Reaction product of Saccharose, Glycerine, biodiesel propoxylated

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study without restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of saccharose, glycerine, biodiesel, propoxylated

IUPAC Name:

Reaction product of saccharose, glycerine, biodiesel, propoxylated

Details on test material:

- Name of test material (as cited in study report): Reaction product of saccharose, glycerine, biodiesel, propoxylated
- Physical state: liquid
- Analytical purity: not applicable, UVBC substance with unkown or variable composition
- Expiration date of the lot/batch: 2014-06-15

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sample storage conditions before analysis: the samples were stabilised (dilution factor 2) to 10 mg/L with acetonitrile : daphnia dilution water (Elendt M4) (50 : 50) containing 0.1% formic acid. This solution was further diluted with acetonitrile : daphnia dilution water (Elendt M4) (50 : 50) containing 0.1% formic acid and used for calibration (6 concentrations).

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accomodated fraction approach according to OECD GD 23 and ECETOC No. 26, 1996 was performed. A nominal loading of 100 mg/L was mixed with an appropriate ammount of dilution water and shaken for 24 hours at room temperature. After 24 hours, undissolved particles were removed by filtering (membrane filter 0.45 µm). The resulting water soluble fraction was used in the test without further pretreatment.
- Concentration of vehicle in test medium (stock solution and final test solution): 100 mg/L loading rate
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu, now part of the German Federal Envrionmental Agency - Umweltbundesamt, UBA)
- Age at study initiation (mean and range, SD): 2- 24 hours
- Method of breeding: in glass vessels (2-3 L) with approx. 1.8 L culture medium at 20 +/- 2°C in an incubator, light-dark 16:8 hours.
- Feeding during test: none

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

pH:

7.39-7.52

Dissolved oxygen:

5.32-8.64 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers, 50 mL volume, loosely covered with a watch glass
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, test volume 20 mL
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): renewal every 24 hours
- 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: same as culture medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 light:dark
- Light intensity: max. 20 µE x m2 x s-1

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none
- Justification for using less concentrations than requested by guideline: non-GLP pre-test revealed no effects up to 100 mg/L
- Range finding study: yes
- Test concentrations: 100 mg/L loading rate
- Results used to determine the conditions for the definitive study: same as in the study itself

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities:
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes, therefore loading rate and water accomodated fraction was applied

Results with reference substance (positive control):

- Results with reference substance valid?
- Mortality: yes
- EC50/LC50: 1.74 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes