Registration Dossier

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:
key study
Study period:
September - October 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
yes
Remarks:
NaHCO3-concentration twice of that indicated in guideline
Principles of method if other than guideline:
The concentration of NaHCO3 was increased to be twice of that indicated in the Guideline 201.
This concentration has been found to be optimal.
GLP compliance:
yes (incl. certificate)
Remarks:
Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material information:
Composition 1
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No test surrogate or analogue material were used.
Analytical monitoring:
yes
Details on sampling:
The supporting TOC analyses at time t0 could not be performed on the same day of collection of the specimens. Therefore, these specimens from freshly prepared test solutions were stored deep-frozen for four days, thawed over-night and then analysed. This represents a deviation of the study plan which is not considered to have an influence on the integrity of the study.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
The test item was introduced into the test solutions as follows: First, suspensions of the test item were individually prepared for each test concentration in ultrapure water and stirred on a magnetic stirrer for 3 min. at room temperature. Thereafter the suspensions were transferred into 10 test vessels, respectively (main test). By the addition of the "intermediate dilution" and the algal inoculation the final nominal concentrations were achieved.
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Common name: Desmodesmus subspicatus CHODAT
- Strain: Strain-No. 86.81
- Source: Sammlung von Algenkulturen, Pflanzenphysiologisches Institut der Universität Göttingen
- Age of inoculum: 3 days
- Method of cultivation: aseptic / sterile conditions

ACCLIMATION
- Culturing media and conditions: same as test
Test type:
static
Limit test:
no
Total exposure duration:
72 h
Post exposure observation period:
No post exposure observation period reported.
Hardness:
No details available.
Test temperature:
24.3 – 25.3 °C
pH:
pH at t0 / pH at t72hr
Control with algal inoculation 7.92 / 9.38 *)
Control without algal inoculation 7.89 / 8.41
2.56 mg/L with algal inoculation 7.90 9.41
2.56 mg/L without algal inoculation 7.89 / 8.38
6.4 mg/L with algal inoculation 7.90 / 9.35
6.4 mg/L without algal inoculation 7.90 / 8.31
16 mg/L with algal inoculation 7.81 / 8.99
16 mg/L without algal inoculation 7.83 / 8.00
40 mg/L with algal inoculation 7.70 / 7.99
40 mg/L without algal inoculation 7.71 / 7.51
100 mg/L with algal inoculation 7.46 / 7.32
100 mg/L without algal inoculation 7.45 / 7.32
*) The difference between t0 and t72hr is 1.46 units and thus fulfills the limits indicated in the guideline.
Dissolved oxygen:
No details available.
Salinity:
No details available.
Nominal and measured concentrations:
nominal concentrations / calculated concentrations:
2.56 / 0.21 mg/L
6.4 / 0.20 mg/L
16 / 0.33 mg/L
40 / 11.35 mg/L
100 / 51.52 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 50 mL-glass cylinders, heat sterilized
- Initial cells density: 2.6*10³ cells/mL
- Control end cells density: 671*10³ cells/mL
- No. of vessels per concentration (replicates): 7
- No. of vessels per control (replicates): 3

GROWTH MEDIUM
- Standard medium used: no
- Detailed composition if non-standard medium was used: OECD-medium, but the final concentration of NaHCO3 was twice as concentrated as indicated in the OECD Guideline 201

TEST MEDIUM / WATER PARAMETERS
- Ultrapure water generating: Purelab Classic D1, USF Seral; Ser.-No. 1470984-10 01 (ELGA Labwater)
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: 72 h
- Light intensity and quality: illumination rate of > 120 µE/m²s ([ca. 8000 Lux] within the range of 400-700 nm)

EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: UV/VIS Spectrophotometer at 578 nm
- Observation intervalls: 0, 21, 45.8 and 72 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.5
- Range finding study
- Test concentrations: 1, 10, 100 and 1000 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
not required
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
24.343 mg/L
Nominal / measured:
nominal
Conc. based on:
other: TOC
Basis for effect:
cell number
Remarks on result:
other: 95%-CL
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
3.17 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: TOC
Basis for effect:
cell number
Remarks on result:
other: 95%-CL
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
208.929 mg/L
Nominal / measured:
nominal
Conc. based on:
other: TOC
Basis for effect:
growth rate
Remarks on result:
other: 95%-CL
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
290.93 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: TOC
Basis for effect:
growth rate
Remarks on result:
other: 95%-CL
Details on results:
As a conclusion of the analytical part of this study, it must be stated that the concentrations of „(benzylamine)trifluoroboron“ decreased by 58.4% up to >99%: After 72 hr at 2.56 mg/L there was a recovery of 0.3% of the initial concentration measured a time t0. At 100 mg/L 51.6 % of the initial concentration was measured after 72 hr.
Based on this, the reported effect concentrations (EC values) should refer to measured concentrations of the test item.
Results with reference substance (positive control):
No reference substance required according to OECD 201.
Reported statistics and error estimates:
Estimation of the inhibition values for yield and the growth rates of the algae as well as the statistical calculations were conducted according to the Guideline using the commercial computer program ToxRatPro Version 2.10.

