Octadecylamine

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

C16-18-(even numbered, saturated and unsaturated)-alkylamines

EC Number:

627-034-4

Cas Number:

1213789-63-9

Molecular formula:

R-NH2 R = alkyl mainly C16-18-(even numbered, saturated and unsaturated)-alkyl

IUPAC Name:

C16-18-(even numbered, saturated and unsaturated)-alkylamines

Test material form:

not specified

Details on test material:

Chemical name: Amines, C12-18-(even numbered) and C18-(unsaturated) alkyl
EC no.: 701-068-0

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Dispersion treatment: Stock solution was 5 mg/L. 6 μL/L test item were applied to 3 L natural river water. This solution was treated for 30 minutes with ultrasound at 40 °C. After a cooling period of 10 minutes the test item concentrations were prepared out of this stock solution.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Daphnia magna STRAUS (Clone 5)
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu); Breeder DR.U.NOACK-LABORATORIEN, D-31157 Sarstedt, Germany
- Age at study initiation: 2 - 24 h old
- Feeding during test: The daphnids were not fed during the study.

HOUSING:
- Conditions: In 2-3 L glass vessels with approximately 1.8 L culture medium, at 21 °C (temperatures of 20 - 25 °C are tolerated), in an
incubator, 16 h illumination, illumination strength max. 20 μE⋅m-2 ⋅s-1.
- Culture medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L.
- Type and amount of food: Feeding ad libitum with a mix of Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of > 106 cells/mL.
- Feeding frequency: 5x weekly



ACCLIMATION
- Acclimation period: At least 2 h in dilution water

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

131.4 mg CO3/L

Test temperature:

18 - 22 +/- 1 °C

Nominal and measured concentrations:

Nominal concentrations: 5.00 - 2.00 - 0.80 - 0.32 - 0.123 - 0.051 mg/L (factor 2.5)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, fill volume: Glass beakers (5 cm ID x 8 cm H), 50 mL; Volume of the study medium is 20 mL
- 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: A natural occurring river water (River Böhme) was used as test medium.
Test water parameter:
pH: 7.68
Conductivity [μS/cm]: 451
DOC [mg C/L]: 6.3
TOC [mg C/L]: 7.1
Ammonium-N [mg N/L]: < 1.94
Nitrate-N [mg N/L]: 3.9
o-Phosphate-P [mg P/L]: 0.029
Total Phosphate [mg P/L]: 0.080
Suspended Matter [mg/L]: 16.9
Total Hardness [mg CO3/L]: 131.4
- Culture medium different from test medium: yes
- Intervals of water quality measurement: Prior to test start (0 h) pH-value, dissolved oxygen concentration, temperature, conductivity and total hardness of the dilution water were measured. At the beginning of the test water parameters (pH value, oxygen concentration) were measured in one additional replicate per concentration and control. After 48 h the water parameters in old media were measured in all replicates per concentration and control. The room temperature was recorded throughout the test with a thermohygrograph.


OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: Diffuse light, illumination range max. 20 μE⋅m-2 ⋅ s-1


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The percentage immobility was determined in all test and control groups after 24 h and 48 h.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate p.a. (MERCK)

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.98 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

0.76 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Effect concentrations exceeding solubility of substance in test medium: The test item was clearly dissolved in the tested concentrations throughout exposure. A slight yellowish coloration and brown particles were visible in the test media and on the ground of the test vessels.

Results with reference substance (positive control):

EC50 after 24 hours is 1.99 mg/L

Any other information on results incl. tables

Table1: Percentage of Daphnids incapable of swimming after 24 and 48 h of exposure with (Z)-octadec-9-enylamine:

Nominal conc.(mg/l)	IMMOBILISATION [%]
	24 h					48 h
	Replicates					Replicates
	1	2	3	4	MW	1	2	3	4	MW
5.00	100	100	100	100	100	100	100	100	100	100
2.00	20	20	40	40	30	100	100	100	100	100
0.80	0	0	0	0	0	0	20	20	20	15
0.32	0	0	0	0	0	0	0	20	0	5
0.128	0	0	0	0	0	0	0	0	0	0
0.051	0	0	0	0	0	0	0	0	20	5
Control	0	0	0	0	0	0	0	0	0	0

