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EC number: 468-740-0 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 18 Jul 2011 - 18 Aug 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP with analytical determination of concentrations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- MTDID 3285
- IUPAC Name:
- MTDID 3285
- Details on test material:
- - Name of test material (as cited in study report): MTDID 3285, CAS# 126049-00-1
- Substance type: Technical grade substance
- Physical state: Pink waxy solid with lumps
- Analytical purity: 86.67%
- Lot/batch no.: DZ-2200 - lot 30069
- Expiration date of the lot/batch: 31 May 2014
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: WSFs prepared at loading rates of 1.0, 10 and 100 mg/L for the rangefinding test, and 1.0, 3.2 and 10 mg/L for the definitive test.
- Sampling method: Aliquots (2 mL) were taken from dedicated test bottles at times 0, 24 hours and 72 hours. Parallel samples were taken of an uninoculated test bottle having growth medium prepared at the 10 mg/L loading rate to verify test substance stability in the medium.
At the end of the test, replicates were pooled at each concentration before sampling.
- Sample storage conditions before analysis: Samples were stored frozen (≤-15 °C) until the day before analysis, thawed, diluted with an equal volume of methanol, and held overnight at room temperature before analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water soluble fraction. Loading rates of 1.0, 3.2 and 10 mg/L were sonicated for ten minutes and then were stirred for three days. Undissolved material present in the test solutions was removed by filtration through 0.45 µm membranes. Portions of the solution loaded at 1.0 mg/L was then further diluted to produce 10% and 32% dilution. The final test solutions were all clear and colourless.
- Controls: Blank
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None after the filtration step
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: NIVA CHL 1
- Source (laboratory, culture collection): In-house laboratory culture
- Age of inoculum (at test initiation): 3 days prior to test initiation, cells from algal stock culture were inoculated in culture medium at a cell density of 10,000 cells/mL. Cells counts were obtained using a microscope and counting chamber.
- Method of cultivation: In M1 growth medium, continuously aerated and exposed to 60- 120 µE/(m²∙s) in the wavelength range of 400 to 700 nm at 21 - 24 °C.
ACCLIMATION
- Acclimation period: 3 days in M2 pre-culture medium
- Culturing media and conditions (same as test or not): Same during acclimation period
- Any deformed or abnormal cells observed: None noted
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg CaCO3 / L
- Test temperature:
- 22.0 °C - 23.4 °C
- pH:
- 8.0 - 8.3
- Dissolved oxygen:
- NA
- Salinity:
- NA
- Nominal and measured concentrations:
- Nominal concentrations: Based on WSF loading rates: Control (blank), 0.10* mg/L, 0.32* mg/L, 1.0 mg/L, 3.2 mg/L, 10 mg/L.
* denotes solutions made as 10% and 32% dilutions of the 1.0 mg/L loading rate
Mean measured concentrations: <0.002 mg/L (blank), 0.08 mg/L, 0.23 mg/L, 0.78 mg/L, 2.60 mg/L, 8.60 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100-mL glass vessels filled to 50 mL.
- Aeration: Continuous shaking.
- No. of organisms per vessel: initial cell density was 1E+04 cells/mL (fresh dilution of 3 day old culture).
- No. of vessels per concentration (replicates): three
- No. of vessels per control (replicates): six
- Extra replicates for sampling: yes, inoculated bottles of each concentration for sampling, plus one uninoculated bottle at 10 mg/L for sampling..
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water used to make growth medium was tap water purified by reverse osmosis.
- Culture medium different from test medium: yes, propagation in M1, test in M2 (OECD TG201 medium).
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: continuous illumination using 30 Watt 'Cool-white' TLD-Iamps. Light intensity within the range of 78 to 91 µE/(m²∙s)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-Cell counts by microscopy with counting chamber at start of test. Cell counts at 24, 48 and 72 hours determined by spectrophotometric measurement at 720 nm using a Shimadzu UV-1800 spectrophotometer with immersion probe. Microscopic observation of cells in highest test concentration showing < 20% effect, at end of test only.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2 (0.5 log unit)
- Range finding study: Yes
- Test concentrations: WSFs based on 1.0 mg/L, 10 mg/L and 100 mg/L loading rates, plus 10% dilution of 1.0 mg/L WSF
- Results used to determine the conditions for the definitive study: Yes. EC50 between 1.0 and 10 mg/L loading rate. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate, reference test done 7 weeks prior to the definitive MTDID 3285 test
Results and discussion
Effect concentrations
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.3 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- act. ingr.
