Fatty acids, tall-oil, compds. with (Z)-N-9-octadecenyl-1,3-propanediamine (2:1)

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:

The study was performed between 07 April 2009 and 09 April 2009.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Non-GLP study with no analytical monitoring.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

see "Principles of method if other than guideline"

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

yes

Remarks:

see "Principles of method if other than guideline"

Principles of method if other than guideline:

The temperature was 1-2 °C above the range required by the guidelines. As no abnormalities were observed in the controls, it was considered as non-critical.

GLP compliance:

no

Remarks:

The study was commissioned for non-REACH purposes for which GLP compliance was not a requirement.

Test material

Test material information

Constituent 1

Reference substance name:

Additiv 309

IUPAC Name:

Additiv 309

Details on test material:

Test number: 09032301 H
pH of the soln diluted in water: 7.5 (100 mg/L)

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item was stored in a sealed container at room temperature. Due to the low water solubility, the water-accommodated fractions (WAF) of the required concentrations were used. The WAF is produced by weighing of each nominal load, 24-hour shaking with the required amount of dilution water (synthetic dilution water according to ISO 6341) for testing and subsequent membrane filtration.
- Differential loading: 0, 1, 10 and 100 mg/L were tested
- Controls: potassium dichromate

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: Berlin
- Age of parental stock (mean and range, SD): For the test young animals at the age of 0-24 hours were used.
- Feeding during test
- Food type: green algae (Desmodesmus subspicatus)

Study design

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

Temperature: 20 ± 2 ° C (maximum deviation within one test ± 1 °C)

pH:

7.8 ± 0.2

Nominal and measured concentrations:

0, 1, 10 and 100 mg/L (WAF)

Details on test conditions:

TEST SYSTEM
- Test vessel: 50-mL beakers according to DIN
- No. of organisms per vessel: Use of each 5 animals in 20 mL of sample
- No. of vessels per concentration (replicates): Pre-tests were performed in duplicate, major test were conducted four times.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic dilution water prepared according to ISO 6341

OTHER TEST CONDITIONS
- Adjustment of pH: After preparation, the dilution water aerated and pH adjusted to 7.8 ± 0.2
- Photoperiod: 16/8-h light–dark rhythm

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : counting the immobilised animals after 24 and 48hours

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 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: water accommodated fraction

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

Remarks on result:

other: water accommodated fraction

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

Remarks on result:

other: water accommodated fraction

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: water accommodated fraction

Effect concentrations 5

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: water accommodated fraction

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

Remarks on result:

other: water accommodated fraction

Details on results:

As NOEC an immobilisation of max. 10% was considered (criterion for maximum immobilisation in the control).

Results with reference substance (positive control):

In a current reference test the 24hEC50i was 1.8 mg/L. Validity: the 24hEC50i of the reference substance potassium dichromate is supposed to be between 0.6 to 2.1 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

48h EC50i > 10 mg/L
NOEC 48h = 10 mg/L

Executive summary:

The test was conducted in accordance with the OECD Guideline 202 and EU Method C.2. The swimming capability or immobilisation of Daphnia Magna was used as the endpoint in determining the acute toxicity of the test item. Daphnids (< 24 hours old) were exposed to the WAF’s (0mg/L, 1 mg/L, 10mg/L and 100mg/L) over a period of 48 hours. Exposures were performed in quadruplicate in the main test (duplicates in pre-tests) using five animals in each replicate (20 mL of sample). Immobilised daphnids were recorded at 24 and 48 hours of the test. The biological results can be summarised as follows:

– 24-hour NOEC = 10 mg/L

– 24-hour EC50i = 100 mg/L

– 24-hour EC100i > 100 mg/L

48-hour NOEC = 10 mg/L

– 48-hour EC50i > 10 mg/L

– 48-hour EC100i 100 mg/L