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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-12-13 - 2012-12-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Amides, C12-18 (even numbered), N-[3(dimethylamino)propyl], N'-oxides
- identifiers: EC 268-938-5, CAS 68155-09-9
- Molecular formula (if other than submission substance): not stated
- Physical state: nearly colourless (pale yellowish), clear liquid
- Analytical purity: UVCB with 35.8% active ingredient in water
- Lot/batch no.: ST02496002
- Expiration date of the lot/batch: April 2014
- Stability under test conditions: unknown in aqueous solution
- Storage condition of test material: keep in closed containers at room temperature
- Density: 0.908 kg/m³ (20°C)
- Solubility: 1.05g/L (critical micelle concentration 0.941 g/L)
- Boiling point: 126.4 °C
Analytical monitoring:
yes
Details on sampling:
- Sampling method: The day 0 samples are taken directly from the vials of the stock solutions. To the other sampling times (day 1, day 2 and day 3) sampling is performed as follows: Sampling is performed using glass pipettes directly from the test vials. The pipette and all used vials are preconditioned two times with about 2 mL each of the respective test solutions. Then about 1.5 mL of the test sample is taken.
The vials are centrifuged for 10 min at 13.000 rpm (Thermo Scientific Heraeus Fresco 17) to separate the algae. Then 1000 µL of the aqueous sample (or aliquots; or aliquots adjusted to 1000 µL with pure water) and 100 µL of methanol are pipetted into a HPLC vial with screw cap. The vial is closed, shaken shortly by hand and measured by LC-MS/MS. If the concentrations are too high, new diluted samples are prepared and measured. Each centrifuged algae sample is extracted with 500 µL of methanol to determine the residual amount of the test item (respective homologues) sticking to the algae. After short mixing (IKA Vortex-Schüttler VF2) the samples are centrifuged again. Then 100 µL of the methanolic sample and 1000 µL pure water are pipetted into an HPLC vial with screw cap. The vial is closed, shaken shortly by hand and the sample measured by LC-MS/MS.
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: Chlorophycea, Chlorophyta
- Source (laboratory, culture collection): SAG, Culture Collection of Algae at Pflanzenphysiologisches Institut of the University at Göttingen, Albrecht von Haller Institut, Untere Klarspüle 2, D37073
Göttingen, Catalog No 61.81 SAG
- Age of inoculum (at test initiation):
- Method of cultivation: The stock cultures are maintained fulfilling the criteria of the OECD 201 guideline. Prior to testing a pre-culture will be established in standard OECD growth medium to obtain exponentially-growing algae for the test.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Hardness:
not stated
Test temperature:
22°C
pH:
7.2-7.9
Dissolved oxygen:
not stated
Salinity:
not stated
Nominal and measured concentrations:
A non-GLP range-finder test was performed with 3 nominal concentrations and chemical analysis: Control, 0.1, 1.0, and 10.0 mg test item/L.
Nominal concentrations for the definitive test: 0.625, 1.25, 2.50, 5.0 and 10.0 mg test item/L.
At test start, the measured test concentrations, based on the sum of the item fractions, were 0.610, 1.18, 2.24, 4.55 and 9.00 mg/L (i.e. 89.6– 97.6 % of nominal). By test end (72 hours), the measured test concentrations were 0.343, 0.723, 1.49, 3.34 and 7.31 mg/L (i.e. 54.9 – 73.1 % of nominal).
Details on test conditions:
TEST SYSTEM
- Test vessel: sterile 250 mL conical glass flasks covered with air-permeable silicone-sponge caps.
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume:
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- Initial cells density:
- Control end cells density:
- No. of organisms per vessel:
- No. of vessels per concentration (replicates):
- No. of vessels per control (replicates):
- No. of vessels per vehicle control (replicates):

GROWTH MEDIUM
- Standard medium used: yes
- Detailed composition if non-standard medium was used: /

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod:
- Light intensity and quality: The culture vessels were continuously illuminated with a light intensity (day light: OSRAM “cool white”) adjusted to 4440 - 8880 lux close to the surface of the liquid (equivalent to 60-120 µE m-² s-²).
- Salinity (for marine algae): not applicable

