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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 June to 2 July 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP Statement
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
n/a
Analytical monitoring:
yes
Details on sampling:
Samples were taken from the control (replicates 1-6 pooled) and each test group (replicates 1-3 pooled) at 0 and 72 hours for quantitative analysis.
Vehicle:
no
Details on test solutions:
For the range finding test:
50 mg of test item was dissolved in culture medium and the volume adjusted to 500mL to give a 100 mg/L stock solution. Dilutions of the stock solution were prepared to give test concentrations of 0.10, 1.0, 10 and 100 mg/L.

200mL aliquots of each solutioon were seperately inoculated with algal suspension (2.0mL) to give these test concentrations.

For the definitive test:
Based on the range-finding test , definitive test concentrations were assigned at 1.0, 3.2, 10, 32 and 100 mg/L.
100 mg of test item was dissolved in culture medium and the volume adjusted to 1000mL to give a 100 mg/L stock solution. Dilutions of the stock solution were prepared to give test concentrations of 1.0, 3.2, 10, 32 and 100 mg/L.

400mL aliquots of each solutioon were seperately inoculated with algal suspension (2.0mL) to give these test concentrations.
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
Species: Desmodesmus subspicatus
Strain: CCAP 276/20
Source: Culture Collection of Algae and Protozoa, Dunstaffnage Marine Laboratory, Oban, Scotland

Culture conditions
Temperature: 24 +/- 1 deg C
Shaking: 100-150 rpm

Culture media: deionised water with minerals added - See study report for details.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Post exposure observation period:
n/a
Hardness:
n/a
Test temperature:
24 +/- 1 deg C
pH:
determined at initiation and after 72 hours, using a WTW pH 320 meter, see table below.
Dissolved oxygen:
n/a
Salinity:
n/a
Nominal and measured concentrations:
Geometric mean of measured concentrations at start and end of test period.
Details on test conditions:
250 mL glass conical flasks were used. Six contol flasks and three replicates of each test concentration were used in the study.
Pre-culture conditions gave an algal suspension in log phase growth characterised by cell density = 7.89 x 10^5 cells/mL. Innoculation of 400mL of the test medium with 2.0mL of this algal suspension gave an initial nominal cell density of 4 x 10^3 cells/mL and had no significant dilution effect on test concentration.

Continuous illumination (approx. 7000 Lux) provided by warm white light (380-730 nm) and constant shaking approx. 150 rpm for 72 hours.

Samples were taken at 0, 24, 48 and 72 hours.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
3.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
6.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
19 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
3.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
12 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
3.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
cell number
Duration:
72 h
Dose descriptor:
EC20
Effect conc.:
3.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
cell number
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
5.3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
cell number
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
3.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
cell number
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
12 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
cell number
Details on results:
See Tables below
Results with reference substance (positive control):
ErC50 (0 -72h) = 0.74 mg/L
EyC50 (0 -72h) = 0.37 mg/L, 95% CI 0.34 - 0.41 mg/L

NOEC (r) = 0.25 mg/L
NOEC (y) = 0.25 mg/L

LOEC (r) = 0.50 mg/L
LOEC (y) = 0.50 mg/L

 Results based on geometric mean of measure concentrations:

Response
Variable

EC50 (mg/L)

NOEC (mg/L)

LOEC (mg/L)

Growth Rate

19

3.4

12

Yield

5.3

3.4

12

 

Table of cell densities and percentage inhibition of growth from the range finding test

Nominal
Concentration (mg/L)

Cell Densities (cells/mL)

Inhibition Values (%)

0 hours

72 hours

Growth Rate

Yield

Control

R1

4.64 E+03

1.90 E+05

-

-

R2

4.49 E+03

2.10 E+05

Mean

4.56 E+03

2.00 E+05

0.10

R1

5.04 E+03

2.84 E+05

[4]

[40]

R2

5.21 E+03

2.73 E+05

Mean

5.12 E+03

2.78 E+05

1.0

R1

4.95 E+03

2.25 E+05

2.0

0.0

R2

4.80 E+03

1.77 E+05

Mean

4.88 E+03

2.01 E+05

10

R1

4.78 E+03

2.74 E+05

55

88

R2

5.17 E+03

3.04 E+05

Mean

4.98 E+03

2.89 E+05

100

R1

5.18 E+03

7.65 E+05

87

98

R2

4.26 E+03

7.86 E+05

Mean

4.72 E+03

7.75 E+05

 

Table of cell densities and pH values in the defnitive test

Nominal
Concentration (mg/L)

pH

Cell Densities (cells/mL)

pH

0 hours

0 hours

24 hours

48 hours

72 hours

72 hours

Control

R1

7.8

4.60 E+03

7.92 E+03

4.30 E+04

1.53 E+05

7.8

R2

7.8

4.56 E+03

8.28 E+03

3.48 E+04

1.68 E+05

7.8

R3

7.7

5.16 E+03

8.30 E+03

3.00 E+04

1.18 E+05

7.7

R4

7.7

4.63 E+03

8.87 E+03

4.23 E+04

2.43 E+05

7.7

R5

7.7

4.42 E+03

9.88 E+03

3.52 E+04

1.35 E+05

7.7

R6

7.6

4.94 E+03

9.30 E+03

3.03 E+04

1.35 E+05

7.6

Mean

 

