Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C11-17 and C17 unsatd. alkyl) derivs. and sodium hydroxide and 2-propenoic acid

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:

weight of evidence

Study period:

October 29, 2001 - December 7, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

yes

Details on sampling:

- The samples that are taken for analysis: From the first experiment: testvessels with the concentrations: 25; 40 and 63 mg/L
at t=0 and at t=24h
- Sampling method: TOC measurement; of the old and new test solution

Vehicle:

no

Details on test solutions:

A stock solution containing 100,3 mg/l in deionized water was prepared. Its TOC was determined. The TOC was 19,05 mg/L, corresponding to a carbon content of 19%. On each day of the pre-test, a stock solution containing 1000 mg/l in drinking water was prepared. The stock solution then was used to prepare solutions of the concentrations to be tested. On each day of the main study, a stock solution containing 10.000 mg/l in drinking water was prepared. The stock solution then was used to prepare solutions of the concentrations to be tested.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Strain: Hamilton Buchanan
- Source: UBA, Berlin (second generation offspring)
- Age at study initiation (mean and range, SD): approx. 4 months
- Length at study initiation (length definition, mean, range and SD): 2 +/- 1 cm

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: warm water fish food, daphnia, artemisia, tubifex or ground liver
- Feeding frequency: 3 times daily
- Health during acclimation (any mortality observed): < 5%

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Not applicable

Hardness:

Not reported

Test temperature:

23 +/- 2 degrees Celsius

pH:

7,9 - 8,2 (measured)

Dissolved oxygen:

Stayed above 7 mg/l throughout the test

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 0, 16, 19, 22, 25, 40 and 63 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria (10 liter)
- Aeration: yes, 1/s
- Renewal rate of test solution (frequency/flow rate): 1/24 h
- No. of organisms per vessel (pre-test): 3
- No. of organisms per vessel (main test): 7

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12 hours

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

19 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

7.4 mg/L

Nominal / measured:

nominal

Conc. based on:

other: expressed as solid content

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

21.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 19 - 25 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.5 mg/L

Nominal / measured:

nominal

Conc. based on:

other: expressed as solid content

Basis for effect:

mortality (fish)

Remarks on result:

other: 7.4-9.8

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

9.8 mg/L

Nominal / measured:

nominal

Conc. based on:

other: expressed as solid content

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

Not applicable

Sublethal observations / clinical signs:

Mortalities in the pre-test:

Conc. (mg/L)	Total of fish used	Dead fish; t=24h		Dead fish; t=48h		Dead fish; t=72h		Dead fish; t=96h
		actual	cumul.	actual	cumul.	actual	cumul.	actual	cumul.
Blank	3	0	0	0	0	0	0	0	0
1	3	0	0	0	0	0	0	0	0
10	3	0	0	0	0	0	0	0	0
100	3	3	3	0	3	0	3	0	3

 

Mortalities in the main test:

Conc. (mg/L)	Total of fish used	Dead fish; t=24h		Dead fish; t=48h		Dead fish; t=72h		Dead fish; t=96h
		actual	cumul.	actual	cumul.	actual	cumul.	actual	cumul.
Blank (1^stexperiment)	7	0	0	0	0	0	0	0	0
Blank (2^ndexperiment)	7	0	0	0	0	0	0	0	0
16 (1^stexperiment)	7	0	0	0	0	1	1	0	1
19 (2^ndexperiment)	7	0	0	0	0	0	0	0	0
22 (2^ndexperiment)	7	0	0	0	0	4	4	2	6
25 (1^stexperiment)	7	7	7	-	7	-	7	-	7
40 (1^stexperiment)	7	7	7	-	7	-	7	-	7
63 (1^stexperiment)	7	7	7	-	7	-	7	-	7

 

Determined TOC-concentrations:

Stock solution (100,3 mg/l): 19,05 mg/L

Nominal conc. Mg/L	TOC-concentration in mg/L (old/new test solution)
	0h	24h		48h		72h		96h
	new	old	new	old	new	old	new	old
Blank	0	0.02	-	-	-	-	-	-
25	2.49	8.03	-	-	-	-	-	-
40	4.40	4.94	-	-	-	-	-	-
63	9.64	3.17	-	-	-	-	-	-
100*	15.40	20.29	-	-	-	-	-	-

 *This solution was aerated for 24 hours and then the TOC was measured.