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: electronic particle counter (CASY 1 Model TT, Roche Diagnostics GmbH, Germany).
- Chlorophyll measurement:
- Other:

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations: The test concentrations were: control, 0.036, 0.358 and 3.58 mg a.s./L, corresponding to 0.1, 1.0, and 10.0 mg test item/L.
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
3,5-dichlorophenol
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
1.97 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 1.8 - 2.2
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.705 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks on result:
other: 0.63 - 0.79
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.85 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth rate
Key result
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.303 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Details on results:
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: There was a concentration-dependant inhibition on the growth rate and the cell number increase (yield) of P. subcapitata. The inhibition of growth rate was -3.0, 7.7, 51.1, 70.7 and 97.3 % after 72 hours exposure at the test concentrations of 0.405, 0.845, 1.66, 3.64 and 7.95 mg/L (geometrical mean measured concentrations), respectively
Results with reference substance (positive control):
- EC50: The nominal ErC50 value of 2.91 mg/L (95 % confidence limits 2.35 - 3.63 mg/L) is in good agreement with the results of an international ring test with ErC50 of 3.38 ± 1.30 mg/L.
Reported statistics and error estimates:
Yield data showing inhibitions around 50% was statistically analysed to determine an EC50, EC20 and EC10 values together with 95% confidence intervals using Probit-analysis assuming log-normal distribution of the values. Individual replicate responses were used for the regression analysis.
The NOEC and LOEC values for growth rate and yield were determined using the Williams t-test. The computer program ToxRat Professional was used for all statistical evaluations.
Validity criteria fulfilled:
yes
Conclusions:
The mean measured EC50 for growth rate and yield was determined to be 0.705 mg a.i./L and 0.376 mg a.i./L, respectively. A mean measured NOEC of 0.303 mg a.i./L was statistically estimated for growth rate.
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1999-12-06 - 1999-12-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name (as cited in study report): N-(3-N,N-dimetylainooxidetrimetylene)alkylamide
- Code name: NINOX HCDO
- Purity: 92%
- Lot/batch no.: 876 TK Sample IX
- Expiration date of the lot/batch: not stated
- Storage conditions of test material: dark place at room temperature
Analytical monitoring:
yes
Details on sampling:
- Concentrations: algae were exposed to an aqueous solution of the test material at concentrations of 2.0, 4.0, 8.0, 16 and 32 mg a.i./L (3 replicates per conc.) for 72 hrs under constant illumination ans shaking
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water samples were taken from the control and each test group at 0 and 72 hours for quantitative analysis. Duplicate samples were taken at 0 hours and stored frozen for further analysis.
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Common name: Scenedesmus subspicatus
- Strain: CCAP 276/20
- Source: obtained from the Culture Centre for Algae and Protozoa (CCAP), Institute of Freshwater Ecology, Ferry House, Ambleside, Cumbria

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Hardness:
not stated
Test temperature:
24±1°C
pH:
0 hours: 7.5
72 hours: 8.3 - 8.5
Dissolved oxygen:
not stated
Salinity:
not stated
Nominal and measured concentrations:
range-finder: nominal concentrations of 1.0, 10 and 100 mg a.i./L
definitive study: 2.0, 4.0, 8.0, 16, 32 mg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 ml glass conical flasks
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume:
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- Initial cells density: 8.24 x 100,000 cells per ml
- Control end cells density: 10,000 cells per ml
- No. of organisms per vessel:
- No. of vessels per concentration (replicates): 3 flasks each containing 100 ml solution


GROWTH MEDIUM
- Standard medium used: yes
- Detailed composition if non-standard medium was used:


OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Light intensity and quality: continuous illumination (in approx. 7000 lux)


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter]: using a Coulter Multisizer II Particle Counter


