Addition reaction products of conjugated sunflower-oil fatty acids and tall-oil fatty acids with maleic anhydride

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to international guideline(s), GLP-compliant, performed in recognized contract research organization, no restrictions, fully adequate for assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Chemical Substance Control Law 1973, amended 2009 under the reference of YAKUSHOKHATSU No. 1121002, SEIKYOKU No.2 and KANPOKIHATSU No. 021121002 and partially amended 2006 as the joint ordinance of Japanese METI, MHLW and MOE

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: nominal 100 mg/L and control
- Sampling intervals: start and end of the renewal periods
- Sampling method: samples were taken from flasks containing no animals
- Sample storage conditions before analysis: no storage prior to analysis

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fractions (WAFs)
Supersaturated solutions were prepared by dispersing/dissolving the test item into the test medium (ISO Medium) at a nominal concentration of 100 mg/L. This dispersion was shaken for about 24 hours at approximately 30°C and then was equilibrated for about 24 hours at the test temperature. The non-dissolved test material was removed by filtration through a 0.22-µm filter to provide the WAF.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: National Institute of Public Health, 1097 Budapest Gyáli u. 2-6. Hungary. The Daphnia are bred in-house.
- Age at study initiation: < 24 h
- Feeding during test: none

ACCLIMATION
None; the same medium (ISO medium according to the OECD and EC guidelines) was used for breeding and tests. The health of the stock animals is continuously monitored by visual daily checking. Abnormal behavior or significant decrease of population is recorded.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

249 mg/L as CaCO3 (calculated)

Test temperature:

20.8-21.2 °C

pH:

7.70-7.96

Dissolved oxygen:

7.3-7.6 mg O2/L

Nominal and measured concentrations:

nominal loading rate: 100 mg test material/L as WAF
measured concentrations:
in fresh media: 5.6 ± 2.9 and 3.7 ± 1.5 mg test material/L (start of first and second renewal period)
in expired media (24 h): 4.7 ± 2.5 and 6.0 ± 2.9 mg test material/L (end of first and second renewal period)

Details on test conditions:

TEST SYSTEM
- Test vessel: open glass beakers containing approx. 25 mL medium
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: at least 5 mL medium per animal

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised water
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: no
- Intervals of water quality measurement: water temperature, oxygen concentration and pH in the controls and the test solutions were measured at the beginning and at the end of each renewal period.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light and 8-hour dark cycle

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : number of immobilised animals and percentage of immobility at 24 and 48 hours

RANGE FINDING STUDY
- Test concentrations: nominal loading rate of 100 mg/L (WAF) and dilutions 10, 1 and 0.1 mg/L
- Results used to determine the conditions for the definitive study: no immobility after 48 hours

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: results are expressed in terms of loading rates

Details on results:

- Behavioural abnormalities: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- 48-hour EC50: 0.98 mg/L (95% confidence limits. 0.92-1.06 mg/L)

Reported statistics and error estimates:

No statistical analysis was performed because of the lack of toxic effects.
The EC50, NOEC, LOEC and EC100 values were determined directly from the raw data.

Validity criteria fulfilled:

yes

Remarks:

In the control, no Daphnia have been immobilised or trapped at the surface of the water. The dissolved oxygen concentration at the end of the test was > 3 mg/L in control and test vessels.

Conclusions:

The results indicate that the test material is not toxic to daphnia up to the limits of its water solubility.

Description of key information

48-h EL50 (based on loading rates) >100 mg/L for Daphnia magna (OECD 202, EU C.2)

Additional information

LC50 for freshwater invertebrates: > 100 mg/L

The results indicate that the test material is not toxic to daphnia up to the limits of its water solubility and a NOEC and thus a PNEC cannot be determined.