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

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:

2002-02-14 - 2002-02-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The test was performed according to relevant guidelines and compliant to GLP. It is sufficiently documented and the results are plausible.

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:

Part I - 24h EC50 acute immobilisation Test

Deviations:

yes

Remarks:

Also the EC50 after 48 hours had been determined

GLP compliance:

yes

Remarks:

according to GLP-part II 2;7

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

Name: Licowax E
ester of montan acids
active content: 100 %; light yellow solid
solubility: practically not soluble in water (ca. 100 mg/ l)

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

Treatment of the test substance
("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 °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 "Licowax E" didn't allow an investigation of higher concentrations (more than 10 g/ I).
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: Umwelt-Bundesamt, 12307 Berlin, Germany
Feeding: daily with an freshwater-alga-suspension (Scenedesmus subspicatus);
Illumination diffuse, full time;
Temperature: ca. 20 °C
Age of Daphnia for the tests: 6 - 24 hours old
Not feeding during test, performance in the dark
(20 animals per concentration)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

not applicable

Test conditions

Hardness:

Dilution water according to "ISO Test water (1)" as described in OECD guideline 202 (2004-04-13)

Test temperature:

20 +/- 1 °C

pH:

7.8

Dissolved oxygen:

89% of air saturation

Nominal and measured concentrations:

Nominal concentrations of the test item (mg/L):
11.1, 100, 1000, 10 000;

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 the basic data for evaluation the toxic effect.

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 poor solubility of the test item a limit test had been conducted

Effect concentrations 2

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 poor solubility of the test item a limit test had been conducted

Effect concentrations 3

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 poor solubility of the test item a limit test had been conducted

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 poor solubility of the test item a limit test had been conducted

Details on results:

Neither in the control, nor in the five concentration groups any immobility was observed.

Results with reference substance (positive control):

With the reference substance potassiumdichromate, a 24h EC50 of 1.0 mg/L had been determined.
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 %)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

reference substance: positive control potassiumdichromate - was fulfilled 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

Conclusions:

In an acute immobilisation test on Daphnia magna according to relevant guidelines and complient to GLP (reliability category 1), the test item did not induce any immobility in the test organisms. Accordingly, the NOEC (24 and 48 h) was determined to be 10 g/L, the EC50 (24 and 48 h) was > 10 g/L.

Executive summary:

In an acute immobilisation test on Daphnia magna according to relevant guidelines and complient to GLP (reliability category 1), the test item did not induce any immobility in the test organisms. Different concentrations were tested, the highest concentration being nominal 10 g/L, equivalent to conditions of a limit test (due to the poor solubility of the test item).

Accordingly, the NOEC (24 and 48 h) had been determined to be 10 g/L, the EC50 (24 and 48 h) > 10 g/L (nominal concentrations).