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Diss Factsheets

Ecotoxicological information

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:
26 Apr-15 Jul 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (test concentrations could not be maintained throughout the test)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
equivalent or similar to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECDGuideline 23 (Guidance document on aquatic toxicity testing of difficult substances and mixtures)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl myristate
EC Number:
204-680-1
EC Name:
Methyl myristate
Cas Number:
124-10-7
Molecular formula:
C15H30O2
IUPAC Name:
methyl myristate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Fettsäuremethylester-C14
- Physical state: clear colourless liquid
- Analytical purity: > 99%
- Lot/batch No.: S5327813912
- Expiration date of the lot/batch: 23 February 2011
- Storage condition of test material: at room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from all test concentrations and the control.
- Sampling method: Singular samples (3 mL from the approximate centre of the test vessel) for possible analysis were taken at the start of the test, after 24 hours from the freshly prepared solutions and at the first renewal, and at the end of the test from the 24-hour old solutions. At the end of each refreshment period, the replicates were pooled at each concentration before sampling. Additionally, reserve samples of 3 mL were taken for possible analysis.
- Sample storage conditions before analysis: The samples were stored in the freezer until analysis.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with aqueous mixtures at a loading rate of 100 mg/L. The mixtures were magnetically stirred for 23 to 24 hours. The mixtures were left to settle for 2 hours to achieve a good phase separation. The Water Soluble Fraction (WSF) was collected from mid solution by siphoning and additionally filtered through a glass fibre filter. The lower test concentrations were prepared by subsequent dilutions in test medium.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Straus
- Source: In-house laboratory culture
- Age at study initiation: < 24 h
- Method of breeding: start of each batch with newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
At the start: 21 °C
During the test: 20.6 - 21.2 °C
pH:
Control and all concentrations from start till the end of the test: 7.9 - 8.1
Dissolved oxygen:
7.9-9.0 mgO2/L
Nominal and measured concentrations:
Nominal: control, 10, 18, 32, 56 and 100% of the WSF prepared at a loading rate of 100 mg/L
Measured: before test medium renewal, concentrations were below the limit of detection. At t=24 h (after renewal) a concentration of 0.0198 mg/L was determined at 100% WSF. At test termination, concentrations were again below the limit of detection
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 60 mL, all-glass, containing 50 mL test solution
- Renewal rate of test solution (frequency/flow rate): after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: adjusted ISO medium
- Intervals of water quality measurement: pH and dissolved oxygen at the beginning, after 24 h of exposure and at the end of the test for all concentrations and the control; temperature of medium was measured continously in a temperature control vessel, beginning at the start of the test

OTHER TEST CONDITIONS
- Photoperiod: 16 hours daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobility including mortality at 24 and 48 hours

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: Control and the WSF prepared at a loading rate of 100 mg/L and 0.10, 1.0 and 10% of the WSF.
- Results used to determine the conditions for the definitive study: 55% immobile daphnids were observed after 48 exposed to the undiluted WSF (100 mg/L nominal). No immobility was observed at any of the dilutions. The expected EC50 was between 10 and 100% of the WSF or between initial measured concentrations of 2.1 and 0.21 mg/L. Measured concentration decrease during the 48-hour test period to a value below the Limit Of Detection (LOD). Based on these results it was decided to continue with testing a range of WSF dilutions between 10 and 100% with a spacing factor of 1.8 and to renew test solutions after 24 hours.
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
other: filtered test solution
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: filtered test solution
Basis for effect:
mobility
Details on results:
- No significant immobility was observed at any of the concentrations tested (5-10%). No floating layer at the surface of the test solutions was observed
- No immobilisation was reported in the control replicates
Results with reference substance (positive control):
- Results with reference substance valid? Yes, 48h-EC50 was between 0.3 and 1.0 mg/L
- EC50/LC50: EC50 (48h) = 0.36 mg/L (95% confidence interval 0.28 - 0.49 mg/L)

Any other information on results incl. tables

Due to the very low solubility of the test substance in water, concentrations tend to drop after 24 hours below the LOD of the analytical method. Therefore, a semi-static test regime was chosen, in which no harmful effects on test organisms could be observed. No floating layer was observed.

Table 1: Immobility of daphnids after 24 and 48 hours

Test substance

% of WSF prep. at 100 mg/L

Vessel number

Number Daphnia exposed

Response at 24h

Response at 48 h

Number

Total %

Number

Total %

Control

A

B

C

D

5

5

5

5

0

0

0

0

0

0

0

0

0

0

10

A

B

C

D

5

5

5

5

0

1

0

0

5

0

1

1

0

10

18

A

B

C

D

5

5

5

5

0

1

0

0

5

0

1

1

0

10

32

A

B

C

D

5

5

5

5

0

0

0

0

0

1

1

0

0

10

56

A

B

C

D

5

5

5

5

0

0

1

0

5

0

0

1

0

5

100

A

B

C

D

5

5

5

5

0

1

0

0

5

0

1

0

0

5

 

 

Table 2: Concentrations of the test medium

(LOD = Limit of detection (0.013 mg/L); * = Obtained by extrapolation of the calibration curve, indicative result)

Time of sampling [hours]

Date of sampling [dd-mm-yy]

Date of analysis [dd-mm-yy]

Percentage of WSF [%]

Analysed concentration [mg/L]

0

(fresh)

13-07-10

16-07-10

0

100

< LOD

< LOD

24

(old)

14-07-10

16-07-10

0

100

< LOD

< LOD

24

(fresh)

14-07-10

16-07-10

0

100

< LOD

0.0198*

48

(old)

15-07-10

16-07-10

0

100

< LOD

< LOD

 

Applicant's summary and conclusion