Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl)

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:

From February 23, 1996 to April 05, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

No analytical dose verification.

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)

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)

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 test 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).

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 test 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).