D-Mannitol, 1,4:3,6-dianhydro-, 2,5-bis[3-methoxy-4-[[4-[(1-oxo-2-propen-1-yl)oxy]benzoyl]oxy]benzoate]

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (3R,3aS,6R,6aS)-6-[(4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoyl)oxy]hexahydrofuro[3,2-b]furane-3-yl 4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoate and (3R,3aR,6R,6aR)-6-(4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(4-(acryloyloxy)benzoyloxy)benzoyloxy)-3-methoxybenzoate + Isomers and (3R,3aR,6R,6aR)-6-(4-(4-(4-(acryloyloxy)benzoyloxy)-3- methoxybenzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoate + Isomers

IUPAC Name:

Reaction mass of (3R,3aS,6R,6aS)-6-[(4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoyl)oxy]hexahydrofuro[3,2-b]furane-3-yl 4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoate and (3R,3aR,6R,6aR)-6-(4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(4-(acryloyloxy)benzoyloxy)benzoyloxy)-3-methoxybenzoate + Isomers and (3R,3aR,6R,6aR)-6-(4-(4-(4-(acryloyloxy)benzoyloxy)-3- methoxybenzoyloxy)-3-methoxybenzoyloxy)hexahydrofuro[3,2-b]furan-3-yl 4-(4-(acryloyloxy)benzoyloxy)-3-methoxybenzoate + Isomers

Details on test material:

Name: 2MeO3-Im4KA2
Chemical Name: (3R,3aS,6R,6aS)-6-[(4-{[4-(acryloyloxy]benzoyl]oxy}-3-methoxybenzoyl)oxy]hexahydrofuro[3,2-b]furan-3-yl 4-{[4-(acryloyloxy)benzoyl]oxy}-3-methoxybenzoate
Type: Industrial chemical
Aggregate State at Room Temperature:Solid
Colour: Beige
Density: 0.51 g/cm³
Solubility: In water: < 0.1 g/L
Expiry Date: June 30, 2010
Storage: In original container, at room temperature (+10 to +30 °C) in the dark

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
not applicable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Duplicate samples from the only test concentration (without algae) and from the control were taken at the start of the test.
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentration during the test period, duplicate samples from the test medium of the only test concentration and the control (without algae) were taken at the end of the test (after the 72 hours test period).

Test solutions

Vehicle:

no

Details on test solutions:

not applicable

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

Pseudokirchneriella subcapitata, Strain No. 61.81 SAG
cultivated in the testing laboratories ; original source: "Sammlung von Algenkulturen, Pflanzenphysiologisches Institut der Universität Göttingen", 37073 Göttingen, Germany

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

72 h

Remarks on exposure duration:

none

Post exposure observation period:

not reported

Test conditions

Hardness:

0.24 mmol/L (= 24 mg/L) as CaCO3

Test temperature:

23 °C

pH:

8.1 at test start and 8.3 at test end

Dissolved oxygen:

not reported

Salinity:

not reported

Nominal and measured concentrations:

100 mg/l (nominal) limit test

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Erlenmeyer flasks of 50 mL volume with 50 mL of test medium.
- No. of vessels per concentration (replicates):6
- No. of vessels per control (replicates):6

GROWTH MEDIUM
- Standard medium used: yes


TEST MEDIUM / WATER PARAMETERS
Reconstituted Water
(OECD Medium):
Analytical grade salts were added at the following nominal concentrations in deionised water (conductivity <5 µScm-1):
Macro-nutrients:
NaHCO3 50.0 mg/L
CaCl2  2 H2O 18.0 mg/L
NH4Cl 15.0 mg/L
MgSO4  7 H2O 15.0 mg/L
MgCl2  6 H2O 12.0 mg/L
KH2PO4 1.6 mg/L
Trace Elements:
Na2EDTA 2 H2O 100.0 µg/L
FeCl3 6 H2O 64.0 µg/L
MnCl2 4 H2O 415.0 µg/L
H3BO3 185.0 µg/L
Na2MoO4 2 H2O 7.0 µg/L
ZnCl2 3.0 µg/L
CoCl2 6 H2O 1.5 µg/L
CuCl2 2 H2O 0.01 µg/L

OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: Continuous illumination
- Light intensity and quality: 5890 Lux (range5400-6140 Lux)



TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test

Reference substance (positive control):

yes

Remarks:

potassium dichromate twice a year

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: not applicable

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: yield

Remarks on result:

other: not applicable

Effect concentrations 3

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: not applicable

Details on results:

- Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: substance is not soluble in water
- Effect concentrations exceeding solubility of substance in test medium: yes

Results with reference substance (positive control):

For the evaluation of the quality of the algae and the experimental conditions the reference item potassium dichromate p.a. is tested at least twice a year to demonstrate satisfactory test conditions.

Reported statistics and error estimates:

Based on the calculated cell densities, the 72-hour ERC50 and the 72-hour EyC50 (see Definitions), the corresponding EC10 values and where possible their 95 %-confidence limits were calculated by Probit analysis.
For the determination of the 72-hour LOEC and the 72-hour NOEC, the calculated growth rates and yields at each test concentration were tested for significant differences compared to the control values using the Student-t test for growth rate and yield, respectively.
The software used to perform the statistical analysis was ToxRat Professional, Version 2.09, ToxRat Solutions GmbH, 2005

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Substance is not toxic to algae under the conditions used.

Executive summary:

The influence of 2MeO3-Im4KA2 (66.4% pure) on the growth of the freshwater green algae Pseudokirchneriella subcapitata was assessed in a static limit test according to OECD 201. The 72-hour NOEC was determined to be at least the filtrate of nominal 100 mg test item/L. The NOEC might even be higher than this concentration, but concentrations in excess of 100 mg test item/L or the limit of solubility have not been tested according to the recommendations of the test guidelines. The 72-hour LOEC and the 72-hour EC50 were clearly higher than the filtrate of nominal 100 mg test item/L. These values could not be quantified due to the absence of toxicity of 2MeO3-Im4KA2 up to the filtrate of nominal 100 mg test item/L.