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 fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 13, 1996 (final report)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed according to an international guideline but not 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:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

no

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 : 100 mg/L carbon-filtered well water
- test concentrations : prepared by addition of the appropriate amont of stock solution
- Controls : no data
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No

Test organisms (species):

Pimephales promelas

Details on test organisms:

- Common name : Fathead minnow
- Strain : Pimephales promelas
- Source : Aquatic Biosystems, Inc., Fort Cllins, CO.
- Length at study initiation : 1.82 +/- 0.10 cm
- Weight at study initiation : 0.034 +/- 0.004 g
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD) : no data
- Weight at study initiation (mean and range, SD): no data
- Loading density (fish/litre) : 10 fish/beaker; 0.34 g/L
- Method of breeding: no data
- Feeding during test : no

ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions (same as test or not): no data
- Type and amount of food:TetraMin flake food
- Feeding frequency: daily until 72 hours before test initiation
- Feeding during the test : no
- Health during acclimation (any mortality observed): < 10% of the population in 7 days prior to test initiation

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

270 mg/L as CaCO3 (dilution water)
280 mg/L as CaCO3 (concentration of 5.0 mg/L)

Test temperature:

18.7 - 19.0°C (definitive test)

pH:

From 7.8 to 8.2 (test solutions) (definitive test)
7.5 (dilution water)

Dissolved oxygen:

From 71% to 87% of the air saturation value (definitive test)

Nominal and measured concentrations:

Nominal concetrations : 1.0, 2.5, 5.0, 7.5, 10.0 mg/L for the definitive test
Note : a range-finding test was performed previously to determine the concentration for use in the definitive test.

Details on test conditions:

TEST SYSTEM
Test vessel:
- Type (delete if not applicable): no data (open/closed)
- Material, size, headspace, fill volume: 1200 mL polypropylene beakers
- Test volume : 1000 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): -
- Renewal rate of test solution (frequency/flow rate): -
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): -
- Biomass loading rate: 0.34 g/L

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Carbon-filtered well water. 3M Well No.2, St. Paul, MN
- Treatment process : Water aerated 24-hours prior to test initiation. Well water (100%) was used for culturing the fish.
- Total organic carbon: 3.4 mg/L
- Total dissolved solids : 280 mg/L
- Total solids : 470 mg/L
- Total suspended solids : < 2 mg/L
- Metals: no data
- Pesticides: no data
- Total residual chlorine: < 0.02 mg/L
- Alkalinity: 250 mg/L
- Ca/mg ratio: no data
- Conductivity: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hrs light; 8-hrs dark
- Lighting : Cool-white fluorecent light

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4.87 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits: 3.92 - 6.06 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.12 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

Percent mortality values obtained after 24, 48, 72 and 96 hours of exposure to MIRATAINE CBS are summarized in table 1.
In duplicated measurements, the median lethal concentration (96-hour LC50) for MIRATAINE CBS was reported as 4.87 mg/L. The 95% confidence interval were 3.92 to 6.06 mg/L. The NOEC is < 0.1 mg/L. The LOEC is 1.0 mg/L.

Reported statistics and error estimates:

The reported values were based on nominal concentrations in the test media at the beginning of the test.
A total of 20 fish were exposed to each concentration. The concentrations tested and the corresponding response data derived from the duplicated toxicity test used to calculate, if possible, the median lethal concentration, LC50 and the 95% confidence interval by standard logistic regression methods (i.e., Probit Analysis, Trimmed Spearman-Karber).
The LC50 is defined as the concentration estimated to kill 50 percent of the fish after 96 hours exposure. The NOEC (No observed Effect Concentration) and LOEC (Lowest Observed Effect Concentration) are also determinated from the data.

Sublethal observations / clinical signs:

Table 1 -Percent mortality during the exposure period

PERCENT MORTALITY (%)
Test concentrations mg/L *	24-hrs	48-hrs	72-hrs	96-hrs
Blank control 1	0	0	0	0
Blank control (duplicate)	0	0	0	0
1 mg/L	0	10	20	20
1 mg/L (duplicate)	0	10	10	20
2.5 mg/L	0	10	10	20
2.5 mg/L (duplicate)	0	10	20	20
5 mg/L	0	30	30	40
5 mg/L (duplicate)	0	30	40	40
7.5 mg/L	100	100	100	100
7.5 mg/L (duplicate)	100	100	100	100
10.0 mg/L	100	100	100	100
10.0 mg/L (duplicate)	100	100	100	100

- 10 fish per replicate. A total of 20 fish were exposed per concentration

Validity criteria fulfilled:

yes

Remarks:

Not more than 10% of the control fish were dead / The Dissolved Oxygen Cocentrations were greater than 60% of the air saturation value at the temperature tested at the end of the test / Test temperature did not vary more than 1°C in any 24-hour period

Conclusions:

In duplicated measurements, the 96-hour 50% lethal concentration LC50 of the test item was reported as 4.87 mg/L (corresponding to 2.12 mg active ingredient/L).

Executive summary:

The acute toxicity of 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) to the freshwater fish species Pimephales promelas (fathead minnow) was investigated in a GLP-compliant study performed in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). The 96-hour 50% lethal concentration LC50 of the test item was found to be 4.87 mg/L (corresponding to 2.12 mg active content/L) based on nominal concentrations.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

30 may 1996 - 29 october 1996

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:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method : for each tested concentration, the test item was introduced in a single dose in the aquarium and then dissolved in the 50 liters of dechlorinated drinking water
- Stock solution : no
- Controls :dilution water (circulated, filtered and cooled water) without of addition of the test item
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain:Brachydanio rerio
- Source : MERIDIANA AQUARIUM, S.A., Avda. Mridiana, 297, 08027 - BARCELONA (Spain)
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD) : no data. Just indicated the lengh of the fish at the end of the study :between 3.0 and 3.4 cm
- Weight at study initiation (mean and range, SD): no data
- Method of breeding: no data
- Feeding during test : no


ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: TERAMIN supplied by Tetraverke
- Feeding frequency: twice daily, until 24 hours before the start of the test
- Health during acclimation (any mortality observed): two days after the quarantine period, animal mortality started to be recorded. This register was kept until day 9 of that period. None of the fish died

QUARANTINE (wild caught)
- Duration: 12-day period
- Health/mortality: none of the fish died

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

No data

Test temperature:

20.1-24.2
See table 1 below

pH:

8.24-8.444
See table 2 below

Dissolved oxygen:

65-91
See table 3 below

Nominal and measured concentrations:

Nominal concentrations :
Preliminary study : 100-50-25-12.5-6.25 mg/L
Main study : 12.5-8.84-6.25-3.12 mg/L

Details on test conditions:

TEST SYSTEM
Test vessel:
- Type (delete if not applicable): no data (open/closed)
- Material, size, headspace, fill volume: glass aquarium with a maximum capacity of 84 l and measuring 70 x 30 x 40 cm
- Aeration: no data
- Type of flow-through (e.g. peristaltic or proportional diluter): -
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5 (preliminary study) and 10 (main study)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2 (preliminary study) and 1 (main study)
- No. of vessels per vehicle control (replicates): -
- Biomass loading rate: -

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:dechlorinaed drinking water
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity: no data
- Ca/mg ratio: preliminary study 213.6-231.4 mg/L (in CaCO3) / main study 195.8-231.4 mg/L (in CaCO3)
- Conductivity: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h photoperiod/8h dark, daily
- Light intensity: no data

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

6.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits = 5.12-7.96 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.66 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

3.12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.29 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Observations on body length and weight: no data
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: -

Results with reference substance (positive control):

No reference used

Reported statistics and error estimates:

The percentages of mortality were recorded for each concentration (see table 4)
The LC50 and its limits of confidence were estimated at 95% using the method of Litchfield and Wilcoxon.

