Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24/04/2001- 30/07/2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No information provided.

Analytical monitoring:

yes

Details on sampling:

Water samples were collected from each test chamber at test initiation, at appoximately 48 hours and at test termination to measure concentrations of the test substance. Samples were collected from mid-depth of the test chambers. All samples were analyzed as soon as possible without storage.
Temperature, dissolved oxygen and pH were also measured in each test chamber daily during the test.

Vehicle:

not specified

Details on test solutions:

A 1.6 mg a.s./l primary stock solution was prepared by dissolving the test substance in reverse osmosis water. The primary stock solution was further diluted with reverse osmosis water to prepare four additional secondary stock solutions at concentrations of 8.0, 4.0, 2.0 and 1.0 mg a.s./l.
The working stock solutions were injected into the diluter mixing chambers at a rate of 0.0125 ml/minute, where they were mixed with dilution water at a rate of 125 ml/minute to achieve the desired test concentrations. The diluter was adjusted so that each test chamber received approximately 6 volume additions of test water every 24 hours.

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

Test organism: Bluegill (Lepomis macrochirus)
Source of test organisms: Osage Catfisheries Inc.
Age of test organisms: Juvenile
Fish acclimated to test conditions for approximately 50 hours prior to test initiation
Temperature: 21.9oC- 22.5oC
pH: 7.9-8.2
D.O. 8.0- 8.2 mg/l

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

The test animals were observed for 96 hours following the start of exposure.

Hardness:

128-132 mg/l CaCO3

Test temperature:

22 ± 2°C

pH:

7.9-8.2

Dissolved oxygen:

> 7.2 mg/l (*2% saturation)

Salinity:

No information provided.

Nominal and measured concentrations:

Nominal concentrations of the test substance: 0, 0.10, 0.20, 0.40, 0.80 and 1.6 mg a.s./l
Measured concentrations of the test substance: 0, 0.090, 0.19, 0.38, 0.77 and 1.4 mg a.s./l

Details on test conditions:

TEST SYSTEM
- Test vessel: 25l Teflon coated stainless steel aquaria

Effect parameter measured: Mortality.
Instantaneous loading: 0.72 g fish/l

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Test concentrations were doubled as they increased.
- Justification for using less concentrations than requested by guideline: No information provided.
- Test concentrations: Initial concentration of the test substance: 0, 0.10, 0.20, 0.40, 0.80 and 1.6 mg a.s./l
Actual concentrations of the test substance: 0, 0.090, 0.19, 0.38, 0.77 and 1.4 mg a.s./l
- Results used to determine the conditions for the definitive study: No information provided.

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

0.19 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.52 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits: 0.38 mg/L, 0.77mg/L

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

0.77 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

The results of this study indicate that Bardap 26 can be toxic to Bluegill over a 96hr period. The no-observed-effect concentration (NOEC) was calculated to be 0.19 mg a.s./l. The 96hr LC100 was found to be 0.77 mg a.s./l. The 96hr LC50 was calculated to be 0.52 mg a.s./l with 95% confidence limits of 0.38 mg a.s./l and 0.77 mg a.s./l. No behavioural abnormalities or other adverse effects were observed during the study.

Results with reference substance (positive control):

No information provided.

Reported statistics and error estimates:

No information provided.The data were analyzed using the computer program of C.E. Stephan. The 24, 48 and 96 hour LC50 values were calculated by binomial probability with nonlinear interpolation. The 72 hour LC50 was calculated by probit analysis. The NOEC was determined by visual interpretation of the mortality and clinical observation data.

Sublethal observations / clinical signs:

Table 1. Cumulative mortality

 

Nominal concentration (mg a.s./l)	Cumulative Mortality					% Mortality
	5 hours	24 hours	48 hours	72 hours	96 hours	96 hours
0	0	0	0	0	0	0
0.090	0	0	0	0	0	0
0.19	0	0	0	0	0	0
0.38	0	0	0	1	1	5
0.77	5	18	19	19	10	100
1.4	120	20	20	20	20	100

Validity criteria fulfilled:

yes

Conclusions:

Based on concentration effect relationship observed, the no-observed-effect concentration (NOEC) was found to be 0.19 mg/l under the conditions of this study, the LC50 to be 0.52 mg a.s./l and the LC100 to be 0.77 mg a.s./l.

Executive summary:

A 96-hour acute toxicity study was conducted to determine the ability of N,N-Didecyl-N-methylpoly(oxyethyl)ammonium Propionate (Bardap 26) to cause acute toxic effects to fish when tested in accordance with EPA OPPTS 850.1075. The test animals used were Bluegill (Lepomis macrochirus), exposed to the test material for 96 hours in a flow-through test system at concentrations of 0, 0.10, 0.20, 0.40, 0.80 and 1.6 mg a.s./l. (nominal concentrations: 0, 0.090, 0.19, 0.38, 0.77 and 1.4 mg a.s./l).

100% mortality was observed at the 0.77 and 1.4 mg a.s./L concentration groups and 5% mortality was recorded in the 0.38 mg a.s./L test group. No adverse effects were observed in any test group in the surviving fish. Based on concentration effect relationship observed, under the conditions of this study, the no-observed-effect concentration (NOEC) was found to be 0.19 mg/l.

Description of key information

A key study and a supporting study are provided for the assessment of short-term toxicity to fish.  Both studies are conducted in accordance with GLP, with no deviations from the guidelines. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

0.52 mg/L

Additional information

Study from which key value was derived:

A 96-hour acute toxicity study was conducted to determine the ability of N,N-Didecyl-N-methylpoly(oxyethyl)ammonium Propionate to cause acute toxic effects to fish when tested in accordance with EPA OPPTS 850.1075. The test animals used were Bluegill (Lepomis macrochirus), exposed to the test material for 96 hours in a flow-through test system at concentrations of 0, 0.10, 0.20, 0.40, 0.80 and 1.6 mg a.s./l. (nominal concentrations: 0, 0.090, 0.19, 0.38, 0.77 and 1.4 mg a.s./l).

100% mortality was observed at the 0.77 and 1.4 mg a.s./L concentration groups and 5% mortality was recorded in the 0.38 mg a.s./L test group. No adverse effects were observed in any test group in the surviving fish. Based on concentration effect relationship observed, under the conditions of this study, the no-observed-effect concentration (NOEC) was found to be 0.19 mg/l.

Supporting study:

The acute toxicity of Bardap 26 (N,N-Didecyl-N-methylpoly(oxyethyl)ammonium Propionate) was determined in a 96 hour semi-static study conducted on Common carp (Cyprinus carpio) conducted in accordance with EC Method C1 and OECD Guideline No. 203. Dechlorinated tap water, run through an activated carbon filter, and partially softened was used as dilution water. 20 litre glass exposure vessels were used for each test concentration. Test vessels were pre-conditioned with the test solutions and covered to reduce evaporation and maintained at 21°C with a photoperiod of 16-hours light and 8-hours darkness.

The test material was tested at concentrations of 0, 0.22, 0.39, 0.7, 1.26, 2.24 mg a.s./l and water samples were taken from the control and all surviving test groups were taken at 0, 24, 48 and 96 hours for quantitative analysis. Duplicate samples were taken and stored frozen for further analysis if necessary. Mortality was the test parameter. 100% mortality was observed at 1.26 mg a.s./l and 2.24 mg a.s./l concentrations, with 70% mortality observed at 0.7 mg a.s./l. The LC₅₀was determined to be 0.62 mg a.s./l, with the NOEC found to be 0.39 mg/L, based on the concentration effect relationship observed.