Dodecanoic acid, ester with 1,2-propanediol

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:

22 Oct - 25 Oct 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Reference 2

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

Test material information

Constituent 1

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”.