Sublethal observations / clinical signs:

Table 1 : temperature (°C)

Test Group	Measuring (Day)
	0.	24h	48h	72h	96h
Control	21.8	23.9	22.9	24.4	24.2
12.5 mg/L	21.7	-	-	-	-
6.25mg/L	22.6	20.6	22.8	22.8	23.0
3.12mg/L	20.5	20.7	20.6	20.7	20.1
8.84 mg/L	20.7	-	-	-	-
8.84 mg/L	23.0	23.1	23.2	23.3	23.3

Table 2 : pH

Test Group	Measuring (Day)
	0.	24h	48h	72h	96h
Control	8.38	8.35	8.44	8.43	8.41
12.5 mg/L	8.30	-	-	-	-
6.25mg/L	8.23	8.31	8.30	8.33	8.36
3.12mg/L	8.29	8.26	8.25	8.30	8.34
8.84 mg/L	8.24	-	-	-	-
8.84 mg/L	8.28	8.30	8.36	8.36	8.39

Table 3 : Dissolved oxygen (%)

Test Group	Measuring (Day)
	0.	24h	48h	72h	96h
Control	75	71	68	73	69
12.5 mg/L	65	-	-	-	-
6.25 mg/L	81	82	82	83	86
3.12 mg/L	90	91	84	88	93
8.84 mg/L	82	-	-	-	-
8.84 mg/L	80	83	89	89	91

Validity criteria fulfilled:

yes

Remarks:

See "Rationale for reliability incl. deficienties".

Conclusions:

No mortality were observed in the control up the end of the test. No mortality was observed up to 3.12 mg/l and 100% mortality was observed at 12.5 mg/L at the end of the test.

Executive summary:

The acute toxicity of the test item (= substance EC 939-455-3 in aqueous commercial product) to the freshwater fish species Brachydanio rerio was investigated in a GLP-compliant study performed in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). The 96-hour 50% lethal concentration LC50 of the test item was found to be 6.4 mg/L (corresponding to 2.66 mg active content/L) based on nominal concentrations.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

january 2009 - 24 march 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: OSPARCOM (1995) (amended March 2005) - Protocol for a fish acute toxicity test

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method : The test item is caracterized as soluble in water and therefore was added to the test system directly via seawater.
- Stock solution : no
- Controls : no data
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No

Test organisms (species):

other: marine fish : Scophthalmus maximus

Details on test organisms:

- Common name : Juvenile turbot
- Strain : Scophthalmus mawimus
- Source : Ardtoe Hatchery
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD) : no data
- Weight at study initiation (mean and range, SD): no data
- Loading density (fish/litre) : 0.878
- Method of breeding: no data
- Feeding during test : no


ACCLIMATION
- Acclimation period: 24 days
- Acclimation conditions (same as test or not): Scophthalmus mawimus were held under flow-through conditions in 200 litre capacity polythene tanks, containing 1 µm filtered ultra-violet treated seawater and supplied with gentle aeration
- Type and amount of food: fed food in pellet form ad libitum
- Feeding frequency: twice daily
- Health during acclimation (any mortality observed): 0% mortality

Test type:

semi-static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

no data

Test temperature:

14.2 - 15.4

pH:

7.67 - 7.99

Dissolved oxygen:

91 - 98

Salinity:

36 - 38

Nominal and measured concentrations:

At 0 hour (beginning of the test) : 0.01245 g of test item is diluted to 23000 ml of treated seawater in order to to obtain a nominal concentration of 0.54 mg/l
At 48 hours (replacement of media) : 0.01242 g of test item is diluted to 23000 ml of treated seawater in order to to obtain a nominal concentration of 0.54 mg/l

Details on test conditions:

TEST SYSTEM
Test vessel:
- Type (delete if not applicable): no data (open/closed)
- Material, size, headspace, fill volume: 30 litre capacity moulded soda-lime glass tanks
- Aeration: gentle aeration
- Type of flow-through (e.g. peristaltic or proportional diluter): -
- Renewal rate of test solution (frequency/flow rate): at 48h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): -
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: natural local seawater pumped to holding tanks from Scapa Flow, Orkney
- Treatment process : sand filtered to remove particulate, filtered to 1 µm, heated to 16°C, UV treated, degassed and held at a quantity of 3000 to 5000 litres.
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity: no data
- Ca/mg ratio: no data
- Conductivity: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: constant illumination
- Light intensity: no data

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.54 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.27 mg/L

Nominal / measured:

nominal

Conc. based on:

other: solid content

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.23 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Observations on body length and weight: measured at the end of the test (see table 2 above)
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: -

Validity criteria fulfilled:

yes

Remarks:

See "Rationale for reliability incl. deficienties"

Conclusions:

No mortality was observed in the control and at the tested concentration of 0.54 mg/L. Thus, the 96-hour LC50 of the test item was calculated to be >0.54 mg/L (>0.27 mg solid content/L).

