(3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diyl bis(4-hydroxybenzoate)

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:

11 Jul 2004 to 14 Jul 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April, 1984

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

December, 1992

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Public Draft, April 1996

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Version / remarks:

1989

Qualifier:

according to guideline

Guideline:

other: ISO/DIS 10706 Water quality - Determination of long term toxicity of substances to Daphnia magna STRAUS

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Appearance: White solid
- Water-solubility: 29 mg/L (20°C)
- Homogeneity: homogeneous
- Storage conditions: ambient

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 (control), 12.5, 25, 50 and 100 mg/L
- Sampling method: At the begin (after 0 h) samples from vessels without daphnids and at the end of the exposition (after 48 h) samples from vessels with daphnids were analysed.
- Sample storage conditions before analysis: ambient (samples were analysed at the sampling date)

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Preparation of the stock solution: The test substance was stirred in M4 medium tor about 20 hours at 20 ± 2 °C. Undissolved test substance was removed by filtration with a membrane filter (pore width 0.2 µm). The filtrate was a clear and colourless test solution. The concentration of the stock solution was 200.1 mg/2L.
- Preparation test solutions: By diluting this filtrate of the stock solution with M4 medium the test solutions were prepared.
- Controls: M4 medium

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously inhouse.
- Age of the animals at the begin of exposure: 2 - 24 h (starting with the 3rd breed of parent animals)
- Age of stock animals: 2 - 4 weeks
- Feeding during test: None

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.43 mmol/L (total hardness)

Test temperature:

20.0 - 20.4 °C

pH:

8.0 - 8.2

Dissolved oxygen:

8.4 - 9.0 mg/L

Conductivity:

606 µS/cm

Nominal and measured concentrations:

- Nominal concentrations: 0 (control), 12.5, 25, 50 and 100 mg/L (based on a range-finding test)
- Measured concentrations (t = 0h): n.d., 2.94, 5.88, 11.63, 21.9 mg/L
- Measured concentrations (t = 48h): n.d., 2.81, 5.68, 11.21, 22.6 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Test tubes (glass) with flat bottom (nominal volume 20 mL)
- Test volume: 10 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 0.5 animals/mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: A synthetic fresh water (M4 medium) was used for culture and test purposes.
- Total hardness: 2.20 - 3.20 mmol/L
- Alkalinity up to pH 4.3: 0.80 - 1.00 mmol/L
- Molar ratio Ca:Mg: about 4:1
- pH-value: 7.5-8.5
- Conductivity: 550 - 650 µS/cm
- Culture medium different from test medium: No
- Aeration of medium: after preparation the M4 medium is aerated for approximately 24 h until saturation with oxygen is reached.

OTHER TEST CONDITIONS
- Illumination: Artificial light, type warm white (OSRAM L58 W31), day:night rhythm = 16 : 8 h
- Light intensity: About 1 - 8 µEI(m².s) at a wave length of 400 - 750 nm

EFFECT PARAMETERS MEASURED:
- Test parameter: Swimming ability of the test animals; recorded visually after 0, 24 and 48 h
- Other: pH and oxygen were determined at test start and at the end of exposure

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 22.8 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: no effects up to the limit of water solubility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: no effects up to the limit of water solubility

Details on results:

Up to the highest test concentration of 22.8 mg/L (nominal 100 mg/L) no effect on mobility of the daphnids was observed.

Results with reference substance (positive control):

The 24-h EC50 value of the reference substance was 1.41 mg/L.

Reported statistics and error estimates:

No effects on daphnid mobility were observed; no statistics were required to derive the effect concentrations.

Validity criteria fulfilled:

yes

Conclusions:

The test substance is with high probability not acutely harmful to aquatic invertebrates.

Description of key information

The test substance is with high probability not acutely harmful to aquatic invertebrates.

Additional information

The acute toxicity to aquatic invertebrates was determined in a study according to OECD TG 202 and in compliance with GLP criteria. In this study daphnids (D. magna, 20 per concentration) were exposed to dilutions of an aqueous eluate (filtrate) of the test substance stock solution of 100 mg/L, at nominal concentrations of 0 (control), 12.5, 25, 50 and 100 mg/L for 48 hours under static conditions. The mean analytical recovery rate for all test concentrations was 22.8%. Effect concentrations were corrected for the recovery rate. Immobilization was recorded after 24 and 48 hours exposure. No immobilization was observed in the control and test groups. Based on these findings the 48-h EC50 value was determined at > 22.8 mg/L (100 mg/L nominal). The test substance showed no effects up to the limit of water solubility.