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 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:

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

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 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 2

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

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 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 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

10 february 1995 - 3 july 1995

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Too much lack of data : - information related to the test organisms (acclimatation,feeding period and frequency, body length at the study initiation, loading in the test) - no information related to the test media - test concentrations : 4 test concentrations (the guideline indicate to test at least five centrations) -no indication concerning the number of replicates

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

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 g of the test substance was added to drinking water (end-volume 1000 mL). Tis solution was then stirred for 30 minutes on the magnetic stirrer and the corresponding volumes from this were dosed using a pipette.
- 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):

Danio rerio (previous name: Brachydanio rerio)

Sublethal observations / clinical signs:

In the control and at the test concentrations up to and including 2 mg/L, all fish survived until the end of the test

At the test concentration of 4 mg/L, all the fish died during the first 48 hours.Thus, the 96-hour NOEC of the test item to zebra fish was determined to be 2 mg/L. The 96-hour LC50 of the test item was calculated to be 2.8 mg/L. The 96-hour LC100 was determinated to be 4 mg/L.

Validity criteria fulfilled:

not specified

Remarks:

according to the report, the validity criteria fulfilled but not enough details to be sure of this.

Conclusions:

The 96-hour LC50 of the test item was calculated to be 2.8 mg/L.

Executive summary:

The acute toxicity of the test item to the freshwater fish 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 2.8 mg/L based on nominal concentrations.

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

- lack of information on test organisms and test conditions (acclimatation, feeding period and frequency, body length at the study initiation, loading in the test);

- no information related to the test media;

- test concentrations : 4 test concentrations (the guideline indicates to test at least five centrations);

- no indication concerning the number of replicates.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

- No characterization of the test item - No data concerning the physical measurements (pH, dissolved oxygen, temperature, salinity values). One of the validity criteria failed : dissolved oxygen concentration that must have been at least 60% of the air saturation value throughout the test) - Lack of information concerning the test organisms (lengh, loading, feeding)

Qualifier:

according to guideline

Guideline:

other: OSPARCOM (1995) (amended March 2005) - Protocol for a fish acute toxicity test

Deviations:

yes

GLP compliance:

yes

Analytical monitoring:

not specified

Vehicle:

not specified

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTIONS
- Method : one concentration of the test item was tested : 2.03 mg/L in artificial seawater
- Stock solution : no
- Controls : no data
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No data

Test organisms (species):

other: marine fish : Scophthalmus maximus

Details on test organisms:

- Common name : Juvenile turbot
- Strain : Scophthalmus mawimus
- Source : held in artificial seawater. Supplier : France Turbot, l'Epine - France
- 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) : no data
- Method of breeding: no data
- Feeding during test : no


ACCLIMATION
- Acclimation period: yes
- Acclimation conditions (same as test or not): Stock juvenile turbot were held in artificial seawater maintained at 15 +/-2°C by a chiller unit and aerated via air diffusers attached to the laboratory air supply system.
- Type and amount of food: no data
- Feeding frequency: no dat concerning the frequency. Just one information : feeding was stopped when juvenile turbot were transferred to test tanks before the sart of the test.
- Health during acclimation (any mortality observed): no data

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

no data

pH:

no data

Dissolved oxygen:

no data

Nominal and measured concentrations:

A nominal concentration of test item was prepared in artificial seawater in order to obtain 2.03 mg/L

Details on test conditions:

TEST SYSTEM
Test vessel:
- Type (delete if not applicable): no data (open/closed)
- Material, size, headspace, fill volume:no data
- Aeration: no data
- 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 (each vessel contained 7 juvenile turbot in 10 L volumes or control media.
- No. of vessels per concentration (replicates): no data
- No. of vessels per control (replicates): no data
- No. of vessels per vehicle control (replicates): -
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: artificial seawater (Coral reef, Kent Sea Salt, red Sea Fish Pharm)
- Treatment process : no data
- 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: no data
- Light intensity: no data

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

2.03 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

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

Validity criteria fulfilled:

no

Remarks:

No indication concerning the dissolved oxygen concentration (validity criteria : at least 60% of the air saturation value throughout the test

Conclusions:

One mortality was observed in the control at 48hours.
No mortality was observed at the tested concentration of 2.03 mg/L
Thus, the 96-hour LC50 of the test item was calculated to be > 2.03 mg/l

Executive summary:

The acute toxicity of the test item to the marine fish Scophthalmus maximus was investigated in a GLP-compliant study performed in accordance with OSPARCOM guidelines (Protocol for a fish acute toxicity test). The 96-hour 50% lethal concentration LC50 of the test item was found to be >2.03 mg/L.

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

- no characterization of the test item;

- lake of information concerning the test organisms (lengh, loading, feeding);

- no data concerning the physical measurements (pH, dissolved oxygen, temperature, salinity values);

- one of the validity criteria failed : dissolved oxygen concentration that must have been at least 60% of the air saturation value throughout the test.

Description of key information

The acute toxicity to the fish species Brachydanio rerio (freshwater sp.) and Scophthalmus maximus (seawater sp.) 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 two GLP-compliant studies (Mayordomo, 1996; Richardson, 2009) performed in accordance with standard methods. The results led to the following conclusions:

- Brachydanio rerio (freshwater): the substance exhibited a 96-hour LC50 of 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);

- Scophthalmus maximus (seawater): the test item exhibited a 96-hour LC50 of >0.27 mg solid content/L based on nominal concentrations (limit test).

The acute toxicity to fish was otherwise investigated in two other studies (Schultz, 1995; Hill, 2006) which were not considered in the assessment due to major methodological deficiencies and insufficient documentation.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

2.66 mg/L

Additional information

The acute toxicity to freshwater and marine fish 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 two GLP-compliant studies (Mayordomo, 1996; Richardson, 2009) performed in accordance with standard methods, without deviations. Both studies are considered as reliable with restrictions (Klimisch 2) and were selected as key studies for the endpoint. The two other available studies (Schultz, 1995; Hill, 2006) are considered as not reliable (Klimisch 3) and were disregarded for the endpoint.