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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Oct - 25 Oct 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019
Reference Type:
other: Analytical report
Title:
Unnamed
Year:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)
Remarks:
Groupe interministeriel des produits chimiques (15 Nov 2018)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecanoic acid, ester with 1,2-propanediol
EC Number:
253-462-2
EC Name:
Dodecanoic acid, ester with 1,2-propanediol
Cas Number:
37321-62-3
Molecular formula:
C15H30O3 C27H52O4
IUPAC Name:
Dodecanoic acid, ester with 1,2-propanediol

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.95; 1.53; 2.44; 3.91; 6.25 and 10 mg/L
- Sampling method: Lauroglycol monoester and Lauroglycol diester was measured at 0 and 48 hours. Diester: 2 mL of sample were pipetted into a 15 mL conical bottom glass tube and 2 mL of ethyl acetate were added. Samples were vortexed and layers were allowed to separate for one minute. 1 mL of the upper layer was pipetted into a GCMS vial. Monoester: 2 mL of sample were pipetted into a 15 mL conical bottom glass tube and 2 mL of hexane were added. Samples were vortexed and centrifuged for 2 min at 1500 rpm. 1 mL of the upper layer was pipetted into a GCMS vial and 50 μL of derivative agent BSTFA + 1 % TMCS were added.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solutions were prepared by water accommodated fractions (WAF) approach according to OECD monograph No. 23. WAFs were prepared individually. Measured quantities of test item were added directly to test medium and mixed for 18 hours to achieve an equilibrated concentration of dissolved and dispersed or emulsified components in the aqueous phase. The test solutions have not been filtered. The test solutions used were therefore emulsions of the test element.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: waterflea (bred at testing facility)
- Strain/clone: clone 5
- Age of parental stock (mean and range, SD): 6 - 24 hours

CULTURE CONDITIONS:
- Medium: Elendt M4
- Temperature: 20 °C ± 2
- Light/dark cycle: 16 h/8 h
- pH: Between 6 and 9
- Type and amount of food: Pseudokirchneriella subcapitata and Chlorella vulgaris suspensions
- Feeding frequency: daily

Study design

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

Test conditions

Test temperature:
20.6 - 20.8 °C
pH:
7.9 - 8.0
Dissolved oxygen:
8.0 - 9.1 mg/L
Nominal and measured concentrations:
nominal (loading rates): 0.95; 1.53; 2.44; 3.91; 6.25 and 10 mg/L
measured: see below table 2 under "Any other information on results
Details on test conditions:
TEST SYSTEM
- Test vessel: glass flasks
- Fill volume: 100 mL size with 50 mL of test solution
- 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: OECD medium in accordance with OECD 202
- Intervals of water quality measurement: pH, dissolved oxygen and temperature were recorded at the beginning and the end of the test.

OTHER TEST CONDITIONS
- Photoperiod: dark/ light cycle 16/ 8 hours
- Light intensity: 300 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): After 24 and 48 hours, the number of immobile daphnids in each replicates was recorded.

RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: 100% immobilised daphnids were observed for 10 and 100 mg/L. No immobilisation was dertermined for 1 mg/L.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
6.59 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
95% CL: 6.33 - 6.85 mg/L
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: EC50 (24h) = 1.851 (95% CL 1.753 – 1.948)
Reported statistics and error estimates:
The probits method is used for the estimation of the effect concentration.

Any other information on results incl. tables

Table 1: Validity criteria for OECD 202.

Criterion from the guideline

Outcome

Validity criterion fulfilled

In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.

0% immobility was recorded after 48 hours exposure

yes

The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.

The dissolved oxygen concentration in the lowest concentration producing the maximum effect at the end of the test was 8.0 mg/L

yes

 

 

Table 2: Immobilized daphnids 48 hours after exposure

 

ID

Target concentration

[mg test item.L-1]

Immobilized daphnids 48 hours after exposure

Total of immobilized daphnids

Mean of immobilized daphnids (%)

Replicates

A

B

C

D

C05

0

0

0

0

0

0

0

C06

0.95

0

0

0

0

0

0

C07

1.53

0

0

0

0

0

0

C08

2.44

0

0

0

0

0

0

C09

3.91

0

0

0

0

0

0

C10

6.25

1

1

2

3

7

35

C11

10

5

5

5

5

20

100

 

Table 3: Analytical results

Treatment

Control

Test substance

ID

C05

C06

C07

C08

C09

C10

C11

Actual loading rate [mg test item.L-1]

0

0.92

1.72

2.41

4.03

6.19

10.29

0h  analyzed concentrati on

[mg monoester.L-1]

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

0.599

0.365

[mg diester.L-1]

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

1.981

48h analyzed concentrati on

[mg monoester.L-1]

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

[mg diester.L-1]

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

Limit of quantification (LOQ) =0.1 mg.L-1 for monoester, and 0.5 mg.L-1 for diester.

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
For further details please refer to “Any other information on results incl. tables”.