Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-06-05 to 2007-06-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Samples of fresh and aged test solutions were taken from fresh media at test start and renewal and in aged media at renewal (24 h) and test end (48 h). The samples were stored frozen (–18°C, ± 2°C) until analysis.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: clone V
- Source: Originally obtained from German Federal Environment Agency, Institut für Wasser-, Boden- und Lufthygiene. Specimens used in the test were bred in the laboratory of the Fraunhofer IME.
- Age at study initiation (mean and range, SD): 4–24 h
- Method of breeding: Adult Daphnia, at least 3 weeks old, were separated from the stock population by sieving. Batches of 30 to 50 animals are held at room temperature in ca. 1.8 L dilution water for one week. During this week the daphnids are fed daily with an algal suspension (Desmodesmus subspicatus) and LiquizellR (HOBBY). Algae growing in the log-phase were centrifuged and the pellet was re-suspended in a few mL of medium. 30 mL of this suspension was given to 1 L Daphnia medium. The water was changed once per week. Newborn Daphnia were separated by sieving, the first generation was discarded.
- Feeding during test: no

ACCLIMATION
Not reported

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

0.7–0.8 mmol/L (Ca-hardness 0.4–0.5, Mg-hardness 0.2–0.4)

Test temperature:

20.2–20.4 °C

pH:

7.6–8.4

Dissolved oxygen:

7.5–8.5 mg/L

Nominal and measured concentrations:

Nominal: 11.97, 20.35, 34.60, 58.82, and 100.00 µg a.i./L
Time weighted mean measured concentration: 3.29, 6.45, 10.87, 26.98, and 74.29 μg a.i./L (27.5 %, 31.7 %, 31.4 %, 45.9, and 74.3 % of nominal).

Details on test conditions:

TEST SYSTEM
- Fill volume: 50 mL
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): test organisms were transferred in new test vessels with freshly prepared test solutions after 24 hours.
- 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: Purified drinking water was used as holding- and dilution water. The purification included filtration with activated charcoal, passage through a limestone column, and aeration. To avoid copper contamination, plastic water pipes are used for the testing equipment.
The following water chemistry data are recorded regularly in the testing facility and are reported: pH, conductivity, dissolved oxygen content, content of nitrate, nitrite, ammonium (NH4+), phosphate, calcium, magnesium, total hardness, alkalinity, DOC content, content of metals (copper, iron, manganese and zinc).


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h [light:dark]
- Light intensity: The light intensity was measured using an illuminance meter (MINOLTA) with a photometric sensor in Lux: 534–571 lx (corresponding to 9.5–10.2 µE/m²/s)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility (after 24 and 48 h)

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

33.3 µg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: 95% CL = 26.05–42.57 µg/L

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

15.86 µg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other:

Remarks:

95% CL = 11.21-22.45 µg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

10.87 µg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

26.98 µg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50/LC50: EC50 = 0.83 mg/L (95% CL: 0.73–0.94)

Table A7.4.1.2-23:Measured concentrations of the four lead compounds (sum) in fresh and aged test media and time weighted mean, extrapolated to total active substance (a.s.);lead compounds represent 65.92 % of total a.s.

Nominal conc. of lead compounds (µg/L)	Day 0		Day 1		Day 1		Day 2		Extrapolated time weighted mean (total a.s.)
	Fresh (µg/L)	% nom.	aged (µg/L)	% nom.	aged (µg/L)	% nom.	aged (µg/L)	% nom.	(µg a.s./L)	% nom.
2.17	3.14	39.8	0.68	8.7	5.65	71.6	1.05	13.3	3.29	27.51
4.25	5.91	44.0	1.98	14.8	8.46	63.0	2.52	18.8	6.45	31.67
7.17	9.16	40.2	3.12	13.7	12.86	56.4	5.59	24.5	10.87	31.42
17.79	33.19	85.6	9.13	23.6	28.02	72.3	9.24	23.8	26.98	45.87
48.97	51.16	77.6	23.91	36.3	90.48	137.3	40.42	61.3	74.29	74.29

 

Table A7.4.1.2-24:Immobilisation after 24 h and 48 h; a.s. = active substance; concentrations given as mean measured concentrations.

Replicate	Time	Control	3.29 µg a.s./L	6.45 µg a.s./L	10.87 µg a.s./L	26.98 µg a.s./L	74.29 µg a.s./L
	24 h
1		0	0	20	0	0	20
2		0	0	0	0	0	20
3		0	0	0	0	0	100
4		0	0	0	0	0	20
	48 h
1		0	0	20	0	20	100
2		0	0	0	0	40	100
3		0	0	0	0	20	100
4		0	0	0	0	0	100

Validity criteria fulfilled:

yes

Conclusions:

The 48 h EC50 of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid in Daphnia magna was 33.30 µg a.i./L (95% CL 26.05–42.57 µg a.i./L).

Executive summary:

The influence of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid on immobilisation of Daphnia magna was investigated. For this, the daphnids were placed in water containing the test item in nominal concentrations of 59.87, 101.77, 173.01, 294.10, and 500.00 µg test item per litre, representing 11.97, 20.35, 34.60, 58.82, and 100.00 µg active substance per litre. The test was conducted under semi-static conditions with renewal of test media after 24 h. Effects on immobilisation were determined after 24 and 48 hours.

Test substance concentrations were determined by LC-MS/MS. Total active substance concentrations were extrapolated from the mean measured concentrations of four representative lead components.

Actual test concentrations (time weighted means) were determined to be 3.29, 6.45, 10.87, 26.98, and 74.29 μg a.s./L (27.5 %, 31.7 %, 31.4 %, 45.9, and 74.3 % of nominal).

No significantly increased mortality (NOEC) was detected when compared to the control up to mean measured concentrations of 10.87 µg/L. The EC50 was estimated at 33.30 µg a.s./L (measured).

Thus, the recalculated effect values for immobilization at test end (based on time-weighted mean measured concentrations) are

NOEC = 10.87 µg a.s./L

LOEC = 26.98 µg a.s./L

EC50(95% CL) = 33.30 µg a.s./L (26.05–42.57)

Description of key information

EC50 (48 h) = 33.30 µg a.i./L (mean measured, Daphnia magna, OECD guideline 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

33.3 µg/L

Additional information

The influence of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid on immobilisation of Daphnia magna was investigated according to OECD Guideline 202 (2004). For this, the daphnids were placed in water containing the test item in nominal concentrations of 59.87, 101.77, 173.01, 294.10, and 500.00 µg test item per litre, representing 11.97, 20.35, 34.60, 58.82, and 100.00 µg active substance per litre. The test was conducted under semi-static conditions with renewal of test media after 24 h. Effects on immobilisation were determined after 24 and 48 hours.

Test substance concentrations were determined by LC-MS/MS. Total active substance concentrations were extrapolated from the mean measured concentrations of four representative lead components.

Actual test concentrations (time weighted means) were determined to be 3.29, 6.45, 10.87, 26.98, and 74.29 μg a.i./L (27.5 %, 31.7 %, 31.4 %, 45.9, and 74.3 % of nominal).

No significantly increased mortality (NOEC) was detected when compared to the control up to mean measured concentrations of 10.87 µg/L. The EC50 was estimated at 33.30 µg a.i./L (measured).

Thus, the recalculated effect values for immobilization at test end (based on time-weighted mean measured concentrations) are

NOEC = 10.87 µg a.i./L

EC50(95% CL) = 33.30 µg a.i./L (26.05–42.57)