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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline compliant study with good documentation

Qualifier:

according to guideline

Guideline:

other: ISO 14669: Determination of acute lethal toxicity to marine copepods (Copepods, Crustacea)

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples of the water accommodated fractions with loading 100 and 1000 mg/L and the control medium were taken at the start of the test and analysed for content of total organic carbon (TOC).

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method: The test substance is a multi-component substance of low water solubility. Therefore the test was performed on water accommodated fractions (WAF) as recommended by OECD. Separate WAFs were prepared for 5 loading rates from 100 to 1000 mg/l. The test substance was transferred to 0.5 l of the test medium in 1 l sealed glass bottles. The flasks were placed on a reciprocating shaker. The WAF extraction was performed in the darkness in a room controlled at 21±1 °C. After 22 hours, the agitation was terminated and approximately two hours later, 200 ml of each WAF was drawn with a pipette, avoiding the settled material at the bottom of the flasks. All WAFs with loadings were slightly turbid and were filtered through Whatmen GF/C fibre filters to remove non settling suspended material.

Test organisms (species):

other aquatic crustacea: Acartia tonsa

Details on test organisms:

TEST ORGANISM
- Common name: Acartia tonsa
- Source: Marine Research Laboratory, Helsingör, Denmark
- Age at study initiation (mean and range, SD): 17- 30 days

Cultured in natural seawater; fed with Nephroselmis pyriformis and Rhodomonas baltica

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

Preparation of WAF: 21.0 - 21.6°C
Test temperature: 20.1 - 20.3°C

pH:

7.8 - 8.1

Dissolved oxygen:

7.1 - 7.3 mg/L

Salinity:

32 S

Nominal and measured concentrations:

Nominal concentrations: Control, 100, 180, 320, 560 and 1000 mg/L, measured concentrations in the control and 100 and 1000 mg/L test solutions were 0.95, 6.7 and 40.4 mg TOC/L.The results indicate that less than 10 % of the test substance partitioned to the water phase as dissolved organic matter. (The estimate is based on the assumption that the carbon content of the test substance is 70% by weight).

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL polysterene beakers
- No. of organisms per vessel: 5 - 8
- No. of vessels per concentration (replicates): 16
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): none
- Biomass loading rate: NA

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: natural seawater, taken at 60 depth at Solbergstrand Research Station in outer Oslo Fjord, The salinity was adjusted to 32 S using destilled water
- Intervals of water quality measurement: pH at start and end, DO at end of the exposure.

OTHER TEST CONDITIONS
- Adjustment of pH: not reported
- Photoperiod: in the dark
- Light intensity: in the dark

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: NA
- Range finding study: not reported

Reference substance (positive control):

yes

Remarks:

3,5 dichlorophenol

Duration:

48 h

Dose descriptor:

LL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Behavioural abnormalities: Not assessed
- Observations on body length and weight: Not assessed
- Other biological observations: Mortality
- Mortality of control: 1 %
- Other adverse effects control: 1 out to 146 animals
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Not reported for the final test solutions
- Effect concentrations exceeding solubility of substance in test medium: Yes (WAF)

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Mortality: 30 % at 1 mg/L, validity criterion: Within 20 - 80%)

Reported statistics and error estimates:

Not calculated since less than 50 % mortality in any of the test solutions.

Number of alive Acartia tonsa after 24 and 48 hours

Loading (mg test item/L)	Number of aliveAcartia tonsa			Percent alive after 48 hours
	Start	24 h	48 h
0 (control)	146	146	145	99
100	22	21	20	91
180	26	26	26	100
320	29	29	28	97
560	26	25	25	96
1000	26	25	25	96

 

Validity criteria fulfilled:

yes

Executive summary:

In the Klimisch 1 study from Sverinsen (2004) the acute toxicity of the test material (Triethanolamine salt of oleic acid) to the marine crustacean Acartia tonsa was determined in a 48 h static GLP acute lethal toxicity to marine copepods. The test design was based on ISO 14669: "Determination of acute lethal toxicity to marine copepods (Copepods, Crustacea)".

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), 100, 180, 320, 560 and 1000 mg test item/L. The WAF extraction was performed in the darkness in a room controlled at 21±1 °C. After 22 hours, the agitation was terminated and approximately two hours later, 200 ml of each WAF was drawn with a pipette, avoiding the settled material at the bottom of the flasks. All WAFs with loadings were slightly turbid and were filtered through Whatmen GF/C fibre filters to remove non settling suspended material.

Sixteen control replicates and 4 replicates from each test solution were set up. Each replicate received 5 - 8 animals. Dose verification analysis was performed by TOC analysis of the control, 100 and 1000mg/L test solutions at the start of the test. The test was performed in darkness. A test with a reference substance gave a valid result.

Since only minor mortality was observed resulting in < 10% mortality in any of the tested WAFs the highest loading tested resulting in 50% mortality (LL50) is >1000 mg/l.

This study is considered to be acceptable for the risk assessment.

Description of key information

48h-LL50: > 1000 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1 000 mg/L

Additional information

In the Klimisch 1 study from Sverinsen (2004) the acute toxicity of the test material (Triethanolamine salt of oleic acid) to the marine crustacean Acartia tonsa was determined in a 48 h static GLP acute lethal toxicity to marine copepods. The test design was based on ISO 14669: "Determination of acute lethal toxicity to marine copepods (Copepods, Crustacea)".

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), 100, 180, 320, 560 and 1000 mg test item/L. The WAF extraction was performed in the darkness in a room controlled at 21±1 °C. After 22 hours, the agitation was terminated and approximately two hours later, 200 ml of each WAF was drawn with a pipette, avoiding the settled material at the bottom of the flasks. All WAFs with loadings were slightly turbid and were filtered through Whatmen GF/C fibre filters to remove non settling suspended material.

Sixteen control replicates and 4 replicates from each test solution were set up. Each replicate received 5 - 8 animals. Dose verification analysis was performed by TOC analysis of the control, 100 and 1000mg/L test solutions at the start of the test. The test was performed in darkness. A test with a reference substance gave a valid result.

Since only minor mortality was observed resulting in < 10% mortality in any of the tested WAFs the highest loading tested resulting in 50% mortality (LL50) is >1000 mg/l.

This study is considered to be acceptable for the risk assessment.