Validity criteria fulfilled:

yes

Remarks:

(no mortalities occurred in the controls; concentration of dissolved oxygen stayed above 7 mg/L or 81% throughout the test)

Conclusions:

96h-LC50: 21.8 mg/L (based on test material)
96h-LC50: 8.5 mg/L (based on solid content)

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

December 12, 1994 - January 13, 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no analytical monitoring

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

Cited as Directive 92/69/EEC, C.1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

no

Details on sampling:

Not applicable

Vehicle:

no

Details on test solutions:

See section Any other information on materials and methods.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

See section Any other information on materials and methods

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Not applicable

Hardness:

180 to 208 ppm as CaCO3

Test temperature:

14.7 to 15.4°C (definitive test)

pH:

7.8 to 8.5

Dissolved oxygen:

61 to 95% of saturation

Salinity:

Not applicable

Nominal and measured concentrations:

See section Any other information on materials and methods

Details on test conditions:

See section Any other information on materials and methods

Reference substance (positive control):

yes

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

7.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

3 mg/L

Nominal / measured:

nominal

Conc. based on:

other: expressed as solid content

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

10.6 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.:

4.2 mg/L

Nominal / measured:

nominal

Conc. based on:

other: expressed as solid content

Basis for effect:

mortality (fish)

Remarks on result:

other: 3 - 6 mg/L

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

15.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

6 mg/L

Nominal / measured:

nominal

Conc. based on:

other: expressed as solid content

Basis for effect:

mortality (fish)

Details on results:

Validity criteria fulfilled: yes (0% mortality in the control).

Results with reference substance (positive control):

Lindane: CL50-24 h: 0.055 ppm (w/w) (nominal concentration) - 95% confidence interval: 0.027-0.068 mg/l (calculated with the binomial method). The data are in conformity with the historical data of the laboratory.

Reported statistics and error estimates:

Not applicable

Sublethal observations / clinical signs:

Toxicity to fish (definitive test):

Concentrations ppm (w/w) expressed as solid content	N° vessel	Number of dead fish
		3h	24h	48h	72h	96h
Control	1	0	0	0	0	0
	2	0	0	0	0	0
10	3	0	0	5	-	-
	4	0	0	5	-	-
17	5	0	4	1	-	-
	6	0	3	3	-	-
32	7	4	1	-	-	-
	8	4	1	-	-	-
60	9	5	-	-	-	-
	10	5	-	-	-	-
100	11	5	-	-	-	-
	12	5	-	-	-	-

Toxicity to fish (complementary test):

Concentrations ppm (w/w) expressed as solid content	N° vessel	Number of dead fish
		3h	24h	48h	72h	96h
Control	1	0	0	0	0	0
	2	0	0	0	0	0
2	3	0	0	0	0	0
	4	0	0	0	0	0
3	5	0	0	0	0	0
	6	0	0	0	0	0
6	7	0	1	2	2	-
	8	0	2	2	1	-
10	9	5	5	-	-	-
	10	5	5	-	-	-
17	11	5	5	-	-	-
	12	5	5	-	-	-

Toxicity to fish (definitive + complementary test):

Concentrations ppm (w/w) expressed as solid content	Test	N° vessel	Mortality (cumulated) %
			24h	48h	72h	96h
Control	D	1 + 2	0	0	0	0
	C	1 + 2	0	0	0	0
	D+C	-	0	0	0	0
2	C	3 + 4	0	0	0	0
3	C	5 + 6	0	0	0	0
6	C	7 + 8	30	70	100	-
10	D	3 + 4	0	100	-	-
	C	9 + 10	100	-	-	-
	D + C	-	50	100	-	-
17	D	5 + 6	60	100	-	-
	C	11 +12	100	-	-	-
	D + C	-	80	100	-	-
32	D	7 + 8	100	-	-	-
60	D	9 + 10	100	-	-	-
100	D	11 + 12	100	-	-	-

D: definitive test   
C: complementary test     
D + C: mean of the mortality definitive test + complementary test

Physical-chemical measurements (definitive test): 

Concentrations ppm (w/w) expressed as solid content	N° vessel	pH				Dissolved oxygene (%)
		24 h	48h	72h	96h	24 h	48h	72h	96h
Control	1	7.8	7.9	7.9	7.9	68	69	68	70
	2	7.8	7.9	7.9	7.9	63	67	68	71
10	3	7.8	8.1	-	-	68	87	-	-
	4	7.8	8.2	-	-	68	86	-	-
17	5	8.0	8.3	-	-	73	93	-	-
	6	8.0	8.3	-	-	68	93	-	-
32	7	8.3	-	-	-	90	-	-	-
	8	8.4	-	-	-	90	-	-	-
60	9	8.4	-	-	-	89	-	-	-
	10	8.4	-	-	-	91	-	-	-
100	11	8.4	-	-	-	95	-	-	-
	12	8.4	-	-	-	94	-	-	-

