Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From February 23, 1996 to April 05, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

KL 2 due to RA and no analytical dose verification.

Justification for type of information:

Refer to the section 13 for details on the category justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Solvent control: 100 µL/L Tetrahydrofuran
- Chemical name of vehicle (organic solvent): Tetrahydrofuran
- Concentration of vehicle in test medium (stock solution): 30 mg/mL
- Preparation of test solution: Test material (300 mg) was dissolved in 10 mL (final volume) of tetrahydrofuran to give the solvent stock solution from which an aliquot (2.0 mL) was dispersed in 20 L (final volume) of dechlorinated tap water to give the test concentration of 3.0 mg/L.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Donnington Fish Farm, Upper Swell, Gloucestershire, UK
- Age at study initiation (mean and range, SD): Juvenile
- Length at study initiation (length definition, mean, range and SD): 4.8 cm (SD = 0.2)
- Weight at study initiation (mean and range, SD): 1.56 g (SD = 0.15)
- Feeding during test: No


ACCLIMATION
- Acclimation period: 8 d
- Acclimation conditions (same as test or not): Maintained in a glass fiber tank with a single pass water renewal system
- Type and amount of food: Commercial trout pellets, discontinued 24 h prior to definitive study

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

100 mg/L as CaCO3

Test temperature:

14 ± 1°C

pH:

7.4-7.9

Dissolved oxygen:

≥ 9.1 mg O2/L

Nominal and measured concentrations:

Nominal concentrations:
- Range finding study: 0.30 and 3.0 mg/L
- Definitive study: 3.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 20 L glass exposure vessel
- Aeration: Aerated via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): Daily
- No. of organisms per vessel: Three in range finding study, ten in definitive study
- No. of vessels per concentration (replicates): Two
- No. of vessels per vehicle control (replicates): Two
- Biomass loading rate: 0.78 g bw/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water


OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h darkness


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: 3 mg/L was reported to be highest attainable test concentration based on the solubility of the test material under the test conditions
- Range finding study
- Test concentrations: 0.30 and 3.0 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: -

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: -

Details on results:

- Behavioural abnormalities: No
- Mortality of 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: No

Sublethal observations / clinical signs:

Table 1: Cumulative mortality data in the range-finding study

 

Nominal concentration (mg/L)	Cumulative Mortality (Initial Population: 3)
	24 h	48 h	72 h	96 h
Control	0	0	0	0
Solvent Control	0	0	0	0
0.3	0	0	0	0
3	0	0	0	0

 

Table 2: Cumulative mortality data in the definitive study

 

Nominal concentration (mg/L)	Cumulative Mortality (Initial Population: 10)						% mortality
	3 h	6 h	24 h	48 h	72 h	96 h	96 h
Control	0	0	0	0	0	0	0
Solvent control	0	0	0	0	0	0	0
3.0 R1	0	0	0	0	0	0	0
3.0 R2	0	0	0	0	0	0	0

* R1-R2 = Replicates 1 & 2

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively

Executive summary:

A study was conducted to determine the acute toxicity of the read across substance, C8-18 and C18-unsatd. MEA, to Rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Based on the results of a range-finding study, fish (10 per group) were exposed to an aqueous dispersion of the test substance at a concentration of 3 mg/L, the highest attainable concentration due to limited water solubility, for 96 h under semi-static conditions. The substance was previously dissolved in tetrahydrofuran and a solvent control was run in parallel with the negative control and the test substance groups. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively (Wetton, 1996).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From February 28, 1983 to March 04, 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

No analytical dose verification.

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

Deviations:

yes

Remarks:

(Control data not reported)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

(Control data not reported)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Chemical name of vehicle: Water
- Concentration of vehicle in test medium (stock solution): Stock suspension of 10 g/L was prepared from which appropriate aliquots were pipetted into the test vessels and filled up to final volume of 5 L with standard dilution water.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Feeding: Not during the test
- Mortality (prior to test): < 0.1%
- Pretreatment: None

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

About 250 mg CaCO3/L

Test temperature:

22.0-23.5°C

pH:

7.4-7.8

Dissolved oxygen:

62-92%

Nominal and measured concentrations:

Nominal : 11, 16, 22, 32, 45 and 90 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: 10 L fish basins containing 5 L test water
- Fill volume: 5 L
- No. of organisms per concentration: 10
- Renewal rate of test solution (frequency/flow rate): Daily


TEST MEDIUM: Standard dilution water


OTHER TEST CONDITIONS
- Photoperiod: About 16 h daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities were recorded at 0, 6, 24, 48, 72 and 96 h

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC10

Effect conc.:

ca. 11 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.:

ca. 31 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

ca. 90 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No

Sublethal observations / clinical signs:

Table 1: Mortality (%)

Conc. (mg product/L)	Incubation time (h)
	0	6	24	48	72	96
11	0	0	0	0	n.d.	0
16	0	0	20	20	n.d.	20
22	0	10	10	40	n.d.	40
32	0	0	40	10	n.d.	10
45	0	30	80	90	n.d.	90
90	0	100	100	100	n.d.	100

n.d.=not determined

Validity criteria fulfilled:

not specified

Remarks:

(Control data not reported)

Conclusions:

Under the study conditions, the 96 h LC0, LC50 and LC100 were 11, 31 and 90 mg/L, respectively.

Executive summary:

A study was conducted to assess the acute toxicity of the test substance, C12-18 and C18-unsatd. MEA, to Zebrafish (Danio rerio) according to OECD Guideline 203 and ISO Method 7346/2 under semi static conditions. The fish (10 per dose) were exposed to the test substance (directly dissolved in test medium) in a concentration range of 11-90 mg/L for 96 h and immobility was determined at 96 h. No analytical dose verification was conducted. Under the study conditions, the 96 h LC0, LC50 and LC100 were 11, 31 and 90 mg/L, respectively (Gode, 2001).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

3 mg/L

Additional information

A study was conducted to determine the acute toxicity of the read across substance, C8-18 and C18-unsatd. MEA, to Rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Based on the results of a range-finding study, fish (10 per group) were exposed to an aqueous dispersion of the test substance at a concentration of 3 mg/L, the highest attainable concentration due to limited water solubility, for 96 h under semi-static conditions. The substance was previously dissolved in tetrahydrofuran and a solvent control was run in parallel with the negative control and the test substance groups. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC were >3 and 3 mg/L, respectively (Wetton, 1996).

A study was conducted to assess the acute toxicity of the test substance, C12-18 and C18-unsatd. MEA, to Zebrafish (Danio rerio) according to OECD Guideline 203 and ISO Method 7346/2 under semi static conditions. The fish (10 per dose) were exposed to the test substance (directly dissolved in test medium) in a concentration range of 11-90 mg/L for 96 h and immobility was determined at 96 h. No analytical dose verification was conducted. Under the study conditions, the 96 h LC0, LC50 and LC100 were 11, 31 and 90 mg/L, respectively (Gode, 2001).