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: /
- Range finding study
- Test concentrations: 1, 10 and 100 mg a.i./L
- Results used to determine the conditions for the definitive study: yes
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
4.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks on result:
other: 19-24
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
1.25 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Validity criteria fulfilled:
yes
Conclusions:
Given the decline in measured test concentrations it was considered justifiable to base the results on the time-weighted mean measured test concentrations in order to give a "worst-case" analysis of the data. Following the recommendations of the competent authorities in the EC, in cases where the required test concentration was less than the LOQ, a value of half the LOQ was used for calculating the time weighted mean measured test concentration. The EC50 (72) based on time-weighted mean measured test concentrations was 2.3 mg a.i./L and the ErC50 (0-72h) was 4.5 mg a.i./L. The NOEC was 1.25 mg a.i./L.
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1996-09 -1996-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test substance: Aminoxid WS 35
- identifiers: EC 268-938-5, CAS 68155-09-9
- Chemical characterisation: Fatty acid-aminoalkyldimethylaminoxid - aqueous solution with 35% active matter
- Batch no.: 571003
- Storage conditions: room temperature
- Expiry date: April 1997
- Chemical stability in water: stable
- Stability under test conditions: supporting analysis study was performed
Analytical monitoring:
yes
Details on sampling:
samples to be analyzed were stored deep frozen and protected from light until analysis was performed. Sample collection at start and after 24, 48 and 72 h.
Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Strain: CHODAT, Srain-No. 86.81
- Source: Culture Collection of Algae (SAG), University of Göttingen
- Method of cultivation: Algae were held in a stockculture according to a seperate SOP


Test type:
static
Water media type:
freshwater
Total exposure duration:
72 h
Test temperature:
25 +- 1°C
Nominal and measured concentrations:
Control, 8, 16, 32, 63, 125, 250 and 500 mg a.i./l
Details on test conditions:
TEST SYSTEM
- Initial cells density: 1 x 10^4 cells/ml
- Control end cells density: 96 x 10^4 cells/ml
- No. of vessels per concentration (replicates): 4 + 1 without algae
- No. of vessels per control (replicates): 4 + 1 without algae


TEST MEDIUM / GROWTH MEDIUM
- Standard medium used: yes, according to OECD 201


OTHER TEST CONDITIONS
- Photoperiod: 24h
- Light intensity and quality: ca. 8,000 lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: For quantification of the biomass the extinction of the test solutions measured at 578 nm was used


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: no
Reference substance (positive control):
no
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
53.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 95% CL: 34.5-72.2 mg/l
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
18.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
341 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 95% CL: 287-423 mg/l
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
119.5 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC10
Effect conc.:
25.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: 95% CL: 17.8-32.6 mg/l
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
132 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: 115-152 mg/l
Details on results:
Results for inhibition of growth rate and biomass production as reported in the study report:
72h-ErC50 = > 500 mg test item/l
72h-ErC10 = 180 mg test item/l

72h-EbC50 = 110 mg test item/l
72h-EbC10 = 28 mg test item/l

72h-NOEC = 16 mg test item/l (value directly taken from the nominal concentrations being tested)
Further details see 'Remarks on results'
Reported statistics and error estimates:
Calculation of biomass production and growth rate according to guideline. NOEC resulted directly from the concentrations being tested.

Results as reported in the study report:

Numbers of cells [x 10^4 /ml]

Nominal concentration

[mg test item/l]

24 h

48 h

72 h

Inhibition biomass

[%]

Inhibition growth rate

[%]

Control

11.9

26.9

96.4

100

100

500

5.1

7.4

7.2

93.5

19.1

250

13.6

11.3

11.8

73.8

15.4

125

13.8

15.1

31.1

55.8

8.3

63

12.0

19.3

57.5

35.5

3.8

32

12.2

21.7

86.8

12.7

0.8

16

14.9

23.1

95.4

1.6

0.1

8

13.1

26.9

98.0

-2.6

-0.1

Subsequent calculation of the inhibition of growth rate and biomass production

Remark: A subsequent calculation of the inhibition of growth rate and biomass production was done and is presented in the following table:

subsequent calculation:

Nominal concentration

[mg/l]

Inhibition biomass (0-72h)

[%]

Inhibition growth rate (0-72h)

[%]

Control

100

100

500

83.9

56.9

250

66.5

46.0

125

50.3

24.7

63

31.9

11.3

32

11.4

2.3

16

1.5

0.2

8

-2,3

-0.3

Because of the difference in the results of growth rate inhibition compared to the data presented in the study the ECx-values were re-calculated with ToxRatStd Version 2.09 (demo-version) using probit analysis:

72h-ErC50 = 341 mg/l (95% CL: 287 -423 mg/l)

72h-EbC50 = 132 mg/l (95% CL: 115 -152 mg/l)

These results are considered to be relevant for assesment.