- Remarks:
- anionic component
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 1.2-1.4 mg/L; NOEC: 0.23 mg/L; EC10: 0.75 mg/L (95% CI: 0.69-0.81 mg/L)
- Details on results:
- Measured concentrations in the definitive test are shown in Table 1. Concentrations of both the anionic and cationic portions of the substance were measured. Because Time-weighted average concentrations were somewhat lower for the anion, EC50 is calculated using based on anion measurements. The average concentration during the test was calculated using:
Concentration = 24/72*sqrt(C0 x C24) + 48/72*sqrt(C24 x C72)
where C0, C24, C48 and C72 are the concentrations at 0, 24, 48 and 72 and hours.
In the definitive test, the control group had >16-fold growth by 72 hours. The mean CV for section-by-section specific growth rate was 15% over this period, with variation in average specific growth rates of 1% (Tables 2, 3).
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No. Test solutions were clear and colorless after filtration. There was no indication that the standards contained any insoluble material
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- In a test of potassium dichromate conducted 7 weeks prior to the definitive test, a 72-h EC50 of 1.9 mg/L was observed. This EC50 is within the range of values for reference tests of P. subcapitata performed by the testing lab.
Any other information on results incl. tables
Table 1, Concentrations of MTDID 3285 in the test medium based on anion concentration |
|||
Time of sampling (hour) |
Concentration (mg/L) |
Percent of initial concentration |
|
Loading rate |
Analysed |
||
0 |
0 |
<0.002 |
─ |
10% dilution |
0.0928 |
─ |
|
32% dilution |
0.282 |
─ |
|
1.0 |
0.913 |
─ |
|
3.2 |
2.48 |
─ |
|
10 |
9.46 |
─ |
|
10¹ |
9.70 |
─ |
|
|
|||
24 |
0 |
<0.002 |
─ |
10% dilution |
0.0899 |
97 |
|
32% dilution |
0.269 |
96 |
|
1.0 |
0.880 |
96 |
|
3.2 |
2.68 |
108 |
|
10 |
9.71 |
103 |
|
10¹ |
9.51 |
98 |
|
72 |
0 |
<0.002 |
─ |
10% dilution |
0.0621 |
67 |
|
32% dilution |
0.163 |
58 |
|
1.0 |
0.597 |
65 |
|
3.2 |
2.59 |
105 |
|
10 |
7.19 |
76 |
|
10¹ |
7.99 |
82 |
|
1, Test bottle prepared without algae |
Table 2, Individual cell densities in test bottles during the algae tests |
|||||
Concentration (mg/L)¹ |
Vessel number |
Cell density (x 1E+04) at exposure time: |
|||
0 hours |
24 hours |
48 hours |
72 hours |
||
Control |
1 |
1.00 |
6.93 |
40.94 |
172.73 |
2 |
1.00 |
7.44 |
40.53 |
173.81 |
|
3 |
1.00 |
7.68 |
42.92 |
165.18 |
|
4 |
1.00 |
7.34 |
40.37 |
170.64 |
|
5 |
1.00 |
7.67 |
40.79 |
168.97 |
|
6 |
1.00 |
7.80 |
39.87 |
162.19 |
|
|
|||||
1 |
1.00 |
8.08 |
42.20 |
171.55 |
|
0.08 |
2 |
1.00 |
7.30 |
37.55 |
161.34 |
3 |
1.00 |
6.73 |
38.34 |
168.91 |
|
|
|||||
1 |
1.00 |
6.94 |
31.84 |
140.21 |
|
0.23 |
2 |
1.00 |
7.48 |
37.76 |
150.45 |
3 |
1.00 |
8.21 |
44.80 |
185.52 |
|
|
|||||
1 |
1.00 |
7.37 |
27.53 |
96.20 |
|
0.78 |
2 |
1.00 |
6.41 |
23.91 |
80.34 |
3 |
1.00 |
6.35 |
23.85 |
87.14 |
|
|
|||||
1 |
1.00 |
2.01 |
2.59 |
1.00 |
|
2.60 |
2 |
1.00 |
2.37 |
3.19 |
1.17 |
3 |
1.00 |
1.00 |
2.30 |
1.00 |
|
|
|||||
1 |
1.00 |
1.07 |
1.84 |
1.00 |
|
8.80 |
2 |
1.00 |
1.54 |
2.50 |
1.00 |
3 |
1.00 |
1.00 |
1.77 |
1.00 |
|
1, Time weighted average concentration based on anion concentration |
Table 3, Specific growth rates and Percent growth inhibition during the algae tests |
|||||||||
Time-weighted average conc. (mg/L) |
Vessel number |
Growth rate (/hour) during section: |
Percent growth inhibition by section (h): |
||||||
0-24 h |
