Soybean oil, reaction products with ethaneperoxoic acid

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February to March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted to a recognised OECD protocol with no significant deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, reaction products with ethaneperoxoic acid

Cas Number:

693217-63-9

Molecular formula:

C59 H106 O11

IUPAC Name:

Soybean oil, reaction products with ethaneperoxoic acid

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): AGROL® POLYOL 693217-63-9

- Substance type: UVCB
- Physical state: Liquid
- Analytical purity: Acid value: 0.5 mg KOH/g; Hydroxyl value: 111 mg KOH/g

- Purity test date: 8 February 2013
- Lot/batch No.: 13-3.6-ASO-004
- Expiration date of the lot/batch: Given as 360 days from the date of analysis.

- Stability under test conditions: Stable.
- Storage condition of test material: Room temperature.

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: N/A
- Source: STILLMEADOW, Inc. culture laboratory
- Age at study initiation (mean and range, SD): No greater than 24 hours old at dosing
- Weight at study initiation (mean and range, SD): N/A
- Length at study initiation (length definition, mean, range and SD): N/A
- Valve height at study initiation, for shell deposition study (mean and range, SD): N/A
- Peripheral shell growth removed prior to test initiation: N/A
- Method of breeding: N/A
- Feeding during test Organisms were not fed during the test.
- Food type: Organisms were not fed furing the test.
- Amount: N/A
- Frequency: N/A

ACCLIMATION
- Acclimation period: Not stated.
- Acclimation conditions (same as test or not): Daphnids were held in water of the same quality used in the test.
- Type and amount of food: N/A
- Feeding frequency: N/A
- Health during acclimation (any mortality observed): Not given.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

24 h

Post exposure observation period:

N/A

Test conditions

Hardness:

Range-finding: total hardness of 225 mg/L CaCO3
Limit: total hardness of 260 mg/L CaCO3

Test temperature:

Temperature Range of 20 ± 2°C.
Actual Temperature: 21-22°C.

pH:

Range-finding: pH of 7.0
Limit: pH of 7.8

Dissolved oxygen:

Dissolved oxygen concentration of 60-105% saturation at dosing.

Salinity:

N/A

Nominal and measured concentrations:

All test concentrations were expressed as nominal values.
Range finding test: 0.1, 1.0, 10, 50, 100 mg/L.
Limit test: 100 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL glass beakers

- Aeration: N/A
- Type of flow-through (e.g. peristaltic or proportional diluter): N/A
- Renewal rate of test solution (frequency/flow rate): N/A
- No. of organisms per vessel: Range finder: 10 per test concentration. Limit: 30 per test concentration.
- No. of vessels per concentration (replicates): Limit test: three replicates.
- No. of vessels per control (replicates): Limit test: three replicates.
- No. of vessels per vehicle control (replicates): N/A
- Biomass loading rate: N/A

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic fresh water.
- Total organic carbon: N/A
- Particulate matter: N/A
- Metals: N/A
- Pesticides: N/A
- Chlorine: N/A
- Alkalinity: N/A
- Ca/mg ratio: N/A
- Conductivity: Control: 0 hour: 694 µmhos/cm; 48 hours: 792 µmhos/cm. 100 mg/L: 0 hour 693 µmhos/cm; 48 hours 731 µmhos/cm
- Culture medium different from test medium: N/A
- Intervals of water quality measurement: At dosing and termination of the Limit test.

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16-hours light / 8-hours dark cycle
- Light intensity: N/A

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Temperature
Control 0 hours 21°C, 48 hours 21°C; 100 mg/L 0 hours: 21°C; 48 hours 21°C.
pH
Control 0 hours 7.8; 48 hours 7.7. 100 mg/L 0 hours 7.7, 48 hours 7.8.
Dissolved Oxygen
Control 0 hours 93%, 48 hours 84%; 100 mg/L 0 hours 90%, 48 hours 83%

TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A
- Justification for using less concentrations than requested by guideline: N/A
- Range finding study
- Test concentrations: 0.1, 1.0, 10, 50, 100 mg/L.
- Results used to determine the conditions for the definitive study: 100 mg/L

Reference substance (positive control):

no

Remarks:

N/A

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: N/A
- Observations on body length and weight: N/A
- Other biological observations: N/A
- Mortality of control: N/A
- Other adverse effects control: N/A
- Abnormal responses: N/A
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: N/A
- Effect concentrations exceeding solubility of substance in test medium: N/A

Results with reference substance (positive control):

- Results with reference substance valid? N/A
- Mortality: N/A
- EC50/LC50: N/A
- Other: N/A

Reported statistics and error estimates:

The test was considered valid if the control immobility did not exceed 10%. The control was used to compare the immobility endpoints of the test concentrations. The NOEC (No Observed Effect Concentration) and EC50 (Median Effective Concentration) were determined by a commercially available statistical program (ToxCalc Version 5.0™). Several models are available for EC50 determination: Probit, Trimmed Spearman-Karber, and Linear Interpolation. The most appropriate model was selected for the determination in this case.

Any other information on results incl. tables

Limit Test

Concentrationmg/L	Replicate	Number of Mobile Organisms			Mobility
		0 Hours	24 Hours	48 Hours
0	A	10	10	10	100%
	B	10	10	10
	C	10	10	10
100	A	10	10	10	100%
	B	10	10	10
	C	10	10	10

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

This study was conducted to assess the toxicity of the test substance, AGROL® POLYOL, to the freshwater invertebrate Daphnia magna in a 48-hour static test. The EC50 (median effective concentration) was determined to be greater than 100 mg/L AI and the NOEC (No Observed Effect Concentration) was determined to be 100 mg/L AI. Results presented are based on nominal concentrations.

Executive summary:

This study was conducted to assess the toxicity of the test substance, AGROL® POLYOL, to the freshwater invertebrate Daphnia magna in a 48-hour static test. The range-finder indicated an EC50 of greater than 100 mg/L; therefore, a limit test was conducted in lieu of a definitive. The limit test was conducted using the test substance, as received, at 100 mg/L that was administered to the test system, Daphnia magna, in moderately hard synthetic freshwater. For the limit test, three replicates of ten organisms each were treated at the test concentration. A control group containing three replicates of ten organisms each was not exposed to the test substance. Dissolved oxygen, temperature, conductivity and pH measurements were recorded at dosing, and at 48 hours after dosing. Observations for immobility in each test chamber were made daily. The test was terminated after 48 ± 1 hours of exposure. The EC50 (median effective concentration) was determined to be greater than 100 mg/L and the NOEC (No Observed Effect Concentration) was determined to be 100 mg/L for both limit tests. Results presented are based on nominal concentrations.