4.72 E+03

8.76 E+03

3.59 E+04

1.59 E+05

 

1.0

R1

7.6

4.64 E+03

1.37 E+04

5.51 E+04

2.37 E+05

7.6

R2

7.6

4.36 E+03

1.31 E+04

5.55 E+04

3.16 E+05

7.7

R3

7.6

5.10 E+03

1.20 E+04

5.42 E+04

2.89 E+05

7.6

Mean

 

4.70 E+03

1.29 E+04

5.49 E+04

2.80 E+05

 

3.2

R1

7.6

4.70 E+03

9.78 E+03

5.00 E+04

2.51 E+05

7.7

R2

7.6

4.28 E+03

1.23 E+04

5.61 E+04

2.46 E+05

7.6

R3

7.5

4.69 E+03

1.17 E+04

4.98 E+04

2.33 E+05

7.6

Mean

 

4.56 E+03

1.13 E+04

5.20 E+04

2.43 E+05

 

10

R1

7.5

4.88 E+03

5.47 E+03

3.18 E+04

1.48 E+05

7.6

R2

7.5

4.82 E+03

6.50 E+03

2.55 E+04

1.47 E+05

7.6

R3

7.5

4.75 E+03

6.53 E+03

3.58 E+04

1.65 E+05

7.6

Mean

 

4.82 E+03

6.17 E+03

3.10 E+04

1.53 E+05

 

32

R1

7.5

4.48 E+03

6.58 E+03

7.96 E+03

2.33 E+04

7.5

R2

7.4

5.02 E+03

6.22 E+03

1.01 E+04

3.19 E+04

7.4

R3

7.4

4.58 E+03

6.35 E+03

8.56 E+03

2.33 E+04

7.4

Mean

 

4.69 E+03

6.38 E+03

8.87 E+03

2.62 E+04

 

100

R1

7.3

4.53 E+03

4.64 E+03

6.38 E+03

1.89 E+04

7.3

R2

7.2

4.56 E+03

6.66 E+03

6.89 E+03

2.17 E+04

7.3

R3

7.2

4.56 E+03

5.50 E+03

1.18 E+04

2.21 E+04

7.3

Mean

 

4.55 E+03

5.60 E+03

8.37 E+03

2.08 E+04

 

 

Table of inhibition of growth rate and yield in the definitive test

Nominal
Concentration (mg/L)

Growth Rate
 (cells/mL/hour)

Yield
(cells/mL)

0-72 h

% inhib.

0-72 h

% inhib.

Control

R1

0.051

-

1.49 E+05

-

R2

0.052

1.64 E+05

R3

0.047

1.13 E+05

R4

0.057

2.39 E+05

R5

0.049

1.31 E+05

R6

0.049

1.30 E+05

Mean

0.053

1.54 E+05

SD

0.003

4.50 E+04

1.0

R1

0.057

[12]

2.32 E+05

[79]

R2

0.061

[20]

3.11 E+05

R3

0.059

[16]

2.84 E+05

Mean

0.059

[16]

2.76 E+05

SD

0.002

 

4.02 E+04

3.2

R1

0.057

[12]

2.46 E+05

[55]

R2

0.057

[12]

2.42 E+05

R3

0.056

[10]

2.28 E+05

Mean

0.057

[11]

2.39 E+05

SD

0.001

 

9.27 E+03

10

R1

0.050

2

1.43 E+05

4

R2

0.050

2

1.42 E+05

R3

0.052

[2]

1.60 E+05

Mean

0.051

1

1.48 E+05

SD

0.001

 

1.03 E+04

32

R1

0.024

53

1.89 E+04

86

R2

0.029

43

2.69 E+04

R3

0.024

53

1.87 E+04

Mean

0.026

50

2.15 E+04

SD

0.003

 

4.68 E+03

100

R1

0.021

59

1.41 E+04

89

R2

0.023

55

1.71 E+04

R3

0.024

53

1.75 E+04

Mean

0.023

56

1.62 E+04

SD

0.002

 

1.89 E+03

Conclusions:
The 72 hour EC50 of PR-4758 to Desmodesmus subspicatus was calculated using geometric mean measured concentrations at 19 mg/L for growth rate and 5.3 mg/L for yield. The NOEC was 3.4 mg/L and LOEC 12 mg/L for both response variables.
Executive summary:

Study to determine the effect of the test substance on freshwater algae by measuring growth rate and yield, in the presence of different concentrations of the test substance. The method was based on that described in OECD test guideline 201 using the green alga Desmodesmus subspicatus.   

A range finding test and a diffinitive test were completed. In the definitive test, six controls, without test substance, were included in the study along side 3 replicates of each of the five test concentrations which ranged from 1.0 to 100 mg/L. A positive control was carried out using the reference substance potassium dichromate at 5 test concentrations.

