1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18(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:

From 25 november to 15 march 1994

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 lake 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:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

A stock solution was prepared in order to obtain a concentration of 100 ppm (w/w).
The tested concentrations were prepared by dilution of the stock solution.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnid, water flea (Daphnia magna Strauss 1820
- Strain: IRCHA
- Source: Laboratoire Ecotoxicologie du C.R.I.T. /D
- Length at study initiation: the test animals paased a mesh size of 800 µm but were detained in 560 µm mesh size
- Feeding during test: no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 - 21°C

pH:

8.4 (see table 1)

Dissolved oxygen:

95-96 (see table 1)

Nominal and measured concentrations:

nominal concentrations : 2.2, 3.4, 5.0, 7.5, 11, 15, 22, 34 and 50 ppm (w/w)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: 250 mL Pyrex glass beakers, fill volume 100 mL
- Aeration: No
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
bidistilled water conductivity µS/cm
CaCl2 * 2 H2O: 0.297 g/L
MgCl2 * 6 H2O: 0.167 g/L
NaHCO3: 0.200 g/L
K2SO4: 0.026 g/L
(pH at 21 °C immediately before use: 8.0)
pH and dissolved oxygen were measured after the incuvbation period of 24 h


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: incubation in the dark

EFFECT PARAMETERS MEASURED: immobility after 24 h

TEST CONCENTRATIONS
- Range finding test : 0.1, 0.35, 1.0, 3.5, 10, 35 and 100 ppm (w/w)
- Definitive Test : 2.2, 3.4, 5.0, 7.5, 11, 15, 22, 34 and 50 ppm (w/w)

Reference substance (positive control):

yes

Remarks:

Potassium dichromate, CAS 7778-50-9, analytical grade

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

9.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% confidence limits: 7.5 - 11 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.6 mg/L

Nominal / measured:

nominal

Conc. based on:

other: solid content

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Results with reference substance (positive control):

The test animals were sensible and a LD50 to potassium dichromate of 1.3 mg/L was obtained (details are reported in the annexof study report D 218).

Reported statistics and error estimates:

The LC50 was determined by the binomial method (original sofware of C.E. Stephan)

Table 1 - % immobilization at 24 and 48 hours

Initial concentrations mg/L *	Immobilization				O2	pH
	Number / 20		%
	24 h	48 h	24 h	48 h	48 h	48 h
Control	0	0	0	0	96	8.4
2.2	0	0	0	0	95	8.4
3.4	0	1	0	5	95	8.4
5.0	0	1	0	5	95	8.4
7.5	0	0	0	0	95	8.4
11	8	19	40	95	95	8.4
15	19	20	95	100	95	8.4
22	12	20	60	100	95	8.4
34	13	20	65	100	96	8.4
50	15	20	75	100	96	8.4

 

* in the report, expressed as ppm (w/w)

Validity criteria fulfilled:

yes

Conclusions:

The EC50-48h = 9.8 mg test item/L (95% C.L. 7.5-11 mg/L)

Executive summary:

The acute toxicity of the test item (= substance EC 939-457-4 in aqueous commercial product) to the freshwater crustacean species Daphnia magna was investigated in a GLP-compliant study performed in accordance with EU Method C.2 (Acute Toxicity for Daphnia). The 48-hour 50% effective concentration (mortality) of the test item was found to be 9.3 mg/L (corresponding to 4.6 mg solid content/L and 4 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:

supporting 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 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
C8-C18 AAPHS and C12-18 AAPHS have the same functional groups, and general composition. The main variable resides in the alkyl chain distribution.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical = C8-18 cocamidopropyl hydroxysultaine (EC 939-457-4).
Target chemical = C12-18 cocamidopropyl hydroxysultaine (EC 939-455-3).

3. ANALOGUE APPROACH JUSTIFICATION
Cf. attached Read-Across Justification Document (§13 Assessment reports).

4. DATA MATRIX
Cf. attached Read-Across Justification Document (§13 Assessment reports).

Reason / purpose for cross-reference:

read-across source

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

Remarks on result:

other: read-across from EC 939-455-3

Conclusions:

By analogy with the source substance EC 939-455-3, a 48h-EC50 (immobilization) of 6.62 mg solid content/L on the marine crustacean species Acartia tonsa was reported for the target substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-457-4).

Description of key information

The acute toxicity of the substance EC 939-457-4 to the freshwater crustacean species Daphnia magna was investigated in a GLP-compliant study (Bazin, 1994) performed in accordance with EU Method C.2 (Acute Toxicity for Daphnia). The 48-hour EC50 (mortality) of the substance was found to be 4.6 mg solid content/L based on nominal concentrations.

Besides, the acute toxicity of a structural analogue substance (= substance EC 939-455-3) to the marine crustacean species Acartia tonsa 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 analogue substance was found to be 6.62 mg solid content/L based on nominal concentrations. By analogy, the same EC50 value was reported for the target substance 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18(even numbered) acyl) derivs., hydroxides, inner salts (EC 939-457-4).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

4.6 mg/L

Additional information

The acute toxicity to freshwater invertebrate species of the substance EC 939-457-4 was investigated in a GLP-compliant study (Bazin, 1994) 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.

Besides, the acute toxicity to marine invertebrate species of the structural analogue substance 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 supporting study for the endpoint of the target substance EC 939-457-4.