Physical-chemical measurements (complementary test):

Concentrations ppm (w/w) expressed as solid content	N° vessel	pH				Dissolved oxygene (%)
		24 h	48h	72h	96h	24 h	48h	72h	96h
Control	1	7.9	8.0	8.0	7.9	65	73	71	69
	2	7.9	8.0	7.9	7.9	61	67	63	65
2	3	8.0	8.0	7.9	7.9	62	67	69	65
	4	8.0	8.1	7.9	8.0	61	68	70	72
3	5	7.9	8.0	7.9	7.9	65	69	69	68
	6	7.9	8.0	7.9	7.9	65	65	66	65
6	7	8.0	8.2	8.3	-	65	78	94	-
	8	8.0	8.3	8.3	-	66	86	94	-
10	9	8.3	-		-	73	-	-	-
	10	8.4	-		-	78	-	-	-
12	11	8.5	-			82	-	-	-
	12	8.5	-		-	92	-	-	-

 

Validity criteria fulfilled:

yes

Conclusions:

96h-LC50: 10.6 mg/L (based on test material)
96h-LC50: 4.2 mg/L (based on solid content)

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2007-06-05 to 2007-06-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: highest concentration and control
- Sampling Method: 2 mL from the approximate centre of the test vessel at t=0 h, t = 24 h and t = 96 h
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with two solutions of 100 mg a.i./L (198 mg/L, based on formulation) applying 16 minutes of magnetic stirring to accelerate the dissolving of the test substance in the test medium, after which the solutions were pooled. Part of the solution was used as highest test concentration and part was used to prepare the lower test concentrations.
- Controls: Test medium without test substance or other additives
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The final test solutions were all clear and colourless.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Length at study initiation (length definition, mean, range and SD): 2.7 ± 0.1 cm
- Weight at study initiation (mean and range, SD): 0.56 ± 0.1 g
- Method of breeding: F1 from a single parent-pair bred in UV-treated water.
- Feeding during test: No feeding from 24 hours prior to the test and during the total test period.

ACCLIMATION
- Acclimation period: At least 12 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: pelleted fish food (Nutra 3.0 T, TROUW NUTRITION, Putten, The Netherlands)
- Feeding frequency: Daily
- Health during acclimation (any mortality observed):In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

180 mg CaCO3 per litre and a pH of 7.7 ± 0.3

Test temperature:

control: 20.7 - 21.4°C
100 mg/L: 20.9 - 21.1°C

pH:

control: 7.4 - 7.6
100 mg/L: 7.2 - 7.5

Dissolved oxygen:

control: 5.9 (aeration introduced on day 2) - 8.9 mg/L
100 mg/L: 6.0 (aeration introduced on day 2) - 8.9 mg/L

Nominal and measured concentrations:

nominal: 0, 0.1, 1.0, 10 and 100 mg/L
Analysis of the samples taken during the combined limit/range-finding test showed that measured concentrations were stable and in agreement with nominal throughout the 96-hour test period (96-98%)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 10 L, all-glass, containing 9 L of test solution.
- Aeration: The test media were not aerated, except for a period of 22.5 hours during nominal days 2 and 3 of the test.
- No. of organisms per vessel: 3 (0.1, 1, 10 mg a.i./L), 7 (control and 100 mg a.i./L)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: Control and 100 mg a.i./L: 0.44 g fish/L; 0.10, 1.0 and 10 mg a.i./L: 0.19 mg fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, nitrate and nitrite concentration and ammonia concentration: once a week. Temperature: daily.
In addition, pH and temperature were measured before transferring the fish to the test system.

OTHER TEST CONDITIONS
- Adjustment of pH: yes, pH 7.7 ± 0.3
- Photoperiod: 16 h/d


EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Mortality and sublethal effects at 4, 24, 48, 72 and 96 hours. In addition, every afternoon from day 0 and every morning from day 1 to observe for any dead or severely distressed fish.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Test concentrations: 0, 0.1, 1, 10 and 100 mg a.i./L

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

No mortality or clinical effects were observed at any of the concentrations tested.

Results with reference substance (positive control):

- Results with reference substance valid: Yes
96h LC50 = 0.15 mg/L (95% ci 0.10 - 0.22 mg/L)
range of historical data: 96h LC50 0.10 - 0.46 mg/L

Sublethal observations / clinical signs:

Analysis of the samples taken during the combined limit/range-finding test showed that measured concentrations were stable and in agreement with nominal throughout the 96-hour test period (96-98%).

All test conditions remained within the ranges prescribed by the protocol (pH: 6.0-8.5, constant within 1 unit; temperature 20-24°C, constant within 2°C; oxygen > 60% of air saturation). Aeration was introduced after 48 hours of exposure, as the oxygen concentration tended to drop below the optimum level for testing with carp, i.e. below 5 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present test Amphopropionate C8 induced no visible effects in carp at or below 100 mg a.i./L. Hence, the 96 h LC50, exceeded 100 mg/L, based on active ingredient concentrations.

Executive summary:

In a 96 h acute toxicity study according to OECD 203 guideline (1992) and EU Method C.1 (1992), carp (Cyprinus carpio) were exposed to Amphopropionate C8 (50.6% a.i.) at nominal concentrations of 0 (control), 0.1, 1.0, 10 and 100 mg a.i./L under static conditions. Analysis of the samples taken during the combined limit/range-finding test showed that measured concentrations were stable and in agreement with nominal throughout the 96-hour test period (96-98%). 3 test organisms were exposed to 0.1, 1 and 10 mg a.i./L and 7 test organisms to 0 mg a.i./L (control) and 100 mg a.i./L.

The 96 h LC50 was > 100 mg a.i./L.  The EC50 and NOEC values, based on mortality/sublethal effects, were both > 100 mg a.i./L.  No visible sublethal effects were observed under the conditions of the present test. 

This toxicity study is classified as acceptable and satisfies the guideline requirement for an OECD 203 guideline and EU Method C.1 toxicity study.

Results Synopsis

Test organism size/age: Cyprinus carpio (mean length: 2.7 ± 0.1 cm; mean weight: 0.56 ± 0.1 g)

Test Type: static

LC50:  > 100 mg a.i./L                       

NOEC:  > 100 mg a.i./L                       

Endpoint(s) Effected: mortality and sublethal effects

Description of key information

96 h LC50 = 4.2 mg/L (Oncorhynchus mykiss; OECD TG 203; RL2; GLP) read-across: Amphoacetates C8-C18

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

4.2 mg/L

Additional information

No experimental data on acute toxicity to fish are available for the target substance Amphopropionates C12-18. However, short-term toxicity studies are available for the closely related source substances Amphopropionate C8 and Amphoacetates C8-C18. A justification for read-across is given in the Endpoint summary Aquatic toxicity.

 

In a 96 h acute toxicity study according to OECD Guideline 203 (1992) and EU Method C.1 (1992), carp (Cyprinus carpio) were exposed to Amphopropionate C8 (50.6% a.i.) at nominal concentrations of 0 (control), 0.1, 1.0, 10 and 100 mg a.i./L under static conditions. Analysis of the samples taken during the combined limit/range-finding test showed that measured concentrations were stable and in agreement with nominal throughout the 96-hour test period (96-98%). 3 test organisms were exposed to 0.1, 1 and 10 mg a.i./L and 7 test organisms to 0 mg a.i./L (control) and 100 mg a.i./L.

The 96 h LC50 was > 100 mg a.i./L.  The EC50 and NOEC values, based on mortality/sublethal effects, were both > 100 mg a.i./L.  No visible sublethal effects were observed under the conditions of the present test. 

 

In a 96 h acute toxicity study according to OECD Guideline 203 and EU Method C.1, rainbow trout (Oncorhynchus mykiss) were exposed to Amphoacetates C8-C18 at nominal concentrations of 0 (control), 10, 17, 32, 60 and 100 mg/L in the definitive test and 0 (control), 2, 3, 6, 10 and 17 mg/L in the complementary test under semi-static conditions. Analytical monitoring was not performed.

The 96 h LC50 based on test material was 10.6 mg/L. The 96 h LC50 based on solids content was 4.2 mg/L.

 

In a 96 h acute toxicity study according to OECD Guideline 203 and EU Method C.1, zebra fish (Danio rerio) were exposed to Amphoacetates C8-C18 at nominal concentrations of 0 (control), 16, 19, 22, 25, 40 and 63 mg/L under semi-static conditions.

The 96 h LC50 based on test material was 25 mg/L. The 96 h LC50 based on solids content was 8.5 mg/L.

 

The 96 h LC50 of acrylic acid to Oncorhynchus mykiss was reported to be 27 mg/L.

 

For chemical safety assessment the lowest 96 h LC50 of 4.2 mg/L will be used.