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Ecotoxicological information

Toxicity to aquatic plants other than algae

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Administrative data

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Endpoint:
toxicity to aquatic plants other than algae
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Test organisms (species):
Lemna minor
Details on test organisms:
- Source : Federal Enviromental Agency (Berlín, Alemania)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
7 d
Test temperature:
24±2ºC
pH:
5.38-6.50
Nominal and measured concentrations:
Concentrations tested (active material): 0.85 mg/L, 2.73 mg/L, 8.54 mg/L, 27.32 mg/L, 85.38 mg/L, 273.2 mg/L and 853.8 mg/L
Actual concentration of the test stock solution (active material): 855.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 150 ml beaker
- Material, size, headspace, fill volume: glass with 100 ml of test medium

GROWTH MEDIUM
- Standard medium used: yes
Test medium with the following composition:
Macroelements
— Solution 1: KNO3 17,5 g/L H2O; KH2PO4 4,5 g/L H2O; K2HPO4 0,63 g/L H2O
— Solution 2: MgSO4 7H2O 5 g/L H2O
— Solution 3: Ca(NO3)2 4H2O 14,75 g/L H2O

Microelements
— Solution 4: H3BO3 120mg/L H2O
— Solution 5: ZnSO4 7H2O 180 mg/L H2O
— Solution 6: Na2MoO4 2H2O 44,0 mg/L H2O
— Solution 7: MnCl2 4H2O 180,0 mg/L H2O
— Solution 8: FeCl3 6H2O 760,0 mg/L H2O
AEDT Na2 2H2O 1500,0 mg/L H2O

Add to 1000 mL of deionized sterile water:
Solution 1 20 mL
Solution 2 20 mL
Solution 3 20 mL
Solution 4 1 mL
Solution 5 1 mL
Solution 6 1 mL
Solution 7 1 mL
Solution 8 1 mL


ILLUMINATION:
Intensity and Quality of light: 6500 Lux
The surface where the test is performed receives uniform fluorescent lighting and continuous (white-cold type).
Reference substance (positive control):
yes
Remarks:
3,5-diclofenol
Key result
Duration:
7 d
Dose descriptor:
EC50
Effect conc.:
1 195 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Duration:
7 d
Dose descriptor:
EC50
Effect conc.:
60.2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
biomass
Results with reference substance (positive control):
The validation criterion considered for this study is:
- the average number of fronds in the control must present a growth rate specific medium of at least 0.275 per day.
- Duplication time of approximately 2.5 days, and multiplication by 7 of the number of fronds, at the end of the study
- The EC50 7d value of 3,5-diclofenol is in the range 2.2 - 3.8 mg / L.
Validity criteria fulfilled:
yes
Conclusions:
The Direct Blue 281 test product (PF12016 G-D) has a value of EC50 (7d ) of inhibition of the growth rate equal to 1195 mg / L and an inhibition value of biomass EC50 (7d) equal to 60.2 mg/L of active material in Lemna minor.
Executive summary:

The study of acute toxicity to aquatic plants of Direct Blue dye 281was carried out.

For the determination of the inhibition of algal growth, the freshwater aquatic plant Lemna minor has been used and the operative method has been followed according to the OECD Guideline 221 (2006).

The freshwater aquatic plant Lemna minor has been subject to the substance at the test concentrations: 0.85 mg/L, 2.73 mg/L, 8.54 mg/L, 27.32 mg/L, 85.38 mg/L, 273.2 mg/L and 853.8 mg/L. The total duration of the trial has been 7 days.

The result obtained in this test indicates that the tested substance has an inhibition value of the growth rate EC50 (7d) equal to 1195 mg / L and an inhibition value of biomass EC50 (7d) equal to 60.2 mg / L of active material after 7 days of testing.

