Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]

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:

key study

Study period:

1984-01-12 to 1984-03-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Follows OECD guideline 203 (1992) with insignificant deviation (tested in the presence of emulsifier). Effective concentrations exceed by far limit of water solubility. Contains sufficient detail to suggest GLP-like characteristics. Dated and signed quality assurance inspection statements included.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

fish length; Use of emulisifier and testing of doses exceeding by far limit of water solubility

GLP compliance:

no

Remarks:

Study pre dates ecotoxicology GLP requirements

Analytical monitoring:

yes

Details on sampling:

Samples for analysis were taken at 0 and 96 hours. Actual values are average of measured concentrations. The analytical method was not mentioned.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stock solution was prepared by dissolving 100 g of the test item in DMSO; 3000 mg Marlopon AT50 and made up to 1000 ml with DMSO
- Controls: blank with water; vehicle with 1101 mg DMSO, 3 mg Marlopon AT50 per liter water in the concentration used for the highest test concentraiton
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): DMSO, MARLOPON AT 50
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

TEST ORGANISM
- Common name: bluegill
- Source: Osage catfisheries
- Length at study initiation (length definition, mean, range and SD): 34 mm (30-40 mm)
- Weight at study initiation (mean and range, SD): 0.47 g (0.39 - 0.53 g)
- Feeding during test: no

Acclimatization
- 53 days

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

168 mg CaCo3/L

Test temperature:

23 ± 1°C

pH:

8.0 - 8.1

Dissolved oxygen:

89 % to 103 %

Nominal and measured concentrations:

Nominal: 5.8, 10, 18, 32, 58, 100 mg/l
Actual: 4.4, 7.5, 11.5, 26.1, 46.2, 59.3 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Type: open
- Material, size, headspace, fill volume: 20 litres filled with 15 litres (36/22/25 cm)
- Aeration: gentle aeration during the test
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- No. of vessels per vehicle control (replicates):1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: declorinated tap water (carbon filter)

OTHER TEST CONDITIONS
- Photoperiod: 16 hours daily
- Light intensity: fluorescent light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
observations: mortality and symptoms after 24, 48, 72, and 96 h
measurements: pH, temperature and oxygen content after 0, 24, 48, 72 and 96 h

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

43 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 36 to 59 mg/L CL

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

70 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

64 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

59 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

11.5 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: determined graphically

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

44 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: determined graphically

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 59.3 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: determined graphically

Details on results:

No mortalities occured in the blank and vehicle control, respectively.
Slight effects on pigmentation occured in all test concentrations after 48 hours. In the four highest test cocentrations, slight effects on respiratory function occured after 24 hours, after 96 hours in the two highest concentrations moderate effects were observed. After 24 hours, moderate effects on loss of equilibrium were observed in the three highest concentrations, after 96 hours severe effects on loss of equilibrium were observed in the two highest test concentrations. Slight effects on swimming behaviour were observed at concentrations of 7.5, 11.5 and 26.1 mg/L, in the two highest test concentrations moderate effects were observed after 24 hours. After 72 hours severe effects on the swimming behaviour were observed in the three highest test concentrations.

Reported statistics and error estimates:

The LC50 values were calculated according the J.Berksoon, JASA 48 (1953). LC50 (96h) was graphically determined on gausso-logarithmic probablity paper.

Validity criteria fulfilled:

yes

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1984-01-12 to 1984-04-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Complies with OECD guideline 203. Dated and signed quality assurance statement included. Use of emulisifier and testing of doses exceeding by far limit of water solubility.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Use of emulisifier and testing of doses exceeding by far limit of water solubility

GLP compliance:

no

Remarks:

Study pre dates ecotoxicology GLP requirements

Analytical monitoring:

yes

Details on sampling:

Samples for analysis from each test concentration were taken at 0 and 96 hours.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 100g of the test item were dissolved in DMSO; 3000 mg MARLOPON AT 50 and made up to 1000 ml with DMSO
- Controls: water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): DMSO,MARLOPON AT 50
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 1101 mg DMSO; 3 mg MARLOPON AT 50 per liter water in the concentration used for the highest test concentration.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: P. Hohler/CH-4314 Zeiningen
- Length at study initiation (length definition, mean, range and SD): 56 mm (50 to 60 mm)
- Weight at study initiation (mean and range, SD): 2.0 g (1.4 - 2.5 g)
- Feeding during test: None

ACCLIMATION
- Acclimation period: 41 days

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

168 mg CaCO3/L

Test temperature:

15 ± 1°C

pH:

8.0

Dissolved oxygen:

85-100%

Nominal and measured concentrations:

Nominal: 10, 18, 32, 58, 100 mg/L.
Actual: 5.1, 10.6, 19.1, 37, and 56.3 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria for 20 liters (36/22/25 cm) filled with 15 liters
- Aeration: gentle aeration during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates):2
- No. of vessels per control (replicates):2
- No. of vessels per vehicle control (replicates):2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water (carbon filter)
- Alkalinity: pH about 8.0

OTHER TEST CONDITIONS
- Photoperiod: Fluorescent light , 16 hours daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
observations: mortality and symptoms after 24, 48, 72, and 96 h
measurements: pH, temperature and oxygen content after 0, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
Nominal test concentrations: 10, 18, 32, 58 and 100 mg/l. In addition, a blank and a vehicle control were tested in parallel.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 56 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 56 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 56 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 56 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

37 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 56 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of test substance: 1 fish at 56.3 mg/L after 96 hours
- Mortality of control: Blank (water) - 10%, Vehicle - 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: the test substance precipitated immediately at concentrations greater than 100 mg/l

Reported statistics and error estimates:

None performed

Validity criteria fulfilled:

yes

Conclusions:

Effect concentrations exceeding by far limit of water solubility due to use of emulisifier.

Description of key information

With high probability acutely not harmful to fish. 

Additional information

Two non-GLP studies are available on the short term toxicity to fish according to OECD guideline 203. Due to the low water solubility of the test substance in both studies emulsifier (1101 mg DMSO; 3 mg MARLOPON AT50 per L water in the highest test concentration) have been used. The test substance appeared homogeneously distributed at all test concentrations. No toxic effects occur within the range of water solubility (LC0 and LC50 after 96 h exceed by far water solubility) for rainbow trout. LC50 values for bluegill were calculated to be 43 mg/L. No toxic effects could be recorded in the range of water solubility.