oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

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.1 (Acute Toxicity for Fish)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity 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:

liquid

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.: 54.2 % Maltotriosyl glucoside


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature at about 20 °C away from direct sunlight

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

duplicate samples were taken from freshly prepared test medium, after 48h and after 96 hours..

Test solutions

Vehicle:

no

Details on test solutions:

test medium was freshly prepared by completely dissolving test item in test water using stirring for 15 minuetes at room temperature

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra Fish
- Strain:
- Source: Zoo Schraub, CH-4410 Liestal, Switzerland
- Age at study initiation (mean and range, SD): not stated
- Length at study initiation (length definition, mean, range and SD): 3.1 +- 0.2 cm
- Weight at study initiation (mean and range, SD): 0.22 +- 0.04 g

ACCLIMATION
- Acclimation period: at least two weeks

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

216 mg/L CaCo3

Test temperature:

21-22 °C

pH:

between 8.0 and 8.6

Dissolved oxygen:

between 8.3 and 8.8 mg/L

Nominal and measured concentrations:

100 mg/L nominal,
ca. 107 mg/L measured

Details on test conditions:

glass aquarium with 5 L,
light conditions 16 hour light to 8 hour dark, with 30-minute transition period

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

no mortality observed, no abnormal fish observed

Results with reference substance (positive control):

not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

the test item has no toxic effect on the test fish at a nominal concentration of 100 mg/L

Executive summary:

The acute toxicity of the test item MG-60 to zebra fish (Brachydanio rerio) was determined in a 96 hour static test according to the EUCommission Directive 92/69/EEC, Part C.1 (1992), and the OECD Guideline for Testing of Chemicals No. 203, (1992).

A limit test was perforemd in accordance with the guidelines. During the test period the analytically measured test item concentration in the analyzed test medium was in the range from 103 to 109 % of the nominal value. Under the conditions of the test the test item MG-60 was stable during the test period of 96 hours.

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 mortalty or other visible abnormaliteis were determined at the test fish during the test period of 96 hours.

Therefore the 96 horus NOEC, and the 96 hour LC0 might even be higher than this concentraiton, but concentrations in excess of 100 mg/L have not been tested, according to the guidlines. The 96-hour LOEC, the 96-hour LC50 and the 96-hour LC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of MG-60 at the tested concentration.