Endpoint:
toxicity to aquatic plants other than algae
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Test organisms (species):
Lemna minor
Details on test organisms:
- Source : Federal Enviromental Agency (Berlín, Alemania)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
7 d
Test temperature:
24±2ºC
pH:
5.38-6.50
Nominal and measured concentrations:
Concentrations tested (active material): 0,92 mg/L, 2,9 mg/L, 9,2 mg/L, 29,3 mg/L, 91,6 mg/L, 293 mg/L y 916 mg/L
Actual concentration of the test stock solution (active material): 918,7 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 150 ml beaker
- Material, size, headspace, fill volume: glass with 100 ml of test medium

GROWTH MEDIUM STEINBERG
- Standard medium used: yes
Test medium with the following composition:
Macroelements
— Solution 1: KNO3 17,5 g/L H2O; KH2PO4 4,5 g/L H2O; K2HPO4 0,63 g/L H2O
— Solution 2: MgSO4 7H2O 5 g/L H2O
— Solution 3: Ca(NO3)2 4H2O 14,75 g/L H2O

Microelements
— Solution 4: H3BO3 120mg/L H2O
— Solution 5: ZnSO4 7H2O 180 mg/L H2O
— Solution 6: Na2MoO4 2H2O 44,0 mg/L H2O
— Solution 7: MnCl2 4H2O 180,0 mg/L H2O
— Solution 8: FeCl3 6H2O 760,0 mg/L H2O
AEDT Na2 2H2O 1500,0 mg/L H2O

Add to 1000 mL of deionized sterile water:
Solution 1 20 mL
Solution 2 20 mL
Solution 3 20 mL
Solution 4 1 mL
Solution 5 1 mL
Solution 6 1 mL
Solution 7 1 mL
Solution 8 1 mL


ILLUMINATION:
Intensity and Quality of light: 6500 Lux
The surface where the test is performed receives uniform fluorescent lighting and continuous (white-cold type).
Reference substance (positive control):
yes
Remarks:
3,5-diclofenol.
Key result
Duration:
7 d
Dose descriptor:
EC50
Effect conc.:
1 087 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Duration:
7 d
Dose descriptor:
EC50
Effect conc.:
112 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
biomass
Results with reference substance (positive control):
The validation criterion considered for this study is:
- the average number of fronds in the control must present a growth rate specific medium of at least 0.275 per day.
- Duplication time of approximately 2.5 days, and multiplication by 7 of the number of fronds, at the end of the study
- The EC50 7d value of 3,5-diclofenol is in the range 2.2 - 3.8 mg / L, value 2.9 mg/L
Validity criteria fulfilled:
yes
Conclusions:
The Direct Blue 281 test product (PF12016 G-D) has a value of EC50 (7d ) of inhibition of the growth rate equal to 1087 mg / L and an inhibition value of biomass EC50 (7d) equal to 112 mg/L of active material in Lemna minor.
Executive summary:

The study of acute toxicity in aquatic plants of Direct Blue dye 281was carried out.

For the determination of the inhibition of algal growth, the freshwater aquatic plant Lemna minor has been used and the operative method has been followed according to the OECD Guideline 221 (2006).

The freshwater aquatic plant Lemna minor has been subject to the substance at the test concentrations: 0,92 mg/L, 2,9 mg/L, 9,2 mg/L, 29,3 mg/L, 91,6 mg/L, 293 mg/L y 916 mg/L. The total duration of the trial has been 7 days.

The result obtained in this test indicates that the tested substance has an inhibition value of the growth rate EC50 (7d) equal to 1087 mg / L and an inhibition value of biomass EC50 (7d) equal to 112 mg / L of active material after 7 days of testing.

Description of key information

There are two studies conducted on the substance Direct Blue 281 (CAS 85136 -25 -0) according to the OECD Guideline 221 to determine the toxicity to aquatic plants Lemna minor. Based on the ECHA guidances, this test method is considered more suitable

for testing toxicity of coloured test materials than the OECD guideline 201 to test the toxicity to aquatic algae.

The EC50 (7d) values 1192 mg/L active ingr. and 1087 mg/L active ingr. obtained in these two studies, show that the tested substance is not harmful to this type of aquatic plant.

Key value for chemical safety assessment

EC50 for freshwater plants:
1 139.5 mg/L

Additional information