Imidazolium compounds, 2-C17-unsatd.-alkyl-1-(2-C18-unsatd. amidoethyl)-4,5-dihydro-N-methyl, Me sulfates

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was performed according to accepted scientifical standards. However there minor deviation from the guideline, but this does not invalidate the study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1981

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Salmo-Gardia, Shasta
- Source: Fischzucht Jochen Müller, 30966 (formerly 3005) Harkenbleck, Germany
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 5 - 6 cm ("Setzlinge")
- Method of breeding: Fish were kept for 14 days in a 360 L basin prior acclimation, water removal at a flow rate of 80L/hour, aeration, advection of the water, removal of suspendend matter, O2-content was > 90% saturation.
- Feeding during test: no

ACCLIMATION
- Acclimation period: An appropriate number of fish were kept for two days in a 240 L basin
- Acclimation conditions (same as test or not): yes

Test type:

not specified

Water media type:

freshwater

Test temperature:

16 +/- 1 degreeC

pH:

7.3 +/- 0.13

Dissolved oxygen:

7.8 - 8.0

Nominal and measured concentrations:

10.0, 13.3, 17.6, 23.3, 30.8 mg test mat. /L (nominal), no control was perfomed

Details on test conditions:

TEST SYSTEM
- Test vessel: 30 L glass aquaria
- Aeration: yes
- Renewal rate of test solution: no data
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
-No controls were performed


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water for human use, Stadtwerke Hannover

- Metals: Ca2+: 1.140 mmol/L +/- 5%, Mg2+: 0.610 mmol/L +/- 5 %
- Acid capacity up to pH 4.3: 1.65 - 1.45 mval/L
-Base capacity up to pH 8.2: 1.8 mg/L
- Ca/mg ratio:1.14:0.61
- Culture medium different from test medium: No
- Intervals of water quality measurement: O2-monitoring daily


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: No data


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality


TEST CONCENTRATIONS
- Range finding study
- Test concentrations: Yes
- Results used to determine the conditions for the definitive study: No data

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 9.84 - <= 10.24 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: Confidence interval: 2.7 - 11.73 mg a.i./L

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 11.4 - <= 11.86 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: Confidence interval: 9.38 - 13.40 mg a.i./L

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

13.91 - 14.48 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: Confidence interval: 12.00 - 17.39 mg a.i./L

Details on results:

Effect concentrations:

96 h LC50 = 13.3 mg test mat./L (nominal, Confidence interval: 3.69 - 15.24 mg/L )
48 h LC50 = 15.4 mg test mat./L (nominal, Confidence interval: 12.67 - 17.40 mg/L)
24 h LC50 = 18.8 mg test mat./L (nominal, Confidence interval: 16.22 - 22.59 mg/L)
96 h LC50 = 9.84 – 10.24 mg act. ingr./L (nominal, Confidence interval: 2.7 - 11.73 mg/L)
48 h LC50 = 11.40 – 11.86 mg act. ingr./L (nominal, Confidence interval: 9.38 - 13.40 mg/L)
24 h LC50 = 13.91 – 14.48 mg act. ingr./L (nominal, Confidence interval: 12.00 - 17.39 mg/L)

- Behavioural abnormalities: At test start fisch showed enhanced activity and prospecting the new surrounding, however no adverse effects were observed.
- Observations on body length and weight: No
- Other biological observations: The dead animals showed apparently no alternation in appearence, pigmentation, mucosa and eyes .
- Mortality of control: No control
- Abnormal responses:
- Any observations that might cause a difference between measured and nominal values: In a seperate test analytical monitoring (UV spectrometric measurement) of the a.i. in aqueous solution showed depletion of the a.i. ( 0.0504 mg/L at time 0, 0.0468 mg/L afetr 48 hours, and 445 mg/L after 96 hours).

No control was performed.

Reported statistics and error estimates:

LC50 was calculated according to Probit analysis after Finney (1971)
Since no control was performed, it is assumed that the lowest test concentration without any adverse affects on fish was taken as control for statistical analysis. This is acceptable, since the concentration/response curve is very steep.

Sublethal observations / clinical signs:

Mortality of Rainbow trout (Onchorhynchus mykiss) during a 96-Hour Exposure to test substance under Static Test Conditions

Concentrations (nominal) [ppm]	Concentrations (nominal) [mg test mat. /L]	Cumulative number	Mortality [%]	Cumulative number	Mortality [%]	Cumulative number	Mortality [%]
		24 hours	24 hours	48 hours	48 hours	96 hours	96 hours
10.0	300	0	0	0	0	0	0
13.3	399	1	10	3	30	5	50
17.6	528	6	60	8	80	10	100
23.3	699	7	70	9	90	10	100
30.8	924	9	90	10	100	10	100

The test substance forms stable suspensions in water. All test concentrations were below the suspensibility of the test material.

No control was performed.

