9-Octadecenoic acid (Z)-, ester with oxybis[propanediol] (2:3)

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 Jan - 24 Jan 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 13, 2004

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, ester with oxybis[propanediol] (2:3)

EC Number:

289-147-1

EC Name:

9-Octadecenoic acid (Z)-, ester with oxybis[propanediol] (2:3)

Cas Number:

86088-80-4

Molecular formula:

not applicable, the substance is UVCB

IUPAC Name:

9-Octadecenoic acid (Z)-, ester with oxybis[propanediol] (2:3)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all concentration levels and control
- Sampling method: Approx. 10 mL of test solution was sampled from the middle layer of each test vessel. Sampling was performed at the start of exposure, before and after the renewal at 24 h and at the end of exposure.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The treatment solutions were prepared as water accommodated fractions (WAFs). The test sample and dilution water were mixed to prepare each nominal loading rate and subsequently stirred for 48 hours. The suspensions were filtered with a membrane filter (0.45 µm pore size). The stirred filtrates were used as test solutions.
- Eluate: no
- Differential loading: yes
- Controls: blank control, reference control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): After filtration, the test solutions were clear.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: The University of Sheffield, United Kingdom; supplied on July 9, 1990
- Age of parental stock: 20 d
- Feeding during test: no
- Breeding conditions of parental stock: breeding in dechlorinated tap water at 20 ± 1 °C; photoperiod: 16 h light/8 h darkness; survival of parental stock: 95%; during breeding, the daphnids were fed Chlorella vulgaris once a day (corresponding to 0.1-0.2 mg organic carbon per day)
- Age of daphnids for test: less than 24 h

ACCLIMATION
- Acclimation period: not specified

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

32 mg/L (Ca, Mg)

Test temperature:

20.0 - 20.1 °C

pH:

7.8 - 7.9

Dissolved oxygen:

Control: 7.8 - 8.6 mg/L
Treatment: 7.3 - 8.6 mg/L

Conductivity:

13 mS/m

Nominal and measured concentrations:

nominal: Control, 9.5, 17, 31, 56 and 100 mg/L
measured: < detection limit, 0.936, 7.45, 13.4, 33.0 and 61.2 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beaker, covered with transparent plastic lid
- Renewal rate of test solution: fresh test solutions were prepared after 24 h
- Aeration: no
- 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: dechlorinated tap water
- Total organic carbon: < 0.5 mg/L
- Particulate matter: < 1 mg/L
- Chlorine: < 0.02 mg/L
- Alkalinity: 36 mg/L
- Ca/mg ratio: 4.14
- Conductivity: 13 mS/m
- Culture medium different from test medium: same as test medium
- Intervals of water quality measurement: pH value, temperature and dissolved oxygen concentration were measured at test start, before and after the renewal at 24 h and at test end

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Immobility and behavioural effects were observed after 24 and 48 h.

RANGE-FINDING STUDY
- Concentrations: 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: After 48 h, 10% immobility was observed at a nominal concentration of 100 mg/L.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate; tested regularly

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 61.2 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Remarks on result:

other: 95% CI not determined

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Remarks on result:

other: 95% CI not determined

Details on results:

- Behavioural abnormalities: No immobility and no abnormal behaviour was observed at any exposure level.
- Immobility of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No, the test solutions were clear and colourless at test start and end.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50 (48 h) = 0.12 mg/L (mean ± 2 S.D.: 0.10 - 0.35 mg/L)

Reported statistics and error estimates:

Since no more than 50% immobility could be obtained in any exposure level, the EC50 was estimated as ">maximum test concentration". The estimation of the EC50 was performed based on the geometric mean of the measured concentration of the test solution during exposure.

Any other information on results incl. tables

Table 1: Immobility

Measured concentration [mg/L]	Vessel	24 hours		48 hours
		No. of immobilied daphnids/Total daphnids	Immobility [%]	No. of immobilied daphnids/Total daphnids	Immobility
Control	A	0/5	0	0/5	0
	B	0/5		0/5
	C	0/5		0/5
	D	0/5		0/5
0.936	A	0/5	0	0/5	0
	B	0/5		0/5
	C	0/5		0/5
	D	0/5		0/5
7.45	A	0/5	0	0/5	0
	B	0/5		0/5
	C	0/5		0/5
	D	0/5		0/5
13.4	A	0/5	0	0/5	0
	B	0/5		0/5
	C	0/5		0/5
	D	0/5		0/5
33.0	A	0/5	0	0/5	0
	B	0/5		0/5
	C	0/5		0/5
	D	0/5		0/5
61.2	A	0/5	0	0/5	0
	B	0/5		0/5
	C	0/5		0/5
	D	0/5		0/5

 

Table 2: Measured concentrations of the test item in test solutions

Nominal concentration	Measured concentration [mg/L]
	Percentage of measured concentration versus that at each preparation [%]
	At test start	24 hours		At test end	Geometric mean
		Before renewal	After renewal
Control	n.d.	n.d.	n.d.	n.d.	-
9.5	1.70	0.679 (39.9)	0.994	0.668 (67.2)	0.936
17	6.46	5.90 (91.4)	8.98	9.02 (100)	7.45
31	14.1	12.5 (88.5)	13.3	13.9 (104)	13.4
56	31.8	29.7 (93.5)	34.5	36.2 (105)	33.0
100	68.5	63.0 (92.0)	56.9	57.2 (100)	61.2

Table 3: Validity criteria

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%	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	≥7.3 mg/L	yes

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.