Distilled acetalization product between glucose and C12, C14, C18, C20 ,C22 alcohol

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:

2006-12-11 to 2006-12-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been ispected by the quality unit according to the principles of Good Laboratory Practice.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

No analytical determination of the content of the test item in the test solutions during the test was made.

GLP compliance:

yes (incl. QA statement)

Remarks:

2007-01-12

Test material

Test material information

Constituent 1

Reference substance name:

Montanov L

IUPAC Name:

Montanov L

Details on test material:

Batch: T63645
Appearence: pearls of wax
Purity: ES>99%
Stability: water 96h
solubility <0.1 mg/L
Production date: 2006-09-08
Expiry date: 2008-03-09
Storage: in a closed vessel, at room temperature (20 +/- 5°C)

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

Concentrations: 1 / 10 / 100 mg/L

Test solutions

Vehicle:

no

Details on test solutions:

As the solubility lies below 100mg/L, the water-accomodated fraction was prepared for this test. This was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 um filters

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Variety: Strauss
Strain: Berlin
Sex: female
Age: between 0 and 24 hours
Origin: Umweltdundesamt Berlin
Arrival of Strain: October 4th 2005
selection of the test item was made following the proposal of the guidelines

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

18.2-19.1°C

pH:

7.4-7.8

Dissolved oxygen:

above 9.1 mg/L

Nominal and measured concentrations:

1 / 10 / 100 mg/L

Details on test conditions:

Main study
Selection of Daphnia
24 hours before the start of the test, the adult animal were separated from the young. 23 hours later, the newborn daphni, aged between 0 and 23 hours, were sieved from the medium and immediatly placed into a 250 mL beaker containing dilution water. After a settling-in period of 30 minutes, animals which showed no apparent damage were used for the test.

Study performance
Using a glass tube (diameter approx. 8 mm), the daphnia were caught anf lifted from the beaker. They were put on a small sieve, and the medium surrounding the animals was sucked off using absorbent paper. Immediatly after that, the animals were put into the respective solution.
The test vessels were left to stand for 48 hours. After 24 and 48 hours, the immobilised daphnia were counted. Daphnia are considered immobilised if they perform no movements or are only able to move their antennae when the beaker is gently agitated.
The pH concentration of dissolved oxygen in the test vessels were measured at the beginning and at the end of the test.

Experimental condition: Vessels: glass beakers, nominal volume 50 mL, tall shape
Feedong: none
Lighting: none
Temperature: 20 +/- 2°C

Date of performance: December 12th-14th 2006
Treatments: 1 / 10 / 100 mg/L
duration: 48 hours
Observation time: 24 and 48 hours
Replicate: four vessels, each containing 20 mL test solution and five daphnia
control: four vessels, each containing 20 mL dilution water and five daphnia

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

ca. 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.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

24h-EC50 of K2Cr2O7 was determined at 1.4 mg/L, lying with the demanded range og 0.6 -2.1 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

24 h NOEC ca. 100 mg/L
48 h NOEC ca. 100 mg/L
24 h EC50 >= 100 mg/L
48 h EC50 >= 100 mg/L

Executive summary:

Determination of 24h-and 48h EC50i of Montanov L against Daphnia magna Strauss according to OECD 202 resp EU C.3.

This study was performed in order to evaluate the toxic potential of Montanov L towards freshwater, using the species Daphnia magna. Daphnia magna STRAUSS, which belongs to the family of crustacea, was chosen in the guideline as a typical part of zoo-plancton. The study was performed for notification purposes.

The study was conduced in accordance to the following guideline:

OECD guideline for testing of chemicals n°202: Daphnia sp., Acute immobilisation test

EU guideline C.2 Acute toxicity for Daphnia

As the item is poorly soluble, the water accomodated fraction was used for the test. This was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 um filters.

In the main study, three concentrations of the test item in a grometric series (spaced by factor 10, the highest being 100 mg/L) were used. Twenty daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.

No immobilisation was observed in the treatments and in the control. The 24h-EC50i of potassium dichromate was tested in a current reference test. The value was determined as 1.4 mg/L, lying with the demanded range og 0.6 -2.1 mg/L.

the following results could be determined for the test item Montanov L (species Daphnia magna).

24 h NOEC ca. 100 mg/L

48 h NOEC ca. 100 mg/L

24 h EC50 >= 100 mg/L

48 h EC50 >= 100 mg/L