Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-684-5 | 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:
- 2015-09-20 to 2015-09-24
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- Water accommodated fraction
In view of the difficulties associated with the evaluation of aquatic toxicity of poorly water soluble test items, a modification of the standard method for the preparation of aqueous media was performed. An approach endorsed by several important regulatory authorities in the EU and elsewhere (ECETOC 1996 and OECD 2000), is to expose the organisms to a Water Accommodated Fraction (WAF) of the test item in cases where the test item is a complex mixture and is poorly soluble in water and in the permitted solvents. Using this approach, aqueous media were prepared by mixing the test item with water for a prolonged period sufficient to ensure equilibration between the test item and the water phase.
Preparation of test solutions
For the single water accommodated fraction (WAF) 100 mg/L of the test item were weighed out and transferred into a brown glass flask with dilution water one day prior to application. The WAF was shaken with 20 rpm for 24 hours at room temperature. After a separation phase of at least 1 hour the WAF was taken from the homogeneous liquid phase from the bottom of the water body.
Test loading
Per definition of the WAF all terms related to concentration level are given as loading level because partly dissolved compounds and mixtures cannot be related to concentrations. The water accomodated fraction (WAF) will be tested in a limit test.
Test concentrations
One limit concentration of 100 mg/L was tested. The limit concentration is based on the results of a preliminary range finding test (non GLP).
Control
Six replicates (without test item) were tested under the same test conditions as the test replicates. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: Pseudokirchneriella subcapitata HINDÁK, SAG 61.81
- Source (laboratory, culture collection): Sammlung von Algenkulturen (SAG)
Pflanzenphysiologisches Institut der Universität Göttingen
Nikolausberger Weg 18, D-37073 Göttingen
- Age of inoculum (at test initiation): A three day old preculture, prepared in dilution water, was used as inoculum.
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 35 - 70 µE • m-2 • s-1 for 24 hours per day.
ACCLIMATION
- Acclimation period: three days
- Culturing media and conditions (same as test or not): same as test
- Any deformed or abnormal cells observed: no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- min: 22:0
max: 23.0
mean: 22.5 - pH:
- Nominal test item concentration pH-value
[mg/L] Start; 0 hours End; 72 hours
100 8.01 9.07
Control 8.10 8.95 - Nominal and measured concentrations:
- nominal: 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Sterile Erlenmeyer flasks
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 250 mL, with headspace,100 mL
- Initial cells density: 6153 cells/ml
- Control end cells density: 2666336 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
- No. of vessels per vehicle control (replicates): 0
GROWTH MEDIUM
- Standard medium used: yes
- Detailed composition if non-standard medium was used:
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 hours/day cool daylight
- Light intensity and quality: 60 - 120 µE • m-2 • s-1 , within ± 15 % over incubation area
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Type and frequency of measurement
Cell density was measured daily via Chlorophyll-a-fluorescence, excitation at 436 nm, emission at 685 nm. Dilution water was used as background signal. No Self-fluorescence was found in the range finding test.
Microscope evaluation
Microscopic evaluation of the cells at the start and end of the exposure was carried out. The cells were checked for unusual cell shapes, colour differences, differences in chloroplast morphology, flocculation, adherence of algae to test containers and agglutination of algae cells. - Reference substance (positive control):
- yes
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- Microscopic evaluation of the cells at the start and the end of the exposure period revealed no morphological abnormalities. All effect values are given based on the WAF prepared with a nominal loading concentration of 100 mg/L.
- Results with reference substance (positive control):
- The toxicity of potassium dichromate (SIGMA, batch number MKBQ9179V, purity 100.0 %, CAS RN 7778-50-9) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined over a period of 72 hours from 2015-04-14 to 2015-04-17 (with headspace). The reference item toxicity is in the valid range following test facility SOPs.
EC50-Values of the Reference Item
based on nominal concentrations mg/L, (0-72 hours)
Current Study Valid Range (average ± 3 x SD)
Growth Rate inhibition
ErC50 0.613 0.810 ± 0.404
95 % confidence interval 0.589 - 0.638
Yield inhibition
EyC50 0.281 0.421 ± 0.274
95 % confidence interval 0.234 - 0.314
SD = Standard deviation - Reported statistics and error estimates:
- EC-values and statistical analyses
EC-values of the growth rate and yield inhibition were estimated empirically based on the results of the only treatment level (Limit test design).
NOEC and LOEC values
NOEC/LOEC were determined by calculation of statistical significance of growth rate and yield. As standard a t-test was used for NOEC/LOEC calculations. When running a t-test a Normality test and an Equal Variance test were done first. The SHAPIRO-WILK-Test was used to test for normally distributed populations. The Levene median test was used for equal variance. P-values for both Normality and Equal Variance tests are 0.05. The -value (acceptable probability of incorrectly concluding that there is a difference) is =0.05.
Software
The data for the tables in this report were computer generated and have been rounded for presentation from the full derived data. Consequently, if calculated manually based on the given data minor deviations may occur from these figures.
Calculations were carried out using software
• Excel, MICROSOFT CORPORATION
• SigmaPlot, SPSS INC. - Validity criteria fulfilled:
- yes
- Conclusions:
- In this study the test item was found not to inhibit the growth rate of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours. The NOEC-value of the test item for both inhibition of growth rate and inhibition of yield after 72 hours was 100 mg/L. The EC50-values of the test item for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were both > 100 mg/L, respectively.
