Registration Dossier

Ecotoxicological information

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
Study period:
July 30, 2010 - December 07, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Batch: E09000602

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
The test medium (reconstituted water and test material) was freshly prepared. The calibrated flask with test material and vehicle, reconstituted water, was treated in an ultrasound bath for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the preparation was filtered through a filter funnel with a pore size of 10-16 µm. The filtrate was used for the study.

Test organisms

Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
The test system used for this study was a green unicellular algae species, Desmodesmus subspicatus, strain No. SAG 86.81, supplied by the "Sammlung von Algenkulturen, Pflanzenphysiologisches Institut der Universität Göttingen". This strain is recommended by international guidelines.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h

Test conditions

Hardness:
250 mg CaCO3
Test temperature:
22-23°C
pH:
start of exp.: 7.9
end of exp.: 8.8
Dissolved oxygen:
saturated
Salinity:
for details see composition of reconstituted water "details on test conditions"
Nominal and measured concentrations:
Nominal concentration of 100 mg/L (limit test); due to very low water solubility and the fact that the study was a limit test, no further analysis was initiated.
Details on test conditions:
The test medium (reconstituted water and test material) was freshly prepared.
The experimental part was started by inoculation of algae to the different groups so that the flasks contained about 10,000 cells/mL.
The algae were taken from an exponentially growing pre-culture (growth rate 58.3) which was set up 3 days prior to the experimental part under the same conditions as in the final study.
Details on composition of the reconstituted water:

Macro-nutrients:
50.00 mg/L NaHCO3
18.00 mg/L CaCl2 x 2 H2O
15.00 mg/L NH4Cl
15.00 mg/L MgSO4 x 7 H2O
12.00 mg/L MgCl2 x 6 H2O
1.60 mg/L KH2PO4

Trace elements:
100.00 µg/L Na2EDTA x 2 H2O
80.00 µg/L FeCl3 x 6 H2O
415.00 µg/L MnCl2 x 4 H2O
185.00 µg/L H3BO3
7.00 µg/L Na2MoO4 x 2 H2O
3.00 µg/L ZnCl2
1.50 µg/L CoCl2 x 6 H2O
0.01 µg/L CuCl2 x 2 H2O

The pH of the reconstituted water after aeration is approximately 8-9.
Reference substance (positive control):
yes
Remarks:
potassium dichromate from separate study

Results and discussion

Effect concentrationsopen allclose all
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Results with reference substance (positive control):
Regularly, a positive control test to check the test system is carried out with potassium dichromate (no results provided in the study report).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
An aqueous preparation of 100 mg/L (nominal) of the test material revealed no toxic effect in the test system. Analytically, the 72 hours EC50 to Desmodesmus subspicatus could not be determined; it exceeded the maximum solubility of the test material in reconstituted water.