possible. After cessation of mixing and a following period of settling to allow phase separation, the aqueous phase, i.e. the water accommodated fraction, was drawn off carefully and used as the test medium.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow Trout
- Source: Forellenzuchtbetrieb Fraunhofer Institut Molekularbiologie und Angewandte Oekologie, Auf dem Aberg 1, 57392 Schmallenberg, Germany.
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD): 4.83 ± 0.36 cm
- Weight at study initiation (mean and range, SD): 0.90 ± 0.25 g
- Method of breeding:
- Feeding during test: No


ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): Same
- Feeding frequency: Three times/wk or daily until 24 h before the test was started
- Health during acclimation (any mortality observed): No

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

None

Test conditions

Hardness:

2.5 mmol/L (= 250 mg/L) as CaCO3

Test temperature:

14 - 15 °C

pH:

7.9- to 8.1

Dissolved oxygen:

91- 100% of the air saturation value

Salinity:

No data

Nominal and measured concentrations:

Nominal: 0, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 12 L glass aquaria with 8 L test medium
- Aeration: Yes (slightly aerated during the test)
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1 (based on molarity)
- Conductivity: < 10 µScm-1
- Culture medium different from test medium: No


OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16 h light : 8 h dark; 30 min dawn/dusk period
- Light intensity: 590 - 1160 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The test fish were observed after approximately 2, 24, 48, 72 and 96 h test duration for sublethal effects and mortality.

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):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: mortality and sublethal effects

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: mortality and sublethal effects

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: mortality and sublethal effects

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: mortality and sublethal effects

Effect concentrations 5

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fraction

Basis for effect:

other: mortality and sublethal effects

Details on results:

- Behavioural abnormalities: No
- Mortality of control: No
- Other adverse effects control: No sublethal effects during the exposure time
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: There were no remarkable observations

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

No data

Any other information on results incl. tables

Sublethal observations / clinical signs:

Determination of the Test Item	Based on the results of TOC measurements the concentration of the test item was determined using a calibration curve.
Calibration Range	1 to 50 mg Carbon/L in pure water in the case of TC-calibration and 1 to 25 mg Carbon/L in pure water in the case of IC-calibration
Linearity of Response	Correlation of peak area of different standard solutions with their corresponding concentrations, using a linear regression
Regression Coefficient	At least 0.9987 in the case of TC at least 0.9955 in the case of IC
Typical Calibration Curve	y =4.1577 * x - 1.0347in the case of TC y =3.5631 * x – 1.1193in the case of IC
Limit of Detection	LODTC:2.252mg Carbon/L;  LODIC:1.911 mg Carbon/L
Limit of Quantification	5 mg Carbon/L 119 % (n = 4, RSD 9 %)
Mean Recovery in the Fortified Samples	111 % (n = 4, RSD 2 %)
Mean recovery in the test samples	Since the test item is not well water soluble, all results were below LOQ

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 96 h LC50 of the test substancewas > 100 mg/L (nominal). The96 h NOECwas 100 mg/L (nominal).

Executive summary:

A study was conducted to evaluate the acute toxicity of 'soybean oil, deodorizer distillates' to freshwater rainbow trout (Oncorhynchus mykiss) in a static test (OECD Guideline 203 and EU method C.1).

Rainbow trout were exposed to water accommodated fraction of the nominal test concentrations of 0 and 100 mg/L for 96 h. Mortality and signs of toxicity were followed throughout the study. 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 96 h were analysed via the TOC-method.

Under the test conditions, the 96 h LC50 of the test substancewas > 100 mg/L (nominal). The96 h NOECwas 100 mg/L (nominal).