(2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide

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:

3 december 2008-20 january 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Despite the lack of analytical monitoring data, it can be reasonably assumed that the test concentrations remained stable over the test duration from the analytical measurements reported in the long-term toxicity test to Daphnia magna performed on a structural analogue substance (Höger, 2013).

Qualifier:

according to guideline

Guideline:

other: ISO 14669 (1999) Water Quality - Determination of acute lethal toxicity to marine copepods (Copepoda; Crustacea)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: the test solutions were prepared using dilution series and without using of any organic solvent.
- Stock solution: 1.001 g test item in 1000 ml treated water in order to obtain a nominal concentration of 1000 mg/L.
- Controls: treated seawater without test item.
- Reference vessels: solutions of 3,5 dichlorophenol at 0.1, 0.32, 1.0, 1.8 and 3.2 mg/L.
- Evidence of undissolved material (e.g; precipate, surface film, etc): no.

Test organisms (species):

other: Acartia tonsa

Details on test organisms:

TEST ORGANISM
- Common name: Acartia tonsa.
- Strain: CCAP 1077/5.
- Source: Initially received from Dunstaffnage Marine Laboratory (1995).
- Age at study initiation (mean and range, SD): 19 days old at the beginning of the test.
- Food and feeding: the cultures were maintained on a mixed algal diet comprising of between 2 and 4 species. The test animals were not feed during the test.

ACCLIMATIZATION: no acclimatization.

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

18.4-19.4

pH:

Test item vessels: 7.99-8.14 (at 0h)
Control and reference vessels: 8.10 - 8.16 (at the end of the test)

Dissolved oxygen:

96-98%

Salinity:

35‰ (salinity measurement in dilution water at the beginning of the test)

Nominal and measured concentrations:

Nominal concentrations: 10, 32, 100, 320 and 1001 mg test item/L (corresponding to ca. 3, 9.6, 30, 96 and 300 mg active content/L).

Details on test conditions:

TEST SYSTEM
- Test vessel:
-- Type: Borosilicate glass conical flasks;
-- Material, size, headspace, fill volume: 100-mL flasks, filled with 50mL of test medium seawater, covered with soda glass watch.
- No. of organisms per vessel: 10.
- No. of vessels per concentration (replicates): 2.
- No. of vessels per control (replicates): 1.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: natural seawater supplied by pump from Scapa Flow, Orkney. Seawater is UV sterilised and filtered to 0.2 µm.
- Culture medium different from test medium: no.
- Seawater quality criteria: measurements of water quality was carried out in one replicate at each concentration at 0h and 48h.

OTHER TEST CONDITIONS
- Adjustment of pH: no.
- Photoperiod: no data.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
The immobility of the daphnids was determined by visual inspection after 24 and 48 hours of exposure.

TEST CONCENTRATIONS
- Preliminary range-finding test: 1 - 10 - 100 - 1000 mg/L (nominal, test item).
- Definitive test: 10 – 32 – 100 - 320 - 1001 mg/L (nominal, test item).
- Reference substance: 0.10 - 0.32 - 1.0 - 1.8 - 3.2 mg/L (nominal, 3,5-dichlorophenol).

Reference substance (positive control):

yes

Remarks:

3,5-dichlorophenol

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

66.75 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CL = 36.02-82.05 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 20 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

- Biological results at 24h and 48h exposure (test item): see results on table 2 below.
- Biological results at 48h exposure (3,5-DCP and control media): see results on table 3 below.

The following validity criteria are fulfilled:
* Mortality of controls is less than 10% at the end of the test
* Test conditions (pH, temperature, salinity) were maintained during the test
* The oxygen saturation was maintained during the test and was above 80% of oxygen saturation

There is a lack of information of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, the test has been performed under static conditions during 48 hours and according to the long-term toxicity test to Daphnia performed on a very similar substance, the substance is stable during 48 hours. Thus, we can consider that in a short-term study, the substance is also stable.