Results of analytical monitoring:

The concentrations were within 100% +- 20% of nominal concentration at test start and test termination. Therefore the effect values are reported as nominal concentrations.

Validity criteria fulfilled:
yes
Conclusions:
In an acute toxicity study according to OECD 201 with Desmodesmus subspicatus a 72h-EC50-value of 341.8 mg test item/l was calculated. The test substance Aminoxide WS 35 is of low toxicity to algae.
Executive summary:

In a 72 hour toxicity study, the cultures of Desmodesmus subspicatus (reported as Scenedesmus subspicatus) were exposed to Aminoxid WS 35 at nominal concentrations of 0, 6, 16, 32, 63, 125, 250 and 500 mg test item/l under static conditions in accordance with the OECD TG 201. The EC10 and EC50 values based on growth rate were 53.5 and 341.85 mg test item/l, respectively.

This study is classified as reliable without restriction and satisfies the guideline requirements of the OECD TG 201.

Results Synopsis

Test Organism: Desmodesmus subspicatus
Test Type: Static

Growth rate:
72-hr ErC10: 53.6 mg test item/l
72-hr ErC50: 341 mg test item/l

Biomass:
72-hr EbC10: 25.2 mg test item/l
72-hr EbC50: 123 mg test item/l

Taking into account the 35% active ingredient in the test item, these values can be recalculated to ErC50 of 119.5 mg a.i./l, ErC10 of 18.8 mg a.i./l and a NOEC of 5.6 mg a.i./l.

Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
9 to 12 July 2007
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
no analytical verifications
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:
- Name of test material (as cited in study report): Empigen OS/A
- Molecular formula (if other than submission substance): R-CO.NH-(CH2)3-N(CH3)2-O where R=CH3-(CH2)y, y=7-17 (predominantly 11-17), linear
- Physical state: yellow liquid
- Analytical purity: 30.07%
- Lot/batch No.: BL 3780
- Storage condition of test material: stored in the dark, at ambient temperature
Analytical monitoring:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 2000 ml volume of the 10 mg/L highest nominal test concentration of Empigen OS/A was prepared by the direct addition of test substance to sterile culture medium. This solution was ultrasonicated for 5 min. and stirred for 30 min. using a PTFE coated magnetic stirring bar. 1000 ml volumes of all lower concentration test solution were prepared by the addition of aliquots of the nominal 10 mg/L test solution to sterile medium. The control consisted of culture medium only.
Using aseptic techniques, 100 ml volumes of the appropriate test solution were dispensed to each test and blank vessel, with the remainder of the test solutions being used for the analyses.
Test organisms (species):
Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:
TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: green alga
- Source (laboratory, culture collection): Brixham Environmental Laboratory culture from strain ATCC 22662
- Age of inoculum (at test initiation): 3 days old
- Method of cultivation:

ACCLIMATION
- Acclimation period:
- Culturing media and conditions (same as test or not):
- Any deformed or abnormal cells observed:
Test type:
static
Water media type:
freshwater
Total exposure duration:
72 h
Hardness:
not stated
Test temperature:
22±2°C
pH:
start of test: 7.5-7.6
end of test: 7.4-7.8
Dissolved oxygen:
not stated
Salinity:
not stated
Nominal and measured concentrations:
culture medium control and nominal concentrations: 0.078, 0.16, 031, 0.63, 1.3, 2.5, 5.0 and 10 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: borosilicate glass conical flasks of 250 ml nominal capacity closed with polyurethane foam bungs. Each flask contained 100 ml test solution.
- No. of vessels per concentration (replicates): triplicate cultures of each concentration of Emipigen OS/A
- No. of vessels per control (replicates): 6 replicate cultures of the culture medium control and triplicate cultures of each concentrations
- No. of vessels per vehicle control (replicates):

