Distilled acetalization product between glucose and C12-18(even numbered)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 conduced in accordance with an adopted guideline and in compliance with the 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:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2007-01-12

Test material

Test material information

Constituent 1

Reference substance name:

Montanov S

IUPAC Name:

Montanov S

Details on test material:

Batch: T62211
Appearence: pearls of wax
Purity >99%
Stability: water 96h
solubility: water<0.1g/L
Production date: 06.06.08
Expiry date: 07.12.08
Storage: stored in a closed vessel at room temperature 20 +/- 5°C
Hazard information: not as known

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

The water-accomodated fraction was prepared by weighing the nominal load, adding the correponding 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: Umweltbundesamt Berlin
Arrival of Strain: October 4th 2005

Animal husbandry
Daphnia magna is bred in the LAUS GmbH throught the year. The animals are kept for the use in toxicity tests.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

24h and 48 hours

Test conditions

Test temperature:

18.2-19.1°C

pH:

7.4-7.8

Dissolved oxygen:

9.1-9.6 mg/L

Nominal and measured concentrations:

1 10 100 mg/L

Details on test conditions:

treatments 1 / 10 / 100 mg/L
Duration 48 hours
Observation times 24 and 48 hours
Replicates: 4 vessels, each containing 20 mL test solution and five daphnia
Control 4 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:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC100

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:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 5

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 6

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

Parameter / Value
NOEC 24h 0.625 mg/L
24h EC50 1.4 mg/L
24h Ec100 >2.5 mg/L

Validity: the 24h-EC50 of K2Cr2O7 was between 0.6 and2.1 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Duration Endpoint Effect conc. Nominal/Measured Conc. based on Basis for effect Remarks (e.g. 95% CL)
24 h NOEC ca. 100 mg/L nominal test mat. mobility
24 h EC50 > 100 mg/L nominal test mat. mobility
24 h EC100 > 100 mg/L nominal test mat. mobility
48 h NOEC ca. 100 mg/L nominal test mat. mobility
48 h EC50 > 100 mg/L nominal test mat. mobility
48 h EC100 > 100 mg/L nominal test mat. mobility

Executive summary:

Determination of 24h- and 48 h- EC50i of Montanov S against Daphnia magna Strauss according toOECD 202 resp. EU C.2

As the test item was poorly soluble, the water accomodated fraction was used, it was prepared by weighing the nominal load, adding the correponding 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 geometric series (spaced by facor 10, the highest being 100mg/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 signioficant 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 within the demanded range of 0.6 -2.1 mg/L.

The following results could be determined for the test item Montanov S (Species: Daphnia magna).

24h-NOEC= 100mg/L

48 -NOEC= 100mg/L

24h-EC50i> 100mg/L

48h-EC50i> 100mg/L