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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Reference
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
Principles of method if other than guideline:
N/A
GLP compliance:
yes
Details on sampling:
Samples of the stock solution and the highest tested concentration at 0 h and 72 h were collected and stored in the freezer until analysed by the sponsor, these results have not been provided for assessment.
Vehicle:
no
Details on test solutions:
20024 mg of the test item was dissolved in 1000 mL growth medium by magnetic stirring on the day of the test start. The test solutions were made by dilution of the stock solution (approx. 20 000 mg/L) with OECD growth medium.
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
The inoculum was taken from Toxicon's culture of P. subcapitata (NIVA CHL 1), which originates from NIVA, Oslo, Norway.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Post exposure observation period:
NA
Hardness:
NA
Test temperature:
21-24°C.
pH:
7.68 to 8.54
Dissolved oxygen:
NA
Salinity:
NA
Nominal and measured concentrations:
Nominal concentrations: Control, 156, 312, 625, 1250, 2500, 5000 and 10000 mg/L
Details on test conditions:
For each test concentration, triplicates were used and for the controls six replicates were used. Test bottles were 250 mL glass E-bottles with 100 mL solution that were incubated on a shaking table with approximately 100 yE m-2 s-1 continuous illumination at a temperature of 21-24±2° C. The pH was measured in the controls and in one replicate of each concentration at the start of the experiment. The pH was again measured in the same replicates after 72 hours. The incubation period was 72 hours with sampling at 0, 24, 48, and 72 hours. As a measurement of the biomass in the samples, the number of cells/ml was counted by microscope.
Reference substance (positive control):
yes
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
1 250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
2 110 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
3 360 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
6 420 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
1 250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Yield
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
1 430 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Yield
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
1 710 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Yield
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
2 660 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Yield
Details on results:
Based on the results presented the most sensitive endpoint was based on yield and therefore for risk assessment purposes the 72 hour EC50 value of 2660 mg/L should be used
Results with reference substance (positive control):
A qualification test on the alga culture was made on the 5th of June 2008 to assure the quality of the test animals. Efi^ was 1,5 mg/1, which confirmed that the culture was suitable as a test organism according to OECD TG no. 201
Reported statistics and error estimates:
NOEC values were calculated using a Mann-Whitney U-test
EC50 values were calculated using graphical interpolation

Samples of the stock solution and the highest tested concentration at 0 h and 72 h were collected and stored in the freezer until analysed by the sponsor. The results of this analysis were not provided at the time of assessment.

Validity criteria fulfilled:
yes
Conclusions:
An EC50-value of 6420 mg/L was found for the response variable average specific growth rate and 2660 mg/L for yield. Since the EC50-value was above 100 mg/L, the test item can be regarded as not acute toxic towards the green algae Pseudokirchneriella subcapitata.
Executive summary:

A 72 hour "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" was performed on the test item Trimethylolpropane oxetane (TMPO) by Toxicon AB, Harslov, Sweden, in July 2008. The test was carried out in accordance with GLP and the OECD Freshwater Alga and Cyanobacteria, Growth Inhibition Test TG no. 201 (2006)

The test organism was a laboratory culture of the green alga Pseudokirchneriella subcapitata. The inoculum was taken from inhouse culturesof P. subcapitata (NIVA CHL 1), which originates from NIVA, Oslo, Norway.

The nutrient concentration in the growth media was the same in all test solutions and in the controls, and the composition was as described in OECD TG 201. For each test concentration, triplicates were used and for the controls six replicates were used. Test bottles were 250 mL glass E-bottles with 100 mL solution that were incubated on a shaking table with approximately 100 uE m-2 s-1 continuous illumination at a temperature of 21-24±2°C. The pH was measured in the controls and in one replicate of each concentration at the start of the experiment. The pH was again measured in the same replicates after 72 hours. The incubation period was 72 hours with sampling at 0, 24, 48, and 72 hours. As a measurement of the biomass in the samples, the number of cells/ml was counted by microscope.

The nominal concentration range used in the test solutions were: 156; 312; 625; 1250; 2500; 5000 and 10000 mg/L.

The effects of the test substance on the growth of algae were determined by two response variables:

a) Average specific growth rate: this response variable is calculated on the basis of the logarithmic increase of biomass during the test period, expressed per day

b) Yield: this response variable is the biomass at the end of the test minus the starting biomass.

The calculated response variables for each treatment group and the control group (mean ± coefficient of variation) after 72 hours exposure for the test item TMPO are presented below:

Nominal Concentration (mg/L) 72 hour mean specific growth rate CV % 72 hour mean yield (cells/mL) CV %
Control 1.53 2.5 1387487 10.8
156 1.47 2.6 1172487 12.1
312 1.49 5.5 1239153 23.0
625 1.54 1.1 1425820 5.1
1250 1.52 3.5 1335820 16.4
2500 1.31 4 719153 16.2
5000 1.05 3.1 322487 10.0
10000 0.04 173 1940 173

Nominal NOEC-value and EC-values (mean values) in mg/L for the two response variables, determined after 72 hours exposure for the test item TMPO. The EC-values was calculated by means of graphic interpolation. The NOEC-value is the highest tested concentration not statistically different from the controls (Mann-Whitney U-test p > 0,05).

The following endpoints were determined:

Endpoint Endpoint (mg/L)
72 h NOEC 72 h EC10 72 h EC20 72 h EC50
Average specific growth rate (ErC50) 1250 2110 3360 6420
Yield (EyC50) 1250 1430 1710 2660

Test guideline validity criteria were achieved.

Description of key information

The 72-hour EC50 was found to be 6240 mg/L based on growth rate and 2660 mg/L based on yield. These values exceed the normal highest dose recommended for such studies (1000 mg/L). Therefore, in the chemical safety assessment performed according to Article 14(3) in connection with Annex I section 3 (Environmental hazard Assessment) no hazard was identified, therefore no PNEC can be derived.

Key value for chemical safety assessment

EC50 for freshwater algae:
2 660 mg/L
EC10 or NOEC for freshwater algae:
1 250 mg/L

Additional information

A 72 hour "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" was performed on the test item 3 -ethyloxetane-3 -methanol (TMPO) by Toxicon AB, Harslov, Sweden, in July 2008. The test was carried out in accordance with GLP and the OECD Freshwater Alga and Cyanobacteria, Growth Inhibition Test TG no. 201 (2006)

Nominal NOEC-value and EC-values (mean values) in mg/L for the two response variables, determined after 72 hours exposure for the test item TMPO. The EC-values was calculated by means of graphic interpolation. The NOEC-value is the highest tested concentration not statistically different from the controls (Mann-Whitney U-test p > 0,05).

The following endpoints were determined:

Endpoint Endpoint (mg/L)
72 h NOEC 72 h EC10 72 h EC20 72 h EC50
Average specific growth rate (ErC50) 1250 2110 3360 6420
Yield (EyC50) 1250 1430 1710 2660

Test guideline validity criteria were achieved.