24-48 h |
48-72 h |
0-72 h |
0-24 |
24-48 |
48-72 |
0-72 |
||
Control (<0.002) |
1 |
0.08066 |
0.07401 |
0.05998 |
0.07155 |
─ |
─ |
─ |
─ |
2 |
0.08361 |
0.07064 |
0.06066 |
0.07164 |
─ |
─ |
─ |
─ |
|
3 |
0.08496 |
0.07168 |
0.05615 |
0.07093 |
─ |
─ |
─ |
─ |
|
4 |
0.08306 |
0.07103 |
0.06006 |
0.07138 |
─ |
─ |
─ |
─ |
|
5 |
0.08490 |
0.06961 |
0.05922 |
0.07125 |
─ |
─ |
─ |
─ |
|
6 |
0.08556 |
0.06800 |
0.05847 |
0.07068 |
─ |
─ |
─ |
─ |
|
mean |
0.08379 |
0.07083 |
0.05909 |
0.07124 |
─ |
─ |
─ |
─ |
|
CV |
2% |
3% |
3% |
1% |
|
||||
Mean CV for section-by-section specific growth rate: 15% |
|||||||||
1 |
0.08707 |
0.06887 |
0.05843 |
0.07146 |
-4 |
3 |
1 |
0 |
|
0.08 |
2 |
0.08280 |
0.06827 |
0.06075 |
0.07060 |
1 |
4 |
-3 |
1 |
3 |
0.07943 |
0.07251 |
0.06179 |
0.07124 |
5 |
-2 |
-5 |
0 |
|
|
|
||||||||
1 |
0.08069 |
0.06350 |
0.06177 |
0.06865 |
4 |
10 |
-5 |
4 |
|
0.23 |
2 |
0.08383 |
0.06746 |
0.05760 |
0.06963 |
0 |
5 |
3 |
2 |
3 |
0.08772 |
0.07070 |
0.05921 |
0.07254 |
-5 |
0 |
0 |
-2 |
|
|
|
||||||||
1 |
0.08320 |
0.05493 |
0.05213 |
0.06342 |
1 |
22 |
12 |
11 |
|
0.78 |
2 |
0.07740 |
0.05485 |
0.05051 |
0.06092 |
8 |
23 |
15 |
14 |
3 |
0.07700 |
0.05516 |
0.05399 |
0.06205 |
8 |
22 |
9 |
13 |
|
|
|
||||||||
1 |
0.02909 |
0.01055 |
0.00000 |
0.00000 |
65 |
85 |
100 |
100 |
|
2.60 |
2 |
0.03602 |
0.01228 |
0.00000 |
0.00217 |
57 |
83 |
100 |
97 |
3 |
0.00000 |
0.03465 |
0.00000 |
0.00000 |
100 |
51 |
100 |
100 |
|
|
|
||||||||
1 |
0.00262 |
0.02269 |
0.00000 |
0.00000 |
97 |
68 |
100 |
100 |
|
8.8 |
2 |
0.01810 |
0.02015 |
0.00000 |
0.00000 |
78 |
72 |
100 |
100 |
3 |
0.00000 |
0.02379 |
0.00000 |
0.00000 |
100 |
66 |
100 |
100 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- 16-fold growth in controls, <1% Coefficient of Variation (COV) for average specific growth rate, 15% COV for section specific growth rates
- Conclusions:
- The 72-hour EC50 for MTDID 3285 to the green algae Pseudokirchneriella subcapitata is 1.3 mg/L
- Executive summary:
The toxicity of MTDID 3285 to the green algae Pseudokirchneriella subcapitata was assessed in a 72-hour test. Water-soluble fractions (WSFs) were made using loading rates of 1.0, 3.2, and 10 mg/L, and the 1.0 mg/L loading rate was additionally diluted to 10% and 32% to cover a lower concentration range. Analytically measured concentrations were similar to loading rates. Time weighted average concentrations for both the cationic and anion portions of the substance were determined using analytical results, with the anion concentrations providing the more conservative result. The 72-hour EC50 of MTDID 3285 to Pseudokirchneriella subcapitata was 1.3 mg/L based on growth rate. The 72-hour NOEC was 0.23 mg/L. The 72-hour EC10 was 0.75 mg/L.
The study was conducted under accepted guidelines and according to GLP criteria. The test material contained an unspecified amount of insoluble material which was removed by filtration. Also, anion concentrations declined during the test period whereas the cation remained stable. However, analytically determined concentrations on a time-weighted basis were similar to nominal concentrations. There was no indication that the standards, which were made in 50% (v/v) methanol, contained any undissolved material. Therefore, the study is classified as reliable and is suitable for use in classification and labelling.
Results Synopsis
Test Type: Static
EC50: 1.3 mg/L 95% C.I.: 1.2-1.4 mg/L
NOEC: 0.23 mg/L Probit Slope: NA
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