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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
Study period:
2017-11-21 - 2017-11-24 (experimental phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
Version / remarks:
OECD Guideline for the Testing of Chemicals No. 201, adopted 23. Mar. 2006, Annex 5 corrected: 28 July 2011 “Freshwater Alga and Cyanobacteria, Growth Inhibition Test”
Deviations:
yes
Remarks:
but uncritical, see overall remarks
Qualifier:
according to guideline
Guideline:
EU Method C.3 (Algal Inhibition test)
Version / remarks:
Regulation EU No. 2016/266 amending Regulation EC No. 440/2008, Annex IV, Method C.3: “FRESHWATER ALGAE AND CYANOBACTERIA, GROWTH INHIBITION TEST,” adopted 07. December 201
Deviations:
yes
Remarks:
but uncritical, see overall remarks
Qualifier:
according to guideline
Guideline:
other: OECD guidance document no. 23, GUIDANCE DOCUMENT ON AQUATIC TOXICITY TESTING OF DIFFICULT SUBSTANCES AND MIXTURES, adopted 14. Dec. 2000
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(3-sulphonatopropyl)-2-vinylpyridinium
EC Number:
229-565-3
EC Name:
1-(3-sulphonatopropyl)-2-vinylpyridinium
Cas Number:
6613-64-5
Molecular formula:
C10H13NO3S
IUPAC Name:
3-(2-vinylpyridinium-1-yl)propane-1-sulfonate
Test material form:
solid: particulate/powder
Remarks:
light beige
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: sponsor

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a closed vessel dark and dry at ± 20°C.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0, 100 mg/l

Test solutions

Vehicle:
yes
Remarks:
algal medium (demineralised water enriched with minerals but without algae)
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution containing 100 mg/L test item in algal medium (demineralised water enriched with minerals but without algae) was prepared.
- Controls: yes, concurrent algal medium (negative control)
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none stated

Test organisms

Test organisms (species):
Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
Details on test organisms:
TEST ORGANISM
- Common name: Unicellular freshwater green alga
- Strain: Desmodesmus subspicatus, SAG Strain Number 86.81
- Source (laboratory, culture collection): The culture of Desmodesmus subspicatus was obtained in January 2016 by MBM Sciencebridge GmbH (Institut für Pflanzenphysiologie of Universität Göttingen). The algae are kept as stock culture on solid agar at 2 - 8 °C. From the stock culture, a permanent culture was prepared. From an aliquot of the permanent culture, the pre-culture was prepared.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
72 h
Post exposure observation period:
none

Test conditions

Test temperature:
19.8 – 22.6 °C
pH:
7.5 - 7.8
Nominal and measured concentrations:
Nominal: 0, 100 mg/l
Measured, at 0h: 0, 98 mg/l
Measured, at 72h: 0, 96 mg/ml
The concentrations to be tested are based on the result of a non-GLP pre-test, in which no inhibition of growth could be observed up to 100 mg/L.
Details on test conditions:
TEST SYSTEM
- Type (delete if not applicable): open, covered with perforated plastic foil acting as a stopper
- Material, size, headspace, fill volume: glass flasks, total volume 65 mL, filled with 45 ± 1 mL of the respective test solution
- Initial cells density: 2.3 *10E3 cells/mL
- Control end cells density: 135360 cells/ml
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6

GROWTH MEDIUM
- Standard medium used: yes

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous light
- Light intensity and quality: 5000 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : cell numbers, light intensity every 24h, pH and appearance at 0 and 72 h
- Determination of cell concentrations: electronic particle counter

TEST CONCENTRATIONS
- Spacing factor for test concentrations: n/a, limit test
- Range finding study
The concentration to be tested is based on non-GLP pre-tests, in which no inhibition of growth could be observed up to 100 mg/L.
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks:
and yield
Remarks on result:
not determinable
Remarks:
No significant inhibition of algal growth was observed.
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks:
and yield
Remarks on result:
other: No significant inhibition of algal growth was observed.
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks:
and yield
Remarks on result:
not determinable
Remarks:
No significant inhibition of algal growth was observed.
Details on results:
- Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): Normal and Healthy Appearance of the Algae
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50:
72h ErC50 = 0.94 mg/L (0.90 - 0.98 mg/L)
72h EyC50 = 0.42 mg/L (0.39 - 0.45 mg/L)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The study was conducted under GLP according to OECD guideline 201 and EU method C.3 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation or deviations from the guidelines, the validity criteria were met. Hence, the results can be considered as reliable to assess the toxicity of SPV towards algae.
The study was performed as a limit test at the concentration 100 mg/L. No significant inhibition of algal growth was observed.
The measured concentrations were 96 % and 98 % of the nominal concentration. Therefore, the determination of the results was based on the nominal concentration.
As no significant inhibition was observed at the limit dose of 100 mg/l, the EC50 for both growth rate and yield were >100 mg/l, and based on the results of this study, SPV does not need to be classified as hazardous to the environment, neither acute nor chronic.
Executive summary:

The study was conducted under GLP according to OECD guideline 201 and EU method C.3 on the registered substance itself.

One valid experiment was performed.

The study was performed as a limit test at the concentration 100 mg/L. Incubation time (test system Desmodesmus subspicatus) was 72 hours. The cell concentration of each replicate was determined by measuring the cell numbers every 24 hours with an electronic particle counter. Growth rate µ and the yield were determined from the cell number at the respective observation times.

No significant inhibition of algal growth was observed.

At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC.

The measured concentrations were 96 % and 98 % of the nominal concentration. Therefore, the determination of the results was based on the nominal concentration.

The 72h-EC50 values of potassium dichromate (K2Cr2O7, CAS No. 7778-50-9) were determined in a separate reference test. The values lay within the range of the laboratory (growth rate 0.73 - 1.10 mg/L, yield 0.21 – 0.66 mg/L).

The following results for the test item 1-(3-Sulfopropyl)-2-vinyl-pyridinumbetain (SPV) were determined:

Endpoint

NOEC

LOEC

EC50

Growth Rate

≥ 100 mg/L

> 100 mg/L

> 100 mg/L

Yield

≥ 100 mg/L

> 100 mg/L

> 100 mg/L

There is no statistically significant difference between control and 100 mg/L.

SPV does not need to be classified as hazardous to the environment, neither acute nor chronic.