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Toxicity to aquatic algae and cyanobacteria

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Reference
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
of read across substance
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two toxicity study of aquatic algae and cyanobacteria for the test chemical :
1. and 2. To evalute algal growth inhibition test of test material
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate
- Molecular formula: C29H36N2O2
- Molecular weight: 444.615 g/mole
- Substance type: Organic
- Physical state: maroon lustrous liquid
Analytical monitoring:
not specified
Vehicle:
not specified
Details on test solutions:
1.The stock solution (10 mg/L) was prepared by dissolving yellow powder in OECD growth medium. Test solutions of required concentration were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture.

2.The test item was prepared by adding 12 mg of test item in 240 ml of BBM to get the final concentration of 50mg/L. This stock solution was kept for stirring for 30 minutes to obtain a homogenous solution for the experiment. The test concentrations were chosen according to the available data of the test item. The remaining test solutions were prepared by dilution from the above stock solution. To have a better growth and visibility of cells, the initial cell density of the culture was kept 1 X 104cells/ml. Care was taken to have a homogeneous solution for the experiment.
Test organisms (species):
other: 1.Desmodesmus subspicatus , 2.Chlorella vulgaris
Details on test organisms:
1.TEST ORGANISM
- Common name:
- Strain: 86.81 SAG
- Source (laboratory, culture collection): Institute of botany of the ASCR
- Initial biomass concentration: 5x10(3) cells /ml
- Method of cultivation: No data available

2.The fresh water green alga Chlorella vulgaris, was used as the test organism. Sterile, unicellular, liquid cultures of algae.
The culture was examined under the microscope to confirm that it was unicellular, healthy and not contaminated.
The medium to be used for the growth of algae was Bold’s Basal Medium (BBM). It is a medium composed of macronutrients, micronutrients, alkaline EDTA solution and Iron solution. Stock solution of each of these was prepared separately and then a complete medium was prepared and sterilized. De-ionized water was used to prepare the BBM.
Test type:
static
Water media type:
freshwater
Total exposure duration:
72 h
Test temperature:
1) 23±2°C
2) 24 °C ±2°C.
pH:
Sample at concentration 0.64 mg/L: pH= 7.9 changed to pH= 7.8 during the test
Control: pH= 8.0 changed to pH= 7.4 during the test
2)6.7 - 7.4
Nominal and measured concentrations:
1) 0, 0.02, 0.04, 0.08, 0.16, 0.32 and 0.64 mg/L.
2) 0.5 mg/l, 1.25mg/l,3.125mg/l, 7.813mg/l, 19.531mg/l and 48.828mg/l
Details on test conditions:
1.TEST SYSTEM
- Test vessel: 50 ml Glass vessel
- Type (delete if not applicable): closed (with air permeable stopper)
- Sample volume: 15 ml
- Initial cells density: 5x10(3) cells/ml
- No. of vessels per concentration (replicates): 3

GROWTH MEDIUM
- Standard medium used: yes

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: Continuous
- Light intensity and quality: 6000-8000 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: microscope with counting chamber Cyrus I or electronic particle counter.
- Other: ErC50 was calculated using non-linear regression by the software Prism 4.0

2.Light Quality White Fluoroscent Light
Light Intensity 1500Lux
Photoperiod 16 Hour Light Period : 8 Hour Dark Period
RPM Speed 120 Revolutions per minute
Water Deionized Waer
Test vessel size 100ml
Test solution volume 60ml
Dilution water Bold’s Basal Medium
Test concentration Six test concentration were:
Replicates per concentration
Three replicates for Control
Two replicates for each test concentration
Reference substance (positive control):
yes
Remarks:
K2Cr2O7
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.13 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 95% CL: 0.11 - 0.15 mg/L
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.61 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
growth rate
Details on results:
2.The microscopic observations were also noted in each of the experimental flasks. All the cells appeared healthy, round and green throughout the test duration in the control and in the experimental flask also no significant changes were observed.
Results with reference substance (positive control):
Results with reference substance valid
- EC50: 0.75 mg/L
Validity criteria fulfilled:
not specified
Conclusions:
The test chemical Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate is likely to be toxic to aquatic allgae and cyanobacteria in the concentration range of 0.13 - 0.61 mg/l
Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate.The studies are as mentioned below:

1.Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the test substance according to OECD Guideline 201.The stock solution (10 mg/L) was prepared by dissolving yellow powder in OECD growth medium. Test solutions of required concentration were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture.

The test substance was dissolved in DMSO/ OECD growth medium and tested at the concentrations 0, 3, 6, 12, 24 and 50 mg/L.Determination of cell concentrations was performed by microscope with counting chamber Cyrus I or electronic particle counter.Effects on the growth rate of the organism were studied. The median effective concentration (EC50) for the test substance, test substance, in Desmodesmus subspicatus was determined to be 0.13 mg/L.

