Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine

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:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Guideline compliant study with good documentation, no dose verification, biomass loading slightly exceeded.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: OSPAR 1995

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
A cloudy white solution of [Trade name] (Triethanolamine salt of oleic acid) in seawater was examined according to the method described in the Harmonized Offshore Chemical Notification Format (OSPAR, 1995). For the pretest, a nominal concentration of 1000 mg/L was preparedin dilution water, shaken vigorously and allowed to stand for four hours.
A cloudy white solution with neutrally buoyant material was observed. For each nominal concentration the required amount of homogenized sample was added to 12 litres of dilution water, mixed for 20-24 hours and then allowed to separate for four hours. The solution was filtered using Whatman No.54 filter papers, the filtrate was used for the test.
The preliminary study had identified the 96 hour LC50 as greater than 1000 mg/L and therefore definitive test concentrations were prepared as 0 (control), 560, 1000 and 1800 mg/L.
Volumes of 10 litres of test solution were prepared in aquaria. A control vessel of 10 litres dilution water was prepared.
- Controls: Dilution water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): A cloudy white solution with neutrally buoyant material was observed. the solution was filtered. The characteristics of the filtered solution were not reported.

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

TEST ORGANISM
- Common name: Turbot
- Source: France Turbot, Boite Postale 305, 58330 noirmoutiers, France
- Length at end of study (length definition, mean, range and SD): Mean 48.3 mm
- Weight at end of study (mean and range, SD): Mean 1.68 g

ACCLIMATION
- Acclimation period: 9 to 28 September 2004
- Acclimation conditions (same as test or not): Temperature and DO reported: these parameters were within the range used for the test; other parameters were not reported.
- Type and amount of food: Not reported
- Feeding frequency: Not reported
- Health during acclimation (any mortality observed): Not reported

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

14.0 - 15.5°C

pH:

7.6 - 8.3

Dissolved oxygen:

72- 100% ASV

Salinity:

34 - 35 g/L sodium chloride

Nominal and measured concentrations:

nominal concentrations: 0 (control), 560, 1000, 1800 mg test item/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquaria (no further details provided)
- Material, size, headspace, fill volume: Fill volume 10 L
- Aeration: Not reported
- Renewal rate of test solution (frequency/flow rate): Renewal at 48 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1.176 g/L (This exceeds the limit provided in the OECD 203 guideline of 1 g/L for static and semi-static tests. However, this deviation is minor and not considered critical for the interpretation of the results.)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The stocks of animals were maintained, and the tests performed in standardized artificial seawater using Tropical Marine artificial sea salt formulated by Tropical Marine Centre Limited. The measured salinity of the seawater used was 34 to 35 g/L sodium chloride.
- Culture medium different from test medium: No
- Intervals of water quality measurement: In the test in the freshly prepared, 24 hours aged and 48 hour aged test solutions.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light and 8 hours dark
- Light intensity: Not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Justification for using less concentrations than requested by guideline: Based on the results of the pretest, less concentrations were used since no effect was expected at 1000 mg/L. Rational: Animal protection.
- Range finding study: Yes
- Test concentrations of the range finder: 1000 mg/L (WAF, preparation see above)
- Results used to determine the conditions for the definitive study: No mortality at 1000 mg/L

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 1 800 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No abnormal behaviour of the turbot was recorded in any test solution at any time point.
- Observations on body length and weight: NA
- Other biological observations: NA
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The concnetration of the test item in the test solutions was not analytically determined. However, a cloudy white solution with neutrally buoyant material was observed. For each nominal concentration the required amount of homogenized sample was added to 12 litres of dilution water, mixed for 20-24 hours and then allowed to separate for four hours. The solution was filtered using Whatman No.54 filter papers, the filtrate was used for the test. Hence, it is likely that the exposure concentrations were lower than the nominal concentrations.
- Effect concentrations exceeding solubility of substance in test medium: The test solutions were prepared as WAF and hence the dissolved concentrations were likely to be lower than the nominal concentrations.

Reported statistics and error estimates:

not needed since no mortaility was observed

Validity criteria fulfilled:

yes

Executive summary:

In the GLP Klimisch 2 study from Sacker (2004) the acute toxicity of the test material (Triethanolamine salt of oleic acid) to Turbot (Scophthalmus maximus) was determined in a semi-static test with renewal of the test solutions after 48 hours.

Since the test substance is a UVCB substance of low water solubility the test was performed on water accommodated fractions (WAF) as recommended by OECD. The nominal loading rates were 0 (control), 560, 1000 and 1800 mg test item/L.

For each nominal concentration the required amount of homogenized sample was added to 12 litres of dilution water, mixed for 20-24 hours and then allowed to separate for four hours. A cloudy white solution with neutrally buoyant material was observed. The solution was filtered using Whatman No.54 filter papers, the filtrate was used for the test.

For each of the test solutions and the control, one replicate with seven fish (mean weight 1.68 g/fish) per replicate was set up.

 The test was performed according OECD 203, adapted to marine conditions. Deviations to the guideline were minor, e.g., the biomass loading was with 1.176 g/L slightly higher than the recommended 1 g/L. This deviation is considered to have no impact on the general interpretation of the results of this study. the test was performed without dose verification analysis.

During the study, the temperature of the test solutions ranged from 14.0 - 15.5°C. After 96 hours of exposure, no fish had died in the control or any test solution. Adverse effects were not recorded at any time in any test group. The 96 h LL50 was determined to be > 1800 mg test item /L. The concentrations were based on nominal concentrations.

The results of this study are considered to be relevant for the risk assessment.

Description of key information

96h-LC50: > 1800 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1 800 mg/L

Additional information

In the GLP Klimisch 2 study from Sacker (2004) the acute toxicity of the test material (Triethanolamine salt of oleic acid) to Turbot (Scophthalmus maximus) was determined in a semi-static test with renewal of the test solutions after 48 hours.

Since the test substance is a UVCB substance of low water solubility the test was performed on water accommodated fractions (WAF) as recommended by OECD. The nominal loading rates were 0 (control), 560, 1000 and 1800 mg test item/L.

For each nominal concentration the required amount of homogenized sample was added to 12 litres of dilution water, mixed for 20-24 hours and then allowed to separate for four hours. A cloudy white solution with neutrally buoyant material was observed. The solution was filtered using Whatman No.54 filter papers, the filtrate was used for the test.

For each of the test solutions and the control, one replicate with seven fish (mean weight 1.68 g/fish) per replicate was set up.

 The test was performed according OECD 203, adapted to marine conditions. Deviations to the guideline were minor, e.g., the biomass loading was with 1.176 g/L slightly higher than the recommended 1 g/L. This deviation is considered to have no impact on the general interpretation of the results of this study. the test was performed without dose verification analysis.

During the study, the temperature of the test solutions ranged from 14.0 - 15.5°C. After 96 hours of exposure, no fish had died in the control or any test solution. Adverse effects were not recorded at any time in any test group. The 96 h LL50 was determined to be > 1800 mg test item /L. The concentrations were based on nominal concentrations.

The results of this study are considered to be relevant for the risk assessment.