Oleic acid, compound with (Z)-octadec-9-enylamine (1:1)

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:

15 Nov 2017 - 20 Feb 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:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid, compound with (Z)-octadec-9-enylamine (1:1)

EC Number:

248-813-1

EC Name:

Oleic acid, compound with (Z)-octadec-9-enylamine (1:1)

Cas Number:

28065-97-6

Molecular formula:

C34H69NO2 C36H67NO2 C36H69NO2 C36H71NO2 C36H73NO2

IUPAC Name:

oleic acid, compound with (Z)-octadec-9-enylamine (1:1)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all test item concentrations and the control
- Sampling method: The level of TOC (total organic carbon) measured in freshly prepared test media specimens and aged (after 2 days) test media specimens, were compared against the carbon content of the test item to derive the concentrations of test item at each time point. The suitability of the carbon analyser was cross-checked with a second carbon analyser at 0.5 mg/L TOC.
- Sample storage conditions before analysis: the specimens were stored at 2 - 8 °C

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was weighed into ELENDT M4 dilution water followed by shaking on a shaking machine for 24 h being necessary to dissolve the test item sufficiently in the test medium. Thereafter the suspensions were passed over glass fibre filters and membrane filters (0.45 µm pore size) in order to separate the non-dissolved fractions from the dissolved fractions. The clear eluates were used directly without any further dilution steps.
- Controls: Yes

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain/clone: STRAUS, clone 5
- Source: Originally derived from the lnstitut National de Recherche Chimique Appliquee, France in 1978
- Age of parental stock: Not older than 24 h
- Feeding during test: No

ACCLIMATION
- Acclimation period: Cultivation of the daphnia is performed in a way that the animals are transferred in new test medium at an interval of 1 to 3 days.
- Acclimation conditions: Same
- Type and amount of food: Desmodesmus subspicatus- and/or Chlorella-cells
- Feeding frequency: An interval of 1 to 3 days

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Daphnias used for the test are not older than 24 h. Therefore, in every case, daphnia are transferred into fresh medium one day before starting of the daphnia test in order to get daphnia for the test younger than 24 h.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

20.2 - 20.8 °C (Control)
20.8 - 20.9 °C (Test Item Concentrations)

pH:

8.22 - 8.23 (Control)
8.12 - 8.37 (Test Item Concentrations)

Dissolved oxygen:

6.8 - 8.7 mg O2/L (Control)
6.9 - 7.8 mg O2/L (Test Item Concentrations)

Nominal and measured concentrations:

Control, 10, 20, 40, 80, 160 mg/L (nominal)
Control, 0.17, 0.15, 0.09, 0.20 and 0.19 mg/L (actual concentrations, based on the geometric mean)

Details on test conditions:

TEST SYSTEM
Test vessel:
- Type: open
- Material, size: 100 mL glass carboys
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 5

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to the guideline OECD 202
- Culture medium different from test medium: No
- Intervals of water quality measurement: Test start and test end

OTHER TEST CONDITIONS
- Photoperiod: 16 h of light and 8 h of darkness.

EFFECT PARAMETERS MEASURED: Mobility of the daphnia; examined by the determination of the swimming behavior of the daphnids after gentle agitation.

RANGE-FINDING STUDY
- Test concentrations: 1.0; 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: Based on the results of the screening test the test item concentration range of the main test was performed.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

78 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: 95% confidential limits

Remarks:

63.9 – 95.8 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

other: EL20

Effect conc.:

52.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: 95% confidential limits

Remarks:

38.0 – 64.1 mg/L

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EL10

Effect conc.:

42.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: 95% confidential limits

Remarks:

28.0 – 53.7 mg/L

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no

Results with reference substance (positive control):

The reference substance was tested twice a year. The value of the EC50 (24 h) was at 1.07 mg/L potassium dichromate. This value is in accordance with the recommendations of 0.6 to 2.1 mg/L K2Cr2O7 given in OECD Guideline 202 (Daphnia sp., Acute Immobilisation Test)

Reported statistics and error estimates:

Effect concentrations are given below. Statistical evaluation was done using the commercial computer program ToxRat Professional Version 3.2.1

Any other information on results incl. tables

Table 1: Biological Results

Nominal Concentration of the test item (mg/L)		Ratio immobilised Daphnia [%]
		24 h	48 h
Control (0)		0 [0/20]	0 [0/20]
10		0 [0/20]	0 [0/20]
20		0 [0/20]	0 [0/20]
40		0 [0/20]	15 [3/20]
80		0 [0/20]	35 [7/20]
160		0 [0/20]	100 [20/20]

Numbers in brackets give the absolute numbers of immobilised animals at each concentration.

Table 2: Effective Concentrations on Basis of the Nominal Concentrations:

Endpoints	Basis: Nominal Concentrations [mg “Oleylamine Oleate“/L] (“WAF”)
	t24 h	t48 h
NOEL	≥160	20
LOEL	>160	40
EL10	n.d. (>160)	42.7 [28.0 – 53.7]
EL20	n.d. (>160)	52.5 [38.0 – 64.1]
EL50	n.d. (>160)	78.0 [63.9 – 95.8]

Tabel 3: Analytical Results

Values Time t0	Nominal Concentrations
	Control	10 mg/L	20 mg/L	40 mg/L	80 mg/L	160 mg/L
Measured TOC (NPOC) [mg/L]	0.157	0.454	0.321	0.286	0.404	0.368
	0.199	0.238	0.272	0.234	0.351	0.307
	0.158	0.297	0.266	0.216	0.293	0.332
	0.230	0.433	0.369	0.279	0.349	0.381
	0.242	0.288	0.341	0.251	0.308	0.342
	0.149	0.283	0.254	0.251	0.301	0.294
Mean Values	0.189	0.332	0.304	0.253	0.334	0.337
Net-Control	0.000	0.143	0.114	0.064	0.145	0.148

 

Values Time t48 h	Nominal Concentrations
	Control	10 mg/L	20 mg/L	40 mg/L	80 mg/L	160 mg/L
Measured TOC (NPOC) [mg/L]	0.208	0.325	0.329	0.327	0.354	0.395
	0.127	0.254	0.251	0.239	0.306	0.294
	0.105	0.287	0.266	0.225	0.310	0.312
	0.234	0.334	0.319	0.250	0.381	0.367
	0.193	0.296	0.300	0.232	0.313	0.303
	0.153	0.279	0.268	0.212	0.331	0.281
Mean Values	0.170	0.296	0.289	0.248	0.333	0.325
Net-Control	0.000	0.126	0.119	0.077	0.162	0.155

Table 4: 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.	No mortality	Yes
The dissolved oxygen concentration at the end of the test should be≥3 mg/L in control and test vessels.	≈5 mg O2/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”

Conclusions:

The EL50 was determined to be at 78.0 mg/L after 48 h and the NOEL was observed to be at 20 mg/L.