This value indicates that the substance is likely to be hazardous to aquatic algae and can be classified as Aquatic acute category 1 as per the CLP criteria.

2.The effect of test item was studied on the growth of fresh water green algaChlorella vulgaris.The study was conducted following OECD guideline 201- Alga, growth inhibition test. The test concentration chosen for the study were 0.5mg/l, 1.25mg/l, 3.125mg/l, 7.813mg/l, 19.531mg/l and 48.828mg/l. The test concentrations were prepared using stock solution of the test item using mineral media. The green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of the test item. EC50 calculated graphically through probit analysis was observed to be 0.610 mg/L.Thus, based on the EC50 value, test substancecan be considered astoxic to aquatic organisms and thus can be classified as aquatic acute category 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate and it’s structurally similar read across substance, it can be concluded that effect concetration value is in the range of 0.13 - 0.61 mg/

L. Thus, comparing this value with the criteria of CLP regulation Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate can be classified for short term toxicity for aquatic algae and cyanobacteria as "Aquatic chronic 1" .

Description of key information

Toxicity to aquatic algae and cyanobacteria:

Data available for the structurally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate.The studies are as mentioned below:

1.Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the test substance according to OECD Guideline 201.The stock solution (10 mg/L) was prepared by dissolving yellow powder in OECD growth medium. Test solutions of required concentration were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture.

The test substance was dissolved in DMSO/ OECD growth medium and tested at the concentrations 0, 3, 6, 12, 24 and 50 mg/L.Determination of cell concentrations was performed by microscope with counting chamber Cyrus I or electronic particle counter.Effects on the growth rate of the organism were studied. The median effective concentration (EC50) for the test substance, test substance, in Desmodesmus subspicatus was determined to be 0.13 mg/L.

This value indicates that the substance is likely to be hazardous to aquatic algae and can be classified as Aquatic acute category 1 as per the CLP criteria.

2.The effect of test item was studied on the growth of fresh water green algaChlorella vulgaris.The study was conducted following OECD guideline 201- Alga, growth inhibition test. The test concentration chosen for the study were 0.5mg/l, 1.25mg/l, 3.125mg/l, 7.813mg/l, 19.531mg/l and 48.828mg/l. The test concentrations were prepared using stock solution of the test item using mineral media. The green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of the test item. EC50 calculated graphically through probit analysis was observed to be 0.610 mg/L.Thus, based on the EC50 value, test substancecan be considered astoxic to aquatic organisms and thus can be classified as aquatic acute category 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate and it’s structurally similar read across substance, it can be concluded that effect concetration value is in the range of 0.13 - 0.61 mg/

L. Thus, comparing this value with the criteria of CLP regulation Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate can be classified for short term toxicity for aquatic algae and cyanobacteria as "Aquatic chronic 1" .

Key value for chemical safety assessment

EC50 for freshwater algae:
0.61 mg/L

Additional information

Toxicity to aquatic algae and cyanobacteria:

Data available for the structurally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate.The studies are as mentioned below:

1.Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the test substance according to OECD Guideline 201.The stock solution (10 mg/L) was prepared by dissolving yellow powder in OECD growth medium. Test solutions of required concentration were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture.

The test substance was dissolved in DMSO/ OECD growth medium and tested at the concentrations 0, 3, 6, 12, 24 and 50 mg/L.Determination of cell concentrations was performed by microscope with counting chamber Cyrus I or electronic particle counter.Effects on the growth rate of the organism were studied. The median effective concentration (EC50) for the test substance, test substance, in Desmodesmus subspicatus was determined to be 0.13 mg/L.

This value indicates that the substance is likely to be hazardous to aquatic algae and can be classified as Aquatic acute category 1 as per the CLP criteria.

2.The effect of test item was studied on the growth of fresh water green algaChlorella vulgaris.The study was conducted following OECD guideline 201- Alga, growth inhibition test. The test concentration chosen for the study were 0.5mg/l, 1.25mg/l, 3.125mg/l, 7.813mg/l, 19.531mg/l and 48.828mg/l. The test concentrations were prepared using stock solution of the test item using mineral media. The green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of the test item. EC50 calculated graphically through probit analysis was observed to be 0.610 mg/L.Thus, based on the EC50 value, test substancecan be considered astoxic to aquatic organisms and thus can be classified as aquatic acute category 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate and it’s structurally similar read across substance, it can be concluded that effect concetration value is in the range of 0.13 - 0.61 mg/

L. Thus, comparing this value with the criteria of CLP regulation Reaction mass of Ethanaminium, N-​[4-​[[4-​(diethylamino)​phenyl]​phenylmethylene]​-​2,​5-​cyclohexadien-​1-​ylidene]​-​N-​ethyl-​ & acetate can be classified for short term toxicity for aquatic algae and cyanobacteria as "Aquatic chronic 1" .

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