Executive summary:

The acute toxicity of the test item (= substance EC 939-455-3 in aqueous commercial product) to the marine fish species Scophthalmus maximus was investigated in a GLP-compliant study performed in accordance with OSPARCOM guidelines (Protocol for a fish acute toxicity test). In a limit test, the 96-hour 50% lethal concentration LC50 of the test item was found to be >0.54 mg/L (corresponding to >0.27 mg solid content/L and >0.23 mg active content/L) based on nominal concentrations.

Reference 4

Endpoint:

short-term toxicity to fish

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 939-455-3).
Target chemical = C12-18 cocamidopropyl hydroxysultaine (EC 939-457-4).

3. ANALOGUE APPROACH JUSTIFICATION
The alkyl C-chain distribution of the source chemical significantly overlaps with the one of the target chemical, the C12-alkyl derivative being the major constituent in both chemicals. The structural differences in side C-chains is not expected to lead to significant differences on phys-chem properties.

4. DATA MATRIX
See "Documentation and scientific justification of the read-across approach" in section 13.2.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.66 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

as a 96-hour LC50 expressed in solid content was not reported, the 96-hour LC50 expressed in active content was used as a worst-case for the assessment

Basis for effect:

mortality (fish)

Remarks on result:

other: Brachydanio rerio (freshwater sp.)

Remarks:

read-across from EC 939-455-3

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.27 mg/L

Nominal / measured:

nominal

Conc. based on:

other: solid content

Basis for effect:

mortality (fish)

Remarks on result:

other: Scophthalmus maximus (marine sp.)

Remarks:

read-across from EC 939-455-3

Conclusions:

By analogy with the source substance EC 939-455-3, a 96h-LC50 of 2.66 mg solid content/L on the freshwater fish species Brachydanio rerio 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). In addition, by analogy with the source substance EC 939-455-3, a 96h-LC50 of >0.23 mg solid content/L on the marine fish species Scophthalmus maximus was reported for the target substance.

Description of key information

The acute toxicity of the 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) to the freshwater fish Pimephales promelas (fatheat minnow) was investigated in a GLP-compliant study (Robideau, 1996) performed in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). The 96-hour LC50 of the substance was found to be 2.12 mg active content/L based on nominal concentrations. As a 96-hour LC50 expressed in solid content was not reported, the 96-hour LC50 expressed in active content was used as a worst-case for the assessment.

The acute toxicity to the fish species Brachydanio rerio (freshwater sp.) and Pimephales promelas (marine sp.) of a structural analogue substance (= source substance EC 939-455-3) was otherwise investigated in two GLP-compliant studies (Mayordomo, 1996; Richardson, 2009) performed in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test) and with OSPARCOM guidelines (Protocol for a fish acute toxicity test), respectively. The 96-hour LC50 to B. rerio of the analogue substance was found to be 2.66 mg active content/L based on nominal concentrations; as a 96-hour LC50 expressed in solid content was not reported, the 96-hour LC50 expressed in active content was used as a worst-case for the assessment. Besides, the 96-hour LC50 to S. maximus of the analogue substance was found to be >0.27 mg solid content/L based on nominal concentrations. By analogy, the same LC50 values were 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 fish

Fresh water fish

Effect concentration:

2.12 mg/L

Additional information

The acute toxicity to fish of the substance EC 939-457-4 was investigated in a GLP-compliant study (Robideau, 1996) performed in accordance with standard methods, without deviations. As there was no analytical monitoring of actual test concentrations, the study is considered as reliable with restrictions (Klimisch 2) and was selected as key study for the endpoint.

Besides, the acute toxicity to fish of the structural analogue EC 939-455-3 was investigated in two GLP-compliant studies (Mayordomo, 1996; Richardson, 2009) performed in accordance with standard methods, without deviations. As there was no analytical monitoring of actual test concentrations, the studies are considered as reliable with restrictions (Klimisch 2) and were selected as supporting studies for the endpoint of the target substance EC 939-457-4.