All effect levels are given based on the water accommodated fraction prepared with a nominal concentration of 100 mg/L of Lthe test item. - Executive summary:
The toxicity of the test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 (2011 )and Council Regulation (EC) No.761/2009/Method C.3 (2008) at Dr.U.Noack-Laboratorien in 31157 Sarstedt, Germany from 2015-09-20 to 2015-09-24 with the definitive exposure phase from 2015-09-21 to 2015-09-24. The aim of the study was to assess the effects on growth rate and yield over a period of 72 hours.
The study was conducted under static conditions with an initial cell density of 6153 cells/mL. A water accommodated fraction with a nominal concentration of 100 mg/L was tested. Six replicates were tested for the limit concentration and the control. Environmental conditions were determined to be within the acceptable limits.
No analytical determination was carried out since no suitable method for the determination of the test item could be established. All effect values of LICOWAX R21 S FL are given based on the nominal concentration.
NOEC, LOEC, EC - values of the test item (0-72 hours)
based on the water accommodated fraction, prepared with 100 mg/L
Growth Rate Inhibition
Nominal test item concentration [mg/L]NOEC
100
LOEC
> 100
ErC10
> 100
ErC20
> 100
ErC50
> 100
Inhibition of Yield
Nominal test item concentration [mg/L]
NOEC
100
LOEC
> 100
EyC10
> 100
EyC20
> 100
EyC50
> 100
Reference
Cell Densities
Nominal test item concentration |
Replicate |
Cell density [cells/mL] |
|||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
100 |
1 |
6153 |
42932 |
445275 |
2339481 |
2 |
6153 |
37714 |
437497 |
2376862 |
|
3 |
6153 |
44911 |
489963 |
2621345 |
|
4 |
6153 |
45867 |
449351 |
2356917 |
|
5 |
6153 |
41333 |
424389 |
2649820 |
|
6 |
6153 |
42164 |
444773 |
2517794 |
|
Mean |
6153 |
42487 |
448541 |
2477037 |
|
Control |
1 |
6153 |
45090 |
500594 |
2925913 |
2 |
6153 |
41963 |
431758 |
2489758 |
|
3 |
6153 |
39401 |
438626 |
2596571 |
|
4 |
6153 |
44324 |
480617 |
2575622 |
|
5 |
6153 |
41097 |
455937 |
2647687 |
|
6 |
6153 |
47586 |
489900 |
2762465 |
|
Mean |
6153 |
43244 |
466239 |
2666336 |
Evaluation after 72 hours
Statistically significant differences of growth rates and yield compared to control values are marked (+), not significant differences are marked (-).
Nominal test item concentration |
Replicate |
Growth rate |
Inhibition of growth rate |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
100 |
1 |
|
1.98 |
2 |
|
2333328 |
12 |
2 |
|
1.99 |
2 |
|
2370709 |
11 |
|
3 |
|
2.02 |
0 |
|
2615192 |
2 |
|
4 |
|
1.98 |
2 |
|
2350764 |
12 |
|
5 |
|
2.02 |
0 |
|
2643667 |
1 |
|
6 |
|
2.01 |
1 |
|
2511641 |
6 |
|
Mean |
(+)* |
2.00 |
1 |
(-) |
2470884 |
7 |
|
Control |
1 |
|
2.06 |
|
|
2919760 |
|
2 |
|
2.00 |
|
|
2483605 |
|
|
3 |
|
2.02 |
|
|
2590418 |
|
|
4 |
|
2.01 |
|
|
2569469 |
|
|
5 |
|
2.02 |
|
|
2641534 |
|
|
6 |
|
2.04 |
|
|
2756312 |
|
|
Mean |
|
2.02 |
|
|
2660183 |
|
* = biologically not significant
Section-by-Section and Average Specific Growth Ratesof the Control Group (0 – 72 hours)
|
Replicate No. |
Specific growth rate [d-1] |
Mean (0 - 72 h) |
SD ± |
CV |
Mean CV [%] |
||
section-by-section |
||||||||
0 - 24 hours |
24 - 48 hours |
48 - 72 hours |
||||||
Control |
1 |
1.99 |
2.41 |
1.77 |
2.06 |
0.325 |
15.8 |
16.2 |
2 |
1.92 |
2.33 |
1.75 |
2.00 |
0.298 |
14.9 |
||
3 |
1.86 |
2.41 |
1.78 |
2.02 |
0.344 |
17.1 |
||
4 |
1.98 |
2.38 |
1.68 |
2.01 |
0.354 |
17.6 |
||
5 |
1.90 |
2.41 |
1.76 |
2.02 |
0.341 |
16.8 |
||
6 |
2.05 |
2.33 |
1.73 |
2.04 |
0.301 |
14.8 |
||
|
|
|
Mean |
2.02 |
|
|
||
|
|
|
SD ± |
0.02 |
|
|||
|
|
|
CV [%] |
0.95 |
|
CV= Coefficient of variation
SD= Standard deviation
Description of key information
In this study the test item was found not to inhibit the growth rate of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours. The NOEC-value of the test item for both inhibition of growth rate and inhibition of yield after 72 hours was 100 mg/L. The EC50-values of the test item for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were both > 100 mg/L, respectively.
All effect levels are given based on the water accommodated fraction prepared with a nominal concentration of 100 mg/L of Lthe test item.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.