Registration Dossier

Diss Factsheets

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
04 August, 2015 to 28 November, 2015
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Identified as: FAT 36038/J
Appearance: solid, powder, violet colored
Batch no.: 1404301 (China)
Storage: Room temperature in the dark
Analytical monitoring:
yes
Details on sampling:
Not available
Vehicle:
not specified
Details on test solutions:
A range finding experiment was conducted with 0.0001, 0.001, 0.01, 0.1 and 0.88 mg/L and concurrent control group was also maintained.
Based on the results of range finding experiment the concentrations for the main experiment were fixed with a geometric factor of 3.2 the concentrations fixed for the main experiment were 0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L.
Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Species- Pseudokirchneriella subcapitata
- Inoculation: 26300 cells/ml
- Source (laboratory, culture collection): ATCC 22662 (Procured from LGC Promochem India Pvt. Ltd, Bangalore 560 058)
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h
Remarks on exposure duration:
None
Post exposure observation period:
None
Hardness:
No data
Test temperature:
22.5 – 23.8 °C
pH:
8.66 – 9.05
Dissolved oxygen:
Not available
Salinity:
Not available
Nominal and measured concentrations:
0.0001, 0.001, 0.01, 0.1 and 0.88 mg/L (nominal) (pre test)
0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L (main test)
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL conical flask
- Initial cells density: 28475 cells/mL
- Control end cells density: 26300 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: 8.66 – 9.05
- Light intensity and quality: 6780 – 6900 Lux


Reference substance (positive control):
not required
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.16 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.:
0.001 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
0.003 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.29 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.001 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
0.003 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
biomass
Details on results:
The ErC50 of FAT 36038/J TE observed for test period of 72 hours for freshwater alga (Pseudokirchneriella subcapitata) was calculated as 0.16 mg/L.

The EyC50 of FAT 36038/J TE bserved for a test period of 72 hours for freshwater alga (Pseudokirchneriella subcapitata) was calculated as 0.29 mg/L .
Results with reference substance (positive control):
Not available
Reported statistics and error estimates:
Not available
Validity criteria fulfilled:
yes
Conclusions:
The ErC50 and EyC50 of FAT 36038/J TE observed for test period of 72 hours for freshwater alga (Pseudokirchneriella subcapitata) were 0.16 and 0.29 mg/L, respectively.
Executive summary:

A key study was performed to determine growth Inhibition in Freshwater green Algae (Pseudokirchneriella subcapitata) in accordance with OECD-201 guideline with FAT 36038/J TE. The test concentrations were selected as 0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L.

1.0004 g of the test item was dissolved and made up to 1L of OECD medium in a 1L standard flask, ultrasonicated for 15 minutes and then the test dispersion was kept on the magnetic stirrer up to 5 days. The test dispersion that was kept on the magnetic stirrer was removed and allowed to settle down for approximately one hour. Then the test dispersion was filtered through the filter paper and the filtrate was used for the dose formulation, which is supposed to be 0.88 mg/L concentration as per the previous analytical results.Test item was dissolved in OECD medium.

Average Specific Growth Rate:

The percent inhibition on the average growth rate at the end of 72 hour was 0.17 %, 11.36 %, 11.77 %, 26.96 %, 51.63 %, 56.31 % and 68.14 % in test concentration of 0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L respectively.

From the average specific growth rate recorded with the different test concentrationsviz.,0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L the concentration that inhibited 50 % growth (ErC50) of Freshwater green Algae (Pseudokirchneriella subcapitata)was calculated as 0.16 mg/L.

The no observed effect concentration (NOEC) and the lowest observed effect concentration (LOEC) were recorded to be 0.0008 mg/L and 0.003 mg/L respectively.

Yield:

The percent inhibition on the yield at the end of 72 hour was 0.04 %, 5.20 %, 6.15 %, 20.32 % 31.16 %, 43.23 % and 70.79% in test concentrations 0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L respectively.

From the yield recorded with the different test concentrationsviz.,0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L, the concentration that inhibited 50% growth (EyC50) of Freshwater green Algae (Pseudokirchneriella subcapitata)was calculated as 0.29 mg/L.

The no observed effect concentration (NOEC) and lowest observed effect concentration (LOEC) were calculated as 0.0008 mg/L and 0.003 mg/L respectively.

However, FAT 36038/J is a violet colored dye, which can lead to intense discoloration of the test medium during the testing. The discoloration of test medium in algal tests leads to decreasing the amount of light reaching the algae, thereby hampering the photosynthesis process and adversely affecting the algal growth. In the present study, no consideration was given to this point, and hence the study was considered to be lacking on this front and disregarded. Instead a study investigating toxicity to aquatic plants was conduced and taken for consideration.

Description of key information

The ErC50 and EyC50 of FAT 36038/J observed for test period of 72-hour for freshwater alga (Pseudokirchneriella subcapitata) were 0.16 and 0.29 mg/L, respectively. However, FAT 36038/J is a violet colored dye, which can lead to intense discoloration of the test medium during the testing. The discoloration of test medium in algal tests leads to decreasing the amount of light reaching the algae, thereby hampering the photosynthesis process and adversely affecting the algal growth. In the present study, no consideration was given to this point, and hence the study was considered to be lacking on this front and disregarded. Instead a study investigating toxicity to aquatic plants was conducted and taken for consideration.

Key value for chemical safety assessment

Additional information

A key study was performed to determine growth Inhibition in Freshwater green Algae (Pseudokirchneriella subcapitata) in accordance with OECD-201 guideline with FAT 36038/J. The test concentrations were selected as 0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L. At the end of 72 hr exposure time the following results were observed:


Average Specific Growth Rate:


The percent inhibition on the average growth rate at the end of 72 hour was 0.17 %, 11.36 %, 11.77 %, 26.96 %, 51.63 %, 56.31 and 68.14 % in test concentration of 0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L, respectively.


From the average specific growth rate recorded with the different test concentrations viz.,0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L the concentration that inhibited 50% growth (ErC50) of Freshwater green Algae (Pseudokirchneriella subcapitata) was calculated as 0.16 mg/L.


The no observed effect concentration (NOEC) and the lowest observed effect concentration (LOEC) were recorded to be 0.0008 mg/L and 0.003 mg/L ,respectively.


Yield:


The percent inhibition on the yield at the end of 72 hour was 0.04 %, 5.20 %, 6.15 %, 20.32 % 31.16 %, 43.23 and 70.79 % in test concentrations 0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L, respectively.


From the yield recorded with the different test concentrations viz.,0.0008, 0.003, 0.008, 0.03, 0.09, 0.28 and 0.88 mg/L, the concentration that inhibited 50 % growth (EyC50) of Freshwater green Algae (Pseudokirchneriella subcapitata) was calculated as 0.29 mg/L.


The no observed effect concentration (NOEC) and lowest observed effect concentration (LOEC) were calculated as 0.0008 mg/L and 0.003 mg/L, respectively.


The ErC50 and EyC50 of FAT 36038/J TE observed for test period of 72-hour for freshwater alga (Pseudokirchneriella subcapitata) were 0.16 and 0.29 mg/L, respectively.


However, FAT 36038/J is a violet colored dye, which can lead to intense discoloration of the test medium during the testing. The discoloration of test medium in algal tests leads to decreasing the amount of light reaching the algae, thereby hampering the photosynthesis process and adversely affecting the algal growth. In the present study, no consideration was given to this point, and hence the study was considered to be lacking on this front and disregarded. Instead a study investigating toxicity to aquatic plants was conduced and taken for consideration.