Fatty acids, C16-18, esters with ethylene glycol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

15 Apr - 19 Apr 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. No analytical dose verification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test material

Test material information

Constituent 1

Reference substance name:

Ethylene distearate

EC Number:

211-014-3

EC Name:

Ethylene distearate

Cas Number:

627-83-8

Molecular formula:

C38H74O4

IUPAC Name:

ethane-1,2-diyl dioctadecanoate

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 100 mg of the test substance was dissolved in 10 mL of the solubiliser tetrahydrofuran to give a 100 mg/10 mL solvent stock solution. An aliquot (3.0 mL) of this initial stock solution was dissolved in a further 10 mL (final volume) of solvent to prepare a 30 mg/10 mL secondary solvent stock solution. An aliquot (2.0 mL) of this was directly dispersed in 20 L of dechlorinated tap water to give a final test concentration of 0.30 mg/L.
- Eluate: No
- Differential loading: No
- Controls: one control (only test medium) and one solvent control (100 µL tetrahydrofuran/L) were used
- Chemical name of vehicle: tetrahydrofuran
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 100 µL/L
- Evidence of undissolved material: Precipitation of the test material at test concentrations in excess of 0.30 mg/L as obtained in the range-finding study.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: obtained from Donnington Fish Farm, Upper Swell, Gloucestershire, UK
- Length at study initiation: 5.0 cm ± 0.3 cm
- Weight at study initiation: 1.62 g ± 0.33 g
- Feeding during test: none


ACCLIMATION
- Acclimation period: from 08 Apr 1996 - 15 Apr 1996
- Acclimation conditions: same as test conditions
- Type and amount of food: fed with commercial trout pellets
- Health during acclimation: less than 1% (mortality)

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Test temperature:

14 °C

pH:

7.7 - 8.0

Dissolved oxygen:

9.2 - 9.7 mg/L

Nominal and measured concentrations:

Nominal: 0, 0.3 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass exposure vessels
- Type: covered to reduce evaporation
- Material, size, headspace, fill volume: glass, 20 L, headspace: 0 L, fill volume: 20 L
- Aeration: aerated via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): renewed every day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.81 g/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water dechlorinated by passage through an activated carbon filter was used with a total hardness of approx. 100 mg/L as CaCO3.
- Total organic carbon: 1 mg/L
- Chlorine: 0.16 mg/L
- Conductivity: 405 µS/cm


OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark


EFFECT PARAMETERS MEASURED: Mortality and behavioural abnormalities were recorded after 3, 6, 24, 48, 72 and 96 h after the start of exposure


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: No effects in the range finding study up to the limit of water solubility were observed. Thus, a limit test was performed.
- Range finding study
- Test concentrations: control - solvent control - 0.03 mg/L - 0.3 mg/L
- Results used to determine the conditions for the definitive study: No effects were observed in the range-finding study.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 0.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No behavioural abnormalities were observed
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: During prelimary solubility trials concentrations above 0.30 mg/L resulted in precipitation of the test substance on the water surface.

Any other information on results incl. tables

Sublethal observations / clinical signs:

No behavioural abnormalities and effects of the solubiliser were observed in the solvent control.