On the Basis of the nominal Concentrations
[mg „(benzylamine)trifluoroboron“ / L]
  On the Basis of the measured Concentrations
[mg „(benzylamine)trifluoroboron“ / L]
Yield (0 - 72 hr)       Yield (0 - 72 hr)    
  EC50 24.343     EC50 3.170
95%-CL lower 21.403   95%-CL lower 1.983
  upper 27.780     upper 5.346
             
Yield LOEC = 2.560   Yield LOEC = 0.210
  NOEC < 2.560     NOEC < 0.210
         
Growth rate (0 - 72 hr)     Growth rate (0 - 72 hr)  
  EC50 208.929     EC50 290.930
95%-CL lower 155.830   95%-CL lower 141.799
  upper 334.041     upper 1.046.939
             
Growth rate LOEC = 2.560   Growth rate LOEC = 0.210
  NOEC < 2.560     NOEC < 0.210

As a conclusion of the analytical part of this study, it must be stated that the concentrations of (benzylamine)trifluoroborondecreased by 58.4% up to >99%: After 72 hr at 2.56 mg/L there was a recovery of 0.3% of the initial concentration measured at time t0. At 100 mg/L 51.6 % of the initial concentration was measured after 72 hr. Based on this, the reported effect concentrations (EC values) should refer to measured concentrations of the test item.


Validity criteria fulfilled:
yes
Remarks:
The validity criteria for the study as given by the OECD Guideline 201 were met.
Conclusions:
The study is regarded as a valid guideline study with certificated GLP compliance. The reported result for EC50 (growth rate) is 290.930 mg/L.
Executive summary:

The toxicity of „(benzylamine)trifluoroboron“ towards algae was tested according to OECD Guideline No. 201, in the Version dated 23-March-2006. The toxic effect was investigated by determination of the inhibition of the growth rate of the algae and the yield during the exposure period of 72 hours. The following EC-values are assumed:

Yield, nominal concentrations, 95%-CL: EC50 24.343 mg/L (lower 21.403mg/L, upper 27.780 mg/L)

Yield, measured concentrations, 95%-CL: EC50 3.170 mg/L (lower 1.983 mg/L, upper 5.346 mg/L)

Growth rate, nominal concentrations, 95%-CL: EC50 208.929 mg/L (lower 155.830 mg/L, upper 334.041 mg/L)

Growth rate, measured concentrations, 95%-CL: EC50 290.930 mg/L (lower 141.799 mg/L, upper 1046.939 mg/L)

As a conclusion of the analytical part of this study, it must be stated that the concentrations of „(benzylamine)trifluoroboron“ decreased by 58.4% up to >99%: After 72 hr at 2.56 mg/L there was a recovery of 0.3% of the initial concentration measured a time t0. At 100 mg/L 51.6 % of the initial concentration was measured after 72 hr. Based on this, the reported effect concentrations (EC values) should refer to measured concentrations of the test item.

The validity criteria for the study as given by the OECD Guideline 201 were met and the study is therefore considered to be valid. The increase of pH in the control by 1.46 meets the requirements of the Guideline OECD 201.

Description of key information

OECD 201, GLP, Desmodesmus subspicatus, given values based on measured concentrations: 
Effect based on growth rate: ErC50(72h): 290.930 mg/L, NOEC(r): < 0.210 mg/L
Effect based on biomass (yield): EyC50(72h): 3.170 mg/L, NOEC(y): < 0.210 mg/L

Key value for chemical safety assessment

EC50/LC50 for freshwater algae:
290.93 mg/L
EC10, LC10 or NOEC for freshwater algae:
2.425 mg/L

Additional information

The toxicity of „(benzylamine)trifluoroboron“ towards algae was tested according to OECD Guideline No. 201, in the Version dated 23-March-2006. The toxic effect was investigated by determination of the inhibition of the growth rate of the algae and the yield during the exposure period of 72 hours. The following EC-values are assumed:

Yield, nominal concentrations, 95%-CL: EC50 24.343 mg/L (lower 21.403mg/L, upper 27.780 mg/L)

Yield, measured concentrations, 95%-CL: EC50 3.170 mg/L (lower 1.983 mg/L, upper 5.346 mg/L)

Growth rate, nominal concentrations, 95%-CL: EC50 208.929 mg/L (lower 155.830 mg/L, upper 334.041 mg/L)

Growth rate, measured concentrations, 95%-CL: EC50 290.930 mg/L (lower 141.799 mg/L, upper 1046.939 mg/L)

As a conclusion of the analytical part of this study, it must be stated that the concentrations of „(benzylamine)trifluoroboron“ decreased by 58.4% up to >99%: After 72 hr at 2.56 mg/L there was a recovery of 0.3% of the initial concentration measured a time t0. At 100 mg/L 51.6 % of the initial concentration was measured after 72 hr. Based on this, the reported effect concentrations (EC values) should refer to measured concentrations of the test item.

The validity criteria for the study as given by the OECD Guideline 201 were met and the study is therefore considered to be valid. The increase of pH in the control by 1.46 meets the requirements of the Guideline OECD 201.