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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 271-668-0 | CAS number: 68603-62-3
- 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:
- 17 December 2017 to 11 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2006, corrected 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All test concentrations, including control
- Sampling method: Analytical samples were taken in the main test at 0 hours (initial value) from fresh test solutions and after 72 hours from aged test solutions from all test item concentrations and control. For each sampling timepoint, a retained sample was also taken.
- Sample storage conditions before analysis: All samples were stored deep frozen until they were transferred to the analytical laboratory. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water Accommodated Fraction (WAF) - The test item was applied as water accommodated fraction (WAF). Stock solutions (S1, S2) were prepared by directly weighing the necessary amount of test item in test medium. These stock solutions were stirred in the dark at room temperature for 48 h (based on OECD Series on Testing and Assessment No. 23). The solutions were clear and transparent. After the settling of one hour Tyndall’s effect could be observed for S1 and S2. The stock solutions were centrifugated for one hour at 5000 rpm. Afterwards only S1 showed a slight Tