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EC number: 915-610-0 | 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
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 - 07 Sep 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Staatliches Gewerbeaufsichtsamt Hildesheim, Germany (03.01.2017)
- Analytical monitoring:
- yes
- Remarks:
- GC-MS
- Details on sampling:
- - Concentrations: All concentration levels including the control at 0 h (test start), 24 h, 48 h, and 72 h (test end).
- Sampling method: For test item analysis at the beginning of the exposure, separate replicates for each test item concentration and control were prepared with algae. The samples for the test item analysis after 24, 48, and 72 h were prepared with algae and incubated under test conditions.
- Sample storage conditions before analysis: All samples were stored at 6 ± 2 °C until sample preparation and at room temperature until the start of the analysis (on an autosampler), if necessary. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Five dilution levels were prepared by dilution of the stock solution with a nominal concentration of 100 mg/L test item (dilution factor 10^(1/2)). The stock solution was prepared 1 d prior to the start of exposure by stirring the dispersion for 24 h at 1100 rpm at room temperature.
- Controls: Dilution water without test item incubated under the same conditions as the test concentrations.
- Evidence of undissolved material: The test media were clear throughout the exposure phase. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular green alga
- Age of inoculum (at test initiation): A 3 d old preculture prepared in dilution water was used as inoculum for the test.
- Method of cultivation: Fresh stocks are prepared every month on Z-Agar at 2590 - 5180 lux for 24 h/d.
- Culture medium: Nutrient medium Z, according to Lüttge et al. 1994 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- 0.24 mmol Ca+Mg/L (dilution water)
- Test temperature:
- 22.5 °C (mean room temperature)
- pH:
- 0 h: 8.24 (control), 7.93 - 8.01 (treatments)
72 h: 9.36 (control), 8.08 - 9.29 (treatments) - Nominal and measured concentrations:
- Control, 0.800, 2.53, 8.00, 24.3, and 80.0 mg/L (nominal)
Control, 0.813, 2.35, 6.53, 22.2, and 64.4 mg/L (time-weighted average) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Sterile 59 mL flasks without headspace (59 mL test volume), sealed with aluminium tops and PTFE
- Initial cell density: 6839 cells/mL
- Control end cell density: 612085 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: Nutrient medium Z, according to Lüttge et al. 1994
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD medium 201
- Culture medium different from test medium: Culture medium: Nutrient medium Z; Test medium: OECD medium 201 (dilution water)
- Intervals of water quality measurement: The pH values at the start of exposure were measured in one additional replicate of each test item concentration and the control. At the end of exposure, the pH values were measured from pooled samples of each test item concentration and the control.
OTHER TEST CONDITIONS
- Sterile test conditions: Yes
- Photoperiod: 24 h light/d
- Light intensity and quality: 4440 - 8880 lux, 60 - 120 µE*m^-2*s^-1
- Other: The test vessels were randomly placed on a rotary shaker oscillating at approximately 70 rpm and were repositioned daily.
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Chlorophyll a-fluorescence
- Chlorophyll measurement: At 0, 24, 48, and 72 h using a Fluorometer (Microplate Reader Chameleon V, Hidex). Excitation: 436 nm; Emission 685 nm
- Microscopic evaluation: At test start (0 h) and end (72 h)
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.16
- Range finding study: Yes, one non-GLP preliminary range-finding test was conducted.
- Test concentrations: Control, 1.00, 10.0, and 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: Yes, after 72 h 100% growth rate inhibition was recorded at 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.72 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 7.45 - 13.0
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 6.1 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 4.96 - 6.41 mg/L
- Details on results:
- - Exponential growth in the control: Yes, cell growth in the control cultues increased 89-fold (specific growth rate 1.50/d)
- Observation of abnormalities: No morphological abnormalities
- Any stimulation of growth found in any treatment: Growth stimulation was observed at 0.813 and 2.35 mg/L (time weighted average test item concentration)
- Any observations that might cause a difference between measured and nominal values: The test media were clear throughout the exposure.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? The results of the reference item test were in the valid range of 0.773 ± 0.540 mg/L.
- ErC50 (72 h): 0.559 mg/L (with headspace), 0.811 mg/L (without headspace).
- Other: The reference test was conducted with potassium dichromate from 18 - 21 Apr 2017 (with headspace) and 10 - 13 Oct 2016 (without headspace). - Reported statistics and error estimates:
- The EC values were calculated by sigmoidal dose-response regression. The NOEC/LOEC was determined by calculation of statistical significance of growth rate and yield using the following tests:
- Shapiro-Wilk's test on normal distribution (significance level = 0.01)
- Levene's Test on variance homogeneity (significance level = 0.01)
- Trend analysis by contrasts on monotonicity of Concentration/Response (significance level = 0.05)
- Williams Multiple t-test (significance level = 0.05)
ECx CALCULATION FOR GROWTH RATE USING TIME WEIGHTED AVERAGE TEST ITEM CONCENTRATION
- Equation: Sigmoidal dose-response (variable slope). Y = Bottom + (Top - Bottom)/(1+10^((log EC50-X)*HillSlope))
- Transform: x = log(x)
- Fitting results: Bottom = -1.005, Top = 100.2, log EC50 = 0.9392, HillSlope = 5.941, EC50 = 8.717, EC10 = 6.101
- Goodness of fit: Degrees of freedom: 11; R square: 0.9985; Absolute Sum of Squares: 49.66, Sy.x: 2.125 - Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to "Any other information on results incl. tables".
- Conclusions:
- The guideline study resulted in an ErC50 (72 h) of 8.72 mg/L and an ErC10 (72 h) of 6.10 mg/L for aquatic algae (OECD 201, P. subspicatus).
- Executive summary:
The short-term toxicity of the test item to aquatic invertebrates was assessed according to OECD guideline 202 and GLP. In a static test using closed test vessels without headspace, Daphnia magna was exposed to five nominal test item concentrations ranging from 1.25 to 20.0 mg/L in a geometric series with a dilution factor of 2. Test item concentrations in all treatment levels were analytically verified in fresh media at the beginning of the test (0 h) and in aged media at the end of the test (48 h) by GC-MS. The measured test item concentrations in fresh media at 0 h ranged from 1.08 to 17.1 mg/L. The measured test item concentrations in aged media at 48 h ranged from 91 – 100% of the measured initial concentrations in the fresh media, indicating that test item concentrations were stable throughout the duration of the test. Therefore, all effect concentrations were based on the measured initial concentrations of the test item. After 48 h immobilization was observed and an EC50 (48 h) of 8.30 mg/L was obtained.
Reference
VALIDITY CRITERIA
The study met the validity criteria laid down by the guideline (Table 1).
Table 1: Validity criteria for OECD 201.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period. |
Increase of cell growth in control: 89-fold, specific growth rate: 1.50/d |
Yes |
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35% |
The mean coefficient of variation for section-by-section specific growth rates in the control: 25.5% |
Yes |
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata and Desmodesmus subspicatus. |
Coefficient of variation of average specific growth rates in control culture replicate s: 1.45% |
Yes |
ANALYTICAL RESULTS
The measured test item concentrations were 77 – 111% of the nominal values at the start of exposure at 0 h, 79 – 108% after 24 h, 79 – 100% after 48 h and 74 – 90% after 72 h (Table 2). All effect values are expressed as time weighted average test item concentrations.
Table 2. Measured concentrations and percentage of the nominal concentrations of test item.
nominal test item concentration [mg/L] |
0 h |
24 h |
48 h |
72 h |
||||
meas. conc. [mg/L] |
[%] |
meas. conc. [mg/L] |
[%] |
meas. conc. [mg/L] |
[%] |
meas. conc. [mg/L] |
[%] |
|
80.0 |
70.7 |
88 |
63.5 |
79 |
63.2 |
79 |
62.7 |
78 |
25.3 |
19.8 |
78 |
20.8 |
82 |
25.4 |
100 |
21.8 |
86 |
8.00 |
6.17 |
77 |
6.54 |
82 |
7.05 |
88 |
5.90 |
74 |
2.53 |
2.42 |
95 |
2.39 |
95 |
2.43 |
96 |
2.04 |
80 |
0.800 |
0.889 |
111 |
0.864 |
108 |
0.779 |
97 |
0.717 |
90 |
control |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
Meas. conc. = measured concentration of the test item
% = percentage of the nominal concentration of the test item
LOQ = Limit of quantification (0.05 mg test item/L)
BIOLOGICAL RESULTS
After 72 h growth inhibition by the test item was observed (Table 3). The NOEC (72 h) and LOECD (72 h) for inhibition of growth rate and yield was 2.35 mg/L and 6.53 mg/L, respectively.
