oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

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:

Feb - Jun 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Test guideline 2

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:

-

EC Number:

473-690-8

EC Name:

-

Cas Number:

738602-93-2

Molecular formula:

not applicable for UVCB

IUPAC Name:

(2R,3R,4S,5S,6R)-2-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2S,3R,5R)-4-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}hexane-1,2,3,5,6-pentol

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: sponsor, Batch 4G08
- Purity, including information on contaminants, isomers, etc.: Mixture of maltotriosyl glucoside and othe roligoglucosaccharides (approx. 95 %)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature at about 20 °C, away from direct sunlight.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: assumed stable
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: assumed stable
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: analytical determination of solubility/concentrations.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): assumed stable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

For the determination of the actual test item concentrations the following samples were taken:
Just before the start of the test: duplicate samples from the test medium, duplicate samples from the control
After 48 hours: duplicate samples from the test medium, duplicate from the control

Test solutions

Vehicle:

no

Details on test solutions:

The test medium was prepared by dissolving the test item completely in 500 mL of test water using intense stirring for ten minutes at room temperature.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The study was performed with young daphnids of a clone of the species Daphnia magna Straus. A clone of this species was originally supplied by the University of Sheffield/UK in 1992. Since that time, the clone has been bred in the laboratories of RCC in reconstituted water of the quality identical to the water quality used in the tests (in respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

2.5 mmol/l

Test temperature:

20 °C

pH:

7.9

Dissolved oxygen:

8.9 mg/L

Nominal and measured concentrations:

100 mg/L nominal
The analytically determined test item concentration in the test medium at the start and the end of the test was 100 and 99 % of the nominal value.

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beaker
- Type (delete if not applicable): open (covered with glass plates)
- Material, size, headspace, fill volume: 100 mL, 50mL fill volume
- Volume of solution: 50 mL
- Aeration: the test water was aerated prior tothe start of the study until oxygen saturation was reached.
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: not applicable

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water
- Total organic carbon: not measured
- Particulate matter: not measured
- Metals: not measured
- Pesticides: not measured
- Chlorine: not measured
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1
- Conductivity: not stated
- Salinity: not applicable
- Culture medium different from test medium: no
- Intervals of water quality measurement: at start and end

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark
- Light intensity: between 570 and 750 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mobility

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

For evaluation of the quality of the Daphnia magna clone and of the experimental conditions, potassium dichromate is tested as a positive control at least once a year to demonstrate satisfactory conditions of the test

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No toxicity was observed in Daphnia when treated with the test item at the limit dose of 100 mg/L. Therefore the NOEC is > 100 mg/L.

Executive summary:

The acute toxicity of the test item MG-60 to Daphnia magna was determined in a 48 hour satic test according to the EU C.2 and OECD 202.

A limit test was performed in accordance with the EU Guideline to demonstrate that the test item has no toxic effect on the test organisms up to and including a nominal concentration of 100 mg/l. Thus, the only concentration tested was nominal 100 mg/L and control.

The analytically determined test item concentraiton in the test medium at the start and the end of the test was 100 and 99 % of thee nominal value. Under the conditions of the test, the test item MG-60 was stable during the test period of 48 hours. Therefore, all reported results are related to the nominal concentration of the test item.

In the control and at the test concentration of 100 mg/l, no immobilized test organisms were observed during the test period of 48 hours.

Therefore, the 48-hour NOEC and the 48-hour EC0 of MG-60 to Daphnia magna were determined to be at leas 100 mg/l. The 48 -hour NOEC and the 48-hour EC0 might even be higher but concentrations above 100 mg/l were not tested, according to EU Guideline. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 100 mg/L. these values could not be quantified due to the absence of toxicity of MG-60 at the test concentration of 100 mg/L.