Validity criteria fulfilled:

no

Remarks:

no control was performed

Conclusions:

There is minor deviation from the OECD-Test Guideline 203 ( no control was performed). For statistical analysis the lowest concentration with no adverse effects to fish was presumably used, however this is acceptable, since the concentration/response curve is very steep.
The test material partially unsaturated IQAC, DMS quaternised contains considerable amounts of isopropanol. The toxicity of isopropanol against fish is about 100 to 1000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.
Despite of this the study is performed according to acceptable scientifical standards and regarded as reliable with restrictions

Executive summary:

In a 96-h acute toxicity study, Rainbow trouts (Salmo-Gardia, Shasta, Oncorhynchus mykiss) were exposed to partially unsaturated IQAC, DMS quaternised at nominal concentrations of 10.0, 13.3, 17.6, 23.3, 30.8 mg test mat. /L.  The 96-h LC50 was 9.84 – 10.24 mg act. ingr./L (nominal, Confidence interval: 2.7 - 11.73 mg a.i./L) .  Sublethal effects were not observed. The observed concentration/response curve is very steep. The test material contains considerable amounts of isopropanol. The toxicity of isopropanol against fish is about 100 to 1000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.
This toxicity study is classified as acceptable with restrictions and satisfies the guideline requirement for acute toxicity to fish despite of some deviations that do not invalidate the study.

 

Results Synopsis

Test organism size/age: juvenile rainbow trout (Onchorhynchus mykiss)
Test Type: no data, OECD 203

LC50:  9.84 – 10.24 mg a.i./L                        95% C.I.:  2.7 to 11.73 mg a.i./L

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

96 h

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No data on analytical purity of the test substance is available. No analytical monitoring was conducted.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Length at study initiation (length definition, mean, range and SD): 47 - 65 mm (average 54.8 mm)
- Weight at study initiation (mean and range, SD): 1.45 - 3.84 g (average 2.32 g)

ACCLIMATION
- Acclimation period: 2 weeks, then held at test temperature for 5 days
- No mortalities during the 5 day period.

Test type:

semi-static

Limit test:

no

Total exposure duration:

96 h

Hardness:

mean: 54 mg/l CaCO3 (49 - 60 mg /l CaCO3)

Test temperature:

22°C (+-1°C)

pH:

7.2 - 8.5

Dissolved oxygen:

6.6 - 8.4 mg/l

Nominal and measured concentrations:

0.32; 1.0; 1.8; 3.2; 5.6 mg/l + freshwater control (nominal concentrations)
0.24, 0.75, 1.35, 2.4, 4.2 mg/l based on a. i. (mean 75%)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Aeration: continously
- glas aquaria (39 x 28 x 28 cm), 28 l volume
- test volume: 20 l
- Renewal rate of test solution: 24h interval
- No. of organisms per vessel: 10 fish per concentration and control
- continuous aeration


TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: 24h interval


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- mortality was recorded in test solutions and control

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 2.4 mg/L (nominal); 99.8% CL: 1.8 - 3.2

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

1.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 2.4 mg/L (nominal); 99.8% CL: 1.8 - 3.2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

1.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 2.4 mg/L (nominal); 99.8% CL: 1.8 - 3.2

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

2.6 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 2.4 mg/L (nominal); 95% CI: 2.9 - 4.4

Details on results:

- 96h-LC50 = 1.8 mg/l (based on a.i. content of 75%)
- Mortality of control: 0%

Sublethal observations / clinical signs:

Percent mortality observed:

Nominal concentration of test substance [mg/l]	24 h	48 h	72 h	96 h
5.6	100	100	100	100
3.2	30	100	100	100
1.8	0	0	0	0
1.0	0	0	0	0
0.32	0	0	0	0
control	0	0	0	0

Validity criteria fulfilled:

yes

Remarks:

Valid with restriction. No data on analytical purity of the test substance is available. No analytical monitoring was conducted. Therefore the test concentrations can only be based on nominal concentrations of the test material.

Conclusions:

In a 96-h acute toxicity study, Leuciscus idus were exposed to oleic acid-based IQAC, DMS quaternised at nominal concentrations of 0 (control), 0.32; 1.0; 1.8; 3.2; 5.6 mg/l under semi-static conditions. The 96-h LC50was 1.8 mg a.i. /L (2.4 mg/l, nominal).

Executive summary:

In a 96-h acute toxicity study, Leuciscus idus were exposed to oleic-acid based IQAC, DMS quaternised at nominal concentrations of 0 (control), 0.32; 1.0; 1.8; 3.2; 5.6 mg/l under semi-static conditions. The 96-h LC50was 1.8 mg a.i. /L (2.4 mg/l, nominal).

This study is classified as reliable with restriction and satisfies the guideline requirements for an acute toxicity study with fish.

Results Synopsis
Test organism size: 47 - 65 mm (average 54.8 mm)
Test organism size: 1.45 - 3.84 g (average 2.32 g)
Test Type: Static Renewal

LC50: 2.4 mg/l (nominal, 99.8% C.I.: 1.8 to 3.2 mg/l)

LC50 = 1.8 mg a.i. /l (based on a.i. content of 75%)
Endpoint(s) Effected: mortality

Description of key information

The 96-h LC50 was 1.8 mg/l (based on a.i. content of 75%; 2.4 mg/L nominal)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

1.8 mg/L

Additional information

In a 96-h acute toxicity study, Leuciscus idus were exposed to Oleic-acid based IQAC, DMS quaternised under semi-static conditions. The 96-h LC50was 1.8 mg/l (based on a. i. content of 75%; 2.4 mg/l (nominal)).