The EC50 for the reference substance was 0.74 mg/l, which was within the normal range for the reference item.

The 72 hour EC50 of PR-4758 was calculated using geometric mean measured concentrations at 19 mg/L for growth rate and 5.3 mg/L for yield. The NOEC was 3.4 mg/L and LOEC 12 mg/L for both response variables.

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 June to 5 July 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with international testing guidelines and in accordance with GLP. All relevant validity criteria were met.
Qualifier:
according to guideline
Guideline:
ISO 10253 (Water quality - Marine Algal Growth Inhibition Test with Skeletonema costatum and Phaeodactylum tricornutum)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP Statement
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
n/a
Analytical monitoring:
no
Details on sampling:
n/a
Vehicle:
no
Details on test solutions:
The behaviour of PR-4758 was examined according to the ISO 10253 guideline.
Test solutions were prepared at concentrations of 0, 1, 3, 9 and 27mg/L by dilutions of a stock solution prepared at the highest test concentration.
The stock solution was prepared by dissolving the test substance in the culture medium and mixing for 2-4 hours.

Test organisms (species):
Skeletonema costatum
Details on test organisms:
TEST ORGANISM
Test Species: Skeletonema costatum
Strain: NIVA BAC 1
Algal medium: 1/2 "f" from Guillard and Ryther (1962)
Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
72 h
Post exposure observation period:
n/a
Hardness:
n/a
Test temperature:
18-20.1 deg C
pH:
8.26 - 8.32
Dissolved oxygen:
n/a
Salinity:
n/a
Nominal and measured concentrations:
Nominal concentrations, 0 (control), 1, 3, 9 and 27 mg/L.
Details on test conditions:
Growth inhibition test with marine diatom, 3 parallels at each test concentrationa dn 6 contol parallels. Inhibition was determined by the reduction in growth rate, and cell density was measured with a Turner 10-100 R fluorometer.
The Method was the ISO 10253 standard with supplimentary information obtained from the PARCOM Ring Test in 1991 and in accordance with OSPAR requirements (1995)
Reference substance (positive control):
yes
Remarks:
3, 5-dichlorophenol
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
11 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
18.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC90
Effect conc.:
25.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Details on results:
Growth rate curves were plotted for all the results and ECx values approximated from these graphs.
Results with reference substance (positive control):
One test concentration (1.5 mg/L) of 3, 5-dichlorophenol was analyzed. The growth rate inhibition was 52% after 72h.
Reported statistics and error estimates:
n/a

Test data summary

0 4950 1.82 1.82 +/- 0.00   0 - - -
4800 1.81  
4950 1.82  
4900 1.82  
5000 1.82  
4850 1.81  
1 5100 1.83 1.82 +/- 0.01 -1 -0.4 +/- 0.3 -0.7 -0.1
4950 1.82 0
5000 1.82 0
3 4900 1.82 1.82 +/- 0.00 0 0.0 +/- 0.2 -0.2 0.2
4950 1.82 0
4850 1.81 0
9 4750 1.81 1.81 +/- 0.01 1 0.3 +/- 0.3 0.0 0.6
4900 1.82 0
4850 1.81 0
27 1 -1.01 -1.01 +/- 0.00 156* 155.8* +/- 0.0 155.8* 155.8*
1 -1.01 156*
1 -1.01 156*

* Corresponding to 100% inhibition. Neagtive growth rate gives > 100% inhibition.

Validity criteria fulfilled:
yes
Conclusions:
PR-4758 was found to have an EC50 value for marine algal growth inhibition of 18.3 mg/L after 72 hours, with a NOEC of 9 mg/L.
Executive summary:

Substance: PR-4758

Test Species: Skeletonema costatum, strain NIVA BAC1

Test type: Acute toxicity, 72 hour EC50

Protocol: Static test conditions based on ISO 10253: 1998 "Water quality - Marine Algal Growth Inhibition Test with Skeletonema costatum and Phaeodactylum tricornutum."

There were no significant effects in the control tests and the validation criteria of the positive control reference substance were met.

Marine algal growth inhibition after 72 hours, resulted in EC50 = 18.3 mg/L, and NOEC = 9 mg/L.

Description of key information

72 hour ErC50 (freshwater algae) = 19 mg/L; 72 hour ErC10 (freshwater algae) = 3.2 mg/L; OECD 201; H Vryenhoef (2010)


72 hour ErC50 (marine algae) = 18.3 mg/L; 72 hour ErC10 (marine algae) = 11 mg/L; ISO 10253 (Water quality - Marine Algal Growth Inhibition Test with Skeletonema costatum and Phaeodactylum tricornutum); SI Haug (2002)

Key value for chemical safety assessment

EC50 for freshwater algae:
19 mg/L
EC50 for marine water algae:
18.3 mg/L
EC10 or NOEC for freshwater algae:
3.2 mg/L
EC10 or NOEC for marine water algae:
11 mg/L

Additional information

A key study for both freshwater and marine compartments is available. Both studies were conducted in accordance with international guidelines and GLP.