GROWTH MEDIUM
- Standard medium used: yes
- Detailed composition if non-standard medium was used: /


OTHER TEST CONDITIONS
- Light intensity and quality: continuous cool white illumination of approx. 6000 lux, with orbital shaking at 160 rpm in a Gallenkamp type INR-401 orbital incubator

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter] electronic particle counting using a Coulter counter model Z1, counting at a lower threshold equivalent spherical diameter of approx. 2.3 µm. Each replicate test vessel was inoculated with 0.445 ml of the inoculum culture to give a nominal cell particle density of 0.5 X 10000 per mL. Three 100 ml volumes of Coulter electrolyte, inoculated in the same manner had a mean measured cell density of 0.52 X 10000 cell particles per mL.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2 (0.078, 0.16, 0.31, 0.63, 1.2, 2.5, 5.0, 10 mg/L)
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.63 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 3.4-3.5
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
0.19 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks on result:
other: NA
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
3.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: 3.3-3.5
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
1.04 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth rate
Remarks on result:
other: NA
Details on results:
- Observation of abnormalities (for algal test): the microscopic observations, made at the end of the test, showed that, compared to the control, the algal cells sampled from the nominal 0.078, 0.16, 0.31 and 0.63 mg/L test concentrations appeared normal. At 1.0 mg/L, a mixture of normal, small and deformed cells observed. No normal cells were observed at the 2.5, 5.0 and 10 mg/L test concentrations. At 2.5 mg/L, small and deformed cells were observed. The abnormalities observed at 5.0 and 10 mg/L were small, deformed and enlarged cells, plus some exhibiting ruptured cell walls. Very low cell numbers were visible at 5.0 and 10 mg/L
Validity criteria fulfilled:
yes
Conclusions:
The results obtained from statistical analysis, and based on nominal concentrations, were as follows:
NOEC = 0.31 mg/L
LOEC = 0.63 mg/L
ErC50 = 3.4 mg/L

Description of key information

One study (Wenzel, 2013) investigating the toxicity of the substance to algae according to OECD guideline 201, was considered as the key study for endpoint coverage. The 72h-ErC50 and 72h-NOEC for growth rate were determined to be 0.705 mg a.i./L (confidence limits of 0.6-0.8 mg a.i./L) and 0.303 mg a.i./L respectively. The study is given a Klimisch score of 1 and was conducted under GLP.

Key value for chemical safety assessment

EC50 for freshwater algae:
0.705 mg/L
EC10 or NOEC for freshwater algae:
0.303 mg/L

Additional information

Four studies investigating the toxicity of the substance to algae according to the OECD guideline 201 are available.


 


The study of Wenzel (2013) is selected as key study for endpoint coverage. The 72h-ErC50 and 72h-NOEC for growth rate were determined to be 0.705 mg a.i./L (confidence limits of 0.6-0.8 mg a.i./L) and 0.303 mg a.i./L respectively. The study is given a Klimisch score of 1 and was conducted under GLP.


 


The studies of Mead (2000) and Kamp (1997) were both conducted under GLP and are assigned a Klimish score of 1. The first study (Mead, 2000) resulted in a 72h-ErC50 of 4.5 mg a.i./L and a 72h-NOErC of 1.25 mg a.I./L. Te second study (Kamp, 1997) resulted in a 72h-ErC50 of 119.5 mg a.i./L and a 72h-ErC10 of 18.8 mg a.i./L. Both studies are selected as supporting studies.


 


Finally, the study of Webley (2008) resulted in a 72h-ErC50 of 1.04 mg a.i./L and a 72h-NOErC of 0.19 mg a.i./L. However, the study was assigned a Klimisch score of 3 as no analytical verification of the tested concentrations was carried out.