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Diss Factsheets

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Study undertaken to GLP certification, based on OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
Deviations:
no
Principles of method if other than guideline:
Guideline study
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydroxychloroquine
EC Number:
204-249-8
EC Name:
Hydroxychloroquine
Cas Number:
118-42-3
Molecular formula:
C18H26ClN3O
IUPAC Name:
2-({4-[(7-chloroquinolin-4-yl)amino]pentyl}(ethyl)amino)ethan-1-ol
Test material form:
solid
Remarks:
white solid powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
HYDROXYCHLOROQUINE (CAS N°118-42-3) – Batch 5U054 (Synonym: PLAQUENIL)

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations:
Nominal concentrations were 0.625, 1.25. 2.5, 5, 10 mg/l
Geometric mean concentrations were 0.403, 0.768, 2.064, 4.832, 9.553 mg/l

- Sampling method:
A Hydroxychloroquine quantification was performed according to the validated analytical method to determine the concentration of test item at T0 and T72h in the test for all tested concentrations

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A stock solution of test item was prepared by dissolution of the test item in the test media.

Test organisms

Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Common name: Green algae
- Source (laboratory, culture collection) Culture lab:
- Age of inoculum (at test initiation): 4 days

Study design

Test type:
static
Water media type:
freshwater
Remarks:
OECD TG 201 medium
Limit test:
no
Total exposure duration:
72 h
Remarks on exposure duration:
None
Post exposure observation period:
None

Test conditions

Hardness:
No data (OECD TG 201 medium)
Test temperature:
23°C ± 2°C
pH:
7.7 to 8.7
Dissolved oxygen:
No data (OECD TG 201 medium)
Salinity:
Not applicable
Conductivity:
No data (OECD TG 201 medium)
Nominal and measured concentrations:
Nominal concentrations were 0.625, 1.25. 2.5, 5, 10 mg/l
Geometric mean concentrations were 0.403, 0.768, 2.064, 4.832, 9.553 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker of 250mL filled with 100ml of test solution
- Type (delete if not applicable): closed with synthetic wadding
- Initial cells density: 5.18 * 10^3 cells/ml
- Control end cells density: 1.058 * 10^6 cells/ml
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6

GROWTH MEDIUM
- Standard medium used: yes (OECD TG 201)

OTHER TEST CONDITIONS
- Photoperiod:constant illumination
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2Cr2O7)

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
3.11 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
1.83 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks:
yield
Key result
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
1.83 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.:
0.84 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks:
yield
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.768 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.:
0.768 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks:
yield
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
2.06 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.:
2.06 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks:
yield
Details on results:
- Exponential growth in the control (for algal test): yes
Results with reference substance (positive control):
- Results with reference substance valid? Yes
Potassium dichromate (K2Cr2O7) concentration 0.92 - 1.46 mg/l
72 hour EC50: 1.01 mg/l
Reported statistics and error estimates:
Endpoints and confidence limits were obtained by calculation of ECx according to Regtox® Macro (“Vindimian”) using the Hill model. NOEC and LOEC were estimated by statistic comparison using Statgraphics® software. Data homoscedasticity was checked by Levene test and data were compared by ANOVA.
Tukey HSD test (Honestly Significant Difference. with p < 0.05) was used for pairwise comparisons of several treatment groups.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The reliable (Klimisch 1) OECD 201 Guideline study on algal growth inhibition reported a 72-hr EC50 of 3.11 mg/l and an EC10 of 1.83 mg/L based on growth of Pseudokirchneriella subcapitata (measured geometric mean).
Executive summary:

The reliable OECD 201 Guideline algal growth inhibition study was undertaken to GLP standards. Ecotoxicity test results were based on geometric mean of measured concentrations


Results according to OECD 201 test guideline:

















































  HYDROXYCHLOROQUINE
 Growth inhibition BPL15-0032.001

ErC50-72h


Confidence limits 95%



3.11 mg/L 


(2.96 – 3.27 mg/L)



ErC10-72h


Confidence limits 95%



1.83 mg/L


(1.70 – 1.98 mg/L)



 NOEC



 0.768 mg/L



 LOEC



 2.06 mg/L



Inhibition of yield 



 



 EyC50-72h


Confidence limits 95%



1.83 mg/L


(1.45 – 2.26 mg/L)



EyC10-72h


Confidence limits 95%



 0.840 mg/L


(0.489 – 1.59 mg/L)



 NOEC



 0.768 mg/L



 LOEC



 2.06 mg/L



 


ErC50-xh: Effective Concentration corresponding to 50% of growth inhibition.


ErC10-xh: Effective Concentration corresponding to 10% of growth inhibition.


EyC50-xh: Effective Concentration corresponding to 50% of yield inhibition.


EyC10-xh: Effective Concentration corresponding to 10% of yield inhibition.


NOEC: No Observed Effect Concentration.


LOEC: Lowest Observed Effect Concentration.