Table 2: Concentrations of (Z)-octadec-9-enylamine:

Nominal test item conc. [mg/L]	Meas. conc. [mg/L]after 0 h	Meas. conc. [mg/L]after 48 h
5.00	3.8	0.16
2.00	1.5	0.05
0.80	0.64	0.02
0.32	0.26	< detection limit
0.128	0.12	< detection limit
0.051	0.05	< detection limit
Control	< detection limit	< detection limit

Applicant's summary and conclusion

Conclusions:

The total amount of test item recovered from the stock solution and glassware (aqueous phase
and adsorption to glass) indicated that adsorption to glass amounted to 43 % of the applied test
item. The stock solution aqueous phase had a concentration at 75 % of nominal. Therefore a
correction was applied.
The measured initial concentrations in the test replicates (0 h) showed a good accordance with
the geometrical series of dilution for the concentration range of 0.32 – 5.00 mg/L. The two
lowest concentrations showed slightly higher recoveries. After a 48 h exposure all
concentrations had decreased. The three lowest concentrations had dropped below the limit of
quantification (10 μg/L). The three highest concentrations showed recoveries in the range of 3 –
4 %.
The adsorption of the test item to glassware used during the test was quantified at the two
concentrations which framed the EC50 (0-48 h). As expected, (Z)-Octadec-9-enylamine showed
a limited adsorption to glassware (Table 13). The amount recovered from the glassware did not
exceed 11 % of the applied amount. These results indicate that adsorption to glassware
contributes only little to the observed decrease of the test item during the test. Under test
conditions with natural river water, adsorption to glass can be considered negligible.
Other effects must have caused the observed decrease of concentration in the aqueous
phases. Adsorption to humic acids, suspended matter or daphnia surfaces are the most likely
mechanisms.

Executive summary:

The Acute Immobilisation of the test item (Z)-Octadec-9-enylamine (batch number: 89) to Daphnia magna (STRAUS) was determined according to OECD Guideline 202 / EC 92/69/EC Method C.2 from 2006-03-01 to 2006-03-03 at DR.U.NOACK-LABORATORIEN, D-31157 Sarstedt, Germany. The study was conducted with 6 nominal concentrations ranging from 0.051 to 5.00 mg/L in a geometric series with a factor of 2.5 under static conditions over a duration of 48 h. 20 test organisms were exposed to each test concentration and control. The water quality parameters pH-value and dissolved oxygen concentration were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled. All concentration levels and the control groups were analytically verified via LC-MS/MS after 0 h (new media) and 48 h (old media). Measured initial concentrations in the test replicates (0 h) showed a good accordance with the geometrical series of dilution for the concentration range of 0.32 – 5.00 mg/L. The two lowest concentrations showed slightly higher recoveries. After a 48 h exposure all concentrations had decreased. The three lowest concentrations had dropped below the limit of quantification (10 μg/L). The three highest concentrations showed recoveries in the range of 3 – 4 % (for details of the analytical method and results please refer to chapter 9). The test item has a low water solubility and sorbs to organic and inorganic materials by different mechanisms. The sorption processes are mostly non-linear, means are concentration dependent. Due to these properties the test item is difficult to test in synthetic water (e.g. sorption to the test organism and walls of the test vessel) and results from such tests depend from the test settings applied. Using natural river water which contains particulate as well as dissolved organic carbon to which the test item can sorb partially reduces the difficulties encountered in tests with synthetic water e.g. preventing that the test item settles onto surfaces. The sorbed fraction of the test item is difficult to extract from the test system which normally leads to low analytical recoveries. Due to the short exposure period these low recoveries cannot be associated to biodegradation. This means the test substance is present in the test system and therefore available for exposure (dissolved in water and sorbed also called bulk). Due to the properties of the test item nominal concentrations have to be used instead of measured ones (see Table 1). This so called Bulk Approach is described by ECETOC (2003). Sorption of the test item to the glass ware of the test system was monitored and found to be small.