Table 3. Evaluation after 72 hours.
Time weighted average test item concentration
|
Replicate no. |
Growth rate |
Inhibition of growth rate |
Yield |
Inhibition of yield |
[mg/L] |
|
[d^-1] |
[%] |
[cells/mL] |
[%] |
64.4 |
1 |
n.a. |
100 |
n.a. |
100 |
2 |
n.a. |
100 |
n.a. |
100 |
|
3 |
n.a. |
100 |
n.a. |
100 |
|
Mean |
(+) n.a. |
100 |
(+) n.a. |
100 |
|
22.2 |
1 |
n.a. |
100 |
n.a. |
100 |
2 |
n.a. |
100 |
n.a. |
100 |
|
3 |
n.a. |
100 |
n.a. |
100 |
|
Mean |
(+) n.a. |
100 |
(+) n.a. |
100 |
|
6.53 |
1 |
1.24 |
17 |
275120 |
55 |
2 |
1.31 |
12 |
342008 |
43 |
|
3 |
1.29 |
14 |
316494 |
48 |
|
Mean |
(+) 1.28 |
15 |
(+) 311207 |
49 |
|
2.35 |
1 |
1.44 |
4 |
512360 |
15 |
2 |
1.49 |
0 |
595283 |
2 |
|
3 |
1.51 |
-1 |
621032 |
-3 |
|
Mean |
(-) 1.48 |
1 |
(-) 576225 |
5 |
|
0.813 |
1 |
1.54 |
-3 |
678879 |
-12 |
2 |
1.53 |
-2 |
671066 |
-11 |
|
3 |
1.56 |
-4 |
734912 |
-21 |
|
Mean |
(-) 1.54 |
-3 |
(-) 694952 |
-15 |
|
Control |
1 |
1.54 |
|
681600 |
|
2 |
1.50 |
|
613073 |
|
|
3 |
1.48 |
|
572841 |
|
|
4 |
1.49 |
|
587236 |
|
|
5 |
1.50 |
|
606841 |
|
|
6 |
1.48 |
|
569885 |
|
|
Mean |
1.50 |
|
605246 |
|
Negative values = growth stimulation
N.a. = not applicable
Description of key information
ErC10 = 6.10 mg/L (measured, time weighted average, OECD 201, S. subspicatus)
ErC50 = 8.72 mg/L (measured, time weighted average, OECD 201, S. subspicatus)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 8.72 mg/L
- EC10 or NOEC for freshwater algae:
- 6.1 mg/L
Additional information
There is one study available, in which the toxicity of the test item to aquatic algae was assessed according to OECD 201 and GLP.
In a static test, P. subcapitata at an initial cell density of 6839 cells/mL was exposed to five concentration levels in a geometric series with a separation factor of 10^(1/2) ranging from 0.80 – 80.0 mg/L (nominal) in closed test vessels without headspace for 72 h. Test item concentrations in all treatment levels and the control were analytically verified by GC-MS at the start of exposure (0 h) and after 24, 48 and 72 h.
The measured concentrations at the start of exposure (0 h) ranged from 77 to 111% of the nominal values and were 79 – 108% of nominal after 24 h, 79 – 100% after 48 h and 74 – 90% after 72 h, indicating that the test item was stable for the duration of the test. All effect values were expressed as time weighted average of measured test item concentrations.
After 72 h, the test item was found to inhibit cell growth and an ErC10 (72 h) of 6.10 mg/L as well as an ErC50 (72 h) of 8.72 mg/L was obtained.
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