1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3december 2008-23 january 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed according to an international guideline and according to GLP. The validity criteria were fulfilled except the lack 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 semi-static conditions and according to the long-term toxicity to Daphnia, the substance is stable during 48 hours. Thus, we can considered that in a short-tem study, the susbtance is also stable.

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 without using of any organic solvent
- Stock solution : 0.10008 g test item in 1000 ml treated water in order to obtain a nominal concentration of 100.08 mg/L
- Controls : treated seawater without test item
- 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:

18.2-19.4

pH:

7.99-8.41

Dissolved oxygen:

89-98

Salinity:

35 perthousand (salinity measurement in the control medium at the beginning of the test)

Nominal and measured concentrations:

100.08 mg/L - 56 mg/L - 32 mg/L - 18 mg/L and 10 mg/L (nominal concentrations)

Details on test conditions:

TEST SYSTEM
Test vessel:
- Material, size, headspace, fill volume: 100 ml capacity borosilicate glass crystallising dishes, each containing 50 ml of test medium covered with soda glass watch covers
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): -


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
- Ajustment 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 :
- test concentrations :1 - 10 - 100 - 1000 mg/l

- Definitive test :
- test concentrations :10 - 18 - 32 - 56 - 100.08 mg/l

- Reference substance :
Nominal tested concentrations : 0 - 10 - 0.32 - 1.0 - 1.8 and 3.2 mg/L

Reference substance (positive control):

yes

Remarks:

,5-dichlorophenol

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

13.24 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% confidence limits = 12.27 – 14.18 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

6.62 mg/L

Nominal / measured:

nominal

Conc. based on:

other: solid content

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

5.56 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

< 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

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)

Results with reference substance (positive control):

For evaluation of the quality of the aquatic organisms and the experimental conditions, 3,5-dichlorophenol is tested 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)

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	1	2	2	2	20	0.15	0.20
18	10	10	10	10	20	1.00	1.00
32	10	13	10	13	23	1.00	1.00
56	10	10	10	10	20	1.00	1.00
100	10	10	10	10	20	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:

not specified

Conclusions:

Immobilization was observed after 24 h and at test termination. The 48h-EC50 was 13.24 mg test item/L (corresponding to 6.62 mg solid content/L and 5.56 mg active content/L) expressed as nominal concentrations.

Executive summary:

The acute toxicity of the test item (= substance EC 939-455-3 in aqueous commercial product) to the marine crustacean species Acartia tonsa was investigated in a GLP-compliant study performed in accordance with ISO 14669 Standard (Determination of Acute Lethal Toxicity to Marine Copepods). The 48-hour 50% effective concentration EC50 (immobilization) of the test item was found to be 13.24 mg/L (corresponding to 6.62 mg solid content/L and 5.56 mg active content/L) based on nominal concentrations.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

25 august 2006 - 11 october 2006

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: - No characterization of the tested item - No information concerning the 48h -LC50 of the reference substance - no enough information concerning the physical measurements (pH, temperature, dissolved oxygen)

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION :
- Method : the test solutions were prepared without using of any organic solvent
- Stock solution : 1.0 g/L stock solution was prepared in seawater
- Controls : treated seawater without test item
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No data

Test organisms (species):

other: Acartia tonsa

Details on test organisms:

TEST ORGANISM
- Common name : Acartia tonsa
- Source : Initially received from Guernsey Sea farms, Guernsey
- Age at study initiation (mean and range, SD) : 15-17 days old
- Food and feeding :no data

ACCLIMATIZATION : no data

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

no data

Test temperature:

no data

pH:

no data

Salinity:

no data

Nominal and measured concentrations:

Range-finding test :
Nominal concentrations : 2.0, 20.0, and 200.0 mg/L

Definitive test :
Nominal concentrations : 2.0, 3.56, 6.32, 11.25 and 20.0 mg/L

Details on test conditions:

TEST SYSTEM
Test vessel:
- Material, size, headspace, fill volume: no data
- No. of organisms per vessel: no data
- No. of vessels per concentration (replicates): no data
- No. of vessels per control (replicates): no data
- No. of vessels per vehicle control (replicates): -


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water : Natural seawater provided by Guernsey Sea Farms. .
- Culture medium different from test medium : No
- Seawater quality criteria :The temperature on arrival was 20°C, pH 7.94, salinity 33.6 g/L and the Dissolved Oxygen level 100%.
The seawater was stored at 20 +/-2°C

OTHER TEST CONDITIONS
- Ajustment of pH : No data
- 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 :
- test concentrations :2 - 20 - 200 mg/l

- Definitive test :
- test concentrations :2.0 - 3.56 - 6.32 - 11.25 - 20 mg/l

- Reference substance :
Nominal tested concentrations : 1 mg/L

Reference substance (positive control):

yes

Remarks:

3,5-Dichlorophenol

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

10.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 8.2-13.3 mg/l

Details on results:

24h-EC50 : 16.8 mg/L
48h-EC50 : 10.4 mg/L

Results with reference substance (positive control):

No result possible.
In the report, it is just indicated that the reference substance (2,5-DCP) was testetd at 1 mg/L. At this concentration, 100% mortality observed at 24 and 48 hours test period.

Reported statistics and error estimates:

The mortality data calculated at each observation period was processed using the statistical computer programme Toxcalc, supplied by tidepool Scientific (STL Runcorn SOP V;2). Toxcalc is udes to derive the median effect concentration (LC50) which kils 50% of the animals exposed to test material, together with 95% fiducial limits and No Observed Effect Concentration (NOEC) and lowest Observed Effect Concentration (LOEC)

Validity criteria fulfilled:

no

Executive summary:

The acute toxicity of the test item to the marine crustacean Acartia tonsa was investigated in a GLP-compliant study performed in accordance with ISO 14669 Standard (Determination of Acute Lethal Toxicity to Marine Copepods). The 48-hour 50% effective concentration (immobilization) of the test item was found to be 10.4 mg/L.

The study is considered as not reliable due to major methodological deficiencies and insufficient documentation:

- no characterization of the tested item;

- lack of information on test organisms and test conditions (lenght, loading, feeding);

- no enough informations concerning the experimental conditions (pH, temperature, dissolved oxygen);

- no information concerning the 48h-LC50 of the reference item.

For these reasons, the report is considered with a klimish category 3

Description of key information

The acute toxicity to the marine crustacean species Acartia tonsa of the substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-455-3) was investigated in a GLP-compliant study (Hudson, 2009) performed in accordance with ISO 14669 Standard (Determination of Acute Lethal Toxicity to Marine Copepods). The 48-hour EC50 (immobilization) of the substance was found to be 6.62 mg solid content/L based on nominal concentrations. The acute toxicity to aquatic crustacean species was investigated in one other study (Rendell, 2006) which was not considered in the assessment due to major methodological deficiencies and insufficient documentation.

Key value for chemical safety assessment

Marine water invertebrates

Marine water invertebrates

Effect concentration:

6.62 mg/L

Additional information

The acute toxicity to crustacean species of the substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-455-3) 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. The other available study (Rendell, 2006) is considered as not reliable (Klimisch 3) and was disregarded for the endpoint.