Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, calcium salts and Montan wax

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 14 FEB to 22 FEB 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to relevant guideline and compliant to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Vers. APR 1984, Part I, 24h acute immobilization test

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Montan waxes, type WE 4

IUPAC Name:

Montan waxes, type WE 4

Constituent 2

Reference substance name:

Reaction mass of Fatty acids, montan-wax and Glycerides, montan-wax and Montan wax

EC Number:

914-469-2

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of Fatty acids, montan-wax and Glycerides, montan-wax and Montan wax

Details on test material:

"Licolub WE 4" ester of montanacids
active content: 100 %

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

According to "Guidance Document On Aquatic Toxicity Testing Of Difficult Substances And Mixtures" of the OECD, Environmental Health and Safety Publications, No. 23 - 3.1 Poorly water-soluble substances.

A definite amount of the test substance (10 mg; 100 mg; 10 g etc.) was filled into measuring flask and the total volume made up with water at 21 +/- 1 deg C.
The solution was shaken during 24 hours. The test substance was not soluble in water.
Shaking produced a dispersion of the test substance. Then the solution was filtrated. The hydrophobic properties of "Licolub WE 4" didn't allow an investigation of higher concentrations (more than 10 g/L).
The test bottles were conditioned about 15 minutes before the test was started.
The pH value and oxygen concentration were measured at the beginning and the end of the test.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna STRAUS
Supplier: Umweltbundesamt, 12307 Berlin
Feeding: daily with an freshwater-alga-suspension (Scenedesmus subspicatus); illumination diffuse, full time Temperature: ca. 20 deg C
Age of Daphnia for the tests: 6 - 24 hours old
Not feeding during test, performance in the dark (20 animals per concentration)

Dilution water: produced synthetically, pH value 7.8; ISO-Test water: 25 mL/L each of solutions (CaCl2 * 2 H20, MgSO4 * 7H20, NaHCO3 and KCI)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

ISO Test water as recommended by the guideline

Test temperature:

20 +/- 1 deg C

pH:

Control
test start: 7.8; test stop: 7.4

treatment groups:
test start: 7.3 - 7.6
test stop: 7.1-7.7

Dissolved oxygen:

[mg/L]
Control:
test start: 6.5; test stop: 5.8;

treatment groups:
test start: 6.2-6.5;
test stop: 5.3 - 5.5;

Nominal and measured concentrations:

Applied nominal concentrations: 11.8, 100, 1000 and 10000 mg/L
The test item was insoluble. No analytical determination;

Details on test conditions:

The investigation of acute immobilization was performed as described in the OECD 202 method. The species Daphnia magna STRAUS were put into the test solution of chosen concentrations.
20 Daphnia were used for each test concentration in a test volume of 40 mL (four groups of five animals each). The animals were inspected after 24 and 48 hours. The inhibitory effect on the swimming capability of Daphnia was observed.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

10 g/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Due to the poor solubility of the submission substance test solutions were prepared with nominal concentrations and filtered before application.

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 g/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Due to the poor solubility of the submission substance test solutions were prepared with nominal concentrations and filtered before application.

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 10 g/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Due to the poor solubility of the submission substance test solutions were prepared with nominal concentrations and filtered before application.

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 10 g/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Due to the poor solubility of the submission substance test solutions were prepared with nominal concentrations and filtered before application.

Details on results:

Neither in the control nor in the treatment groups any immobilizations were observed.

Results with reference substance (positive control):

Potassium dichromate:
24h-EC50 = 1.0 mg/L
mortality of the Daphnia in the control solution at the end of the test: 0 % (reference value < 10 %)
dissolved oxygen concentration 89 % of the air saturation (reference value > 60 %)

Reported statistics and error estimates:

A Probit analysis was not possible as no effect was observed.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In an acute toxicity test with the submission substance on Daphnia magna according to OECD 202 no immobilization was observed neither in the treatment groups up to 10 g/L nominal concentration nor in the control.
NOEC (24 and 48 h) = 10 g/L
EC50 (24 and 48 h) > 10 g/L

Executive summary:

In an acute toxicity test with the submission substance on Daphnia magna according to OECD 202 and compliant to GLP (reliability category 1) no immobilization was observed neither in the treatment groups up to 10 g/L nominal concentration nor in the control.

NOEC (24 and 48 h) = 10 g/L

EC50 (24 and 48 h) > 10 g/L