For details see table 1 in ‘Any other information on results incl. tables’

Results with reference substance (positive control):

For evaluation of the quality of the aquatic organisms and the experimental conditions, 3,5-dichlorophenol was used as a positive control.
48h LC50 = 0.96 mg/L with 95% confidence limits : 0.13-3.02 mg/L)
(See results on tables 2 and 4 below)

Reported statistics and error estimates:

LC50 and NOEC were calculated using an appropriate statistical method from the ToxCalc Version 5 Software.

Table 1: Summary of guideline criteria and values during test

 

Parameter	Guideline criterion	Observed values
pH of dilution water at 0h	8±0.3	7.97
pH at 0h	6-9	7.99-8.14
Temperature (°C)	20 ±2 °C	18.4-19.4
Dissolved oxygen (%)	≥80	96-98
Salinity at 0h in dilution water (‰)	36±4	35
Informal reference toxicant 48h LC50 (mg/L)	0.4-1.5	0.96
Control mortality (%)	≤10	4.9

 

 Table 2 - Mortality of Acartia after 24h and 48h exposure

Concentration (mg/L)	Number / dead immobile at 24h		Number / dead immobile at test termination		Total exposed	Proportional response
	Replicate a	Replicate b	Replicate a	Replicate b		24h	48h
10	0	0	1	0	20	0.00	0.05
32	0	1	3	2	23	0.04	0.22
100	7	9	9	9	22	0.73	0.82
320	11	10	11	10	21	1.00	1.00
1000	10	11	10	11	21	1.00	1.00

Table 3 - Mortality of Acartia after 48h exposure to 3,5 DCP and control media

Concentration (mg/L)	Number dead / immobile		Total exposed	Proportional response 48h
	Replicate a	Replicate b
Control 1	1		11	0.09
Control 2	1		10	0.10
Control 3	0		10	0.00
Control 4	0		10	0.00
0.10	1	0	20	0.05
0.32	2	0	20	0.10
1.0	7	4	20	0.55
3.2	10	10	20	1.00

 

Validity criteria fulfilled:

yes

Conclusions:

The test item exhibited adverse effects on Acartia tonsa at nominal concentrations of 32 mg/L and higher. The 48h-EC50 value was determined to be 66.75 mg test item/L (corresponding to ca. 20 mg active content/L).

Executive summary:

The short-term aquatic toxicity of the REACh substance (2-Hydroxy-3-sulphopropyl) dimethyl[3-[(1-oxododecyl) amino]propyl]ammonium hydroxide (EC 242-893-1) was investigated in a GLP-compliant study performed with the marine crustacean species Acartia tonsa in accordance with ISO 14669:1999 (Water Quality - Determination of Acute Lethal Toxicity to Marine Copepods (Copepoda; Crustacea)). The test item exhibited adverse effects on Acartia tonsa at nominal concentrations of 32 mg test item/L and higher. The 48h-EC50 value was determined to be 66.75 mg test item/L (corresponding to ca. 20 mg active content/L).

Description of key information

The short-term aquatic toxicity of the REACh substance was investigated in a GLP-compliant study (Hudson, 2009) performed with the marine crustacean species Acartia tonsa in accordance with ISO 14669:1999 (Water Quality - Determination of Acute Lethal Toxicity to Marine Copepods (Copepoda; Crustacea)). The test item exhibited adverse effects on Acartia tonsa at nominal concentrations of 32 mg test item/L and higher. The 48h-EC50 value was determined to be 66.75 mg test item/L (corresponding to ca. 20 mg active content/L).

NB. In case the solid content of the test item was not reported in a study report, ECx values were expressed in active content. If relevant, these values were used for the chemical safety assessment (worst-case values).

Key value for chemical safety assessment

Marine water invertebrates

Marine water invertebrates

Effect concentration:

20 mg/L

Additional information

The short-term toxicity to marine invertebrate species of the substance EC 242-893-1 was investigated in a GLP-compliant study (Hudson, 2009) performed in accordance with standard methods, without deviations. The study is considered as reliable with restrictions (Klimisch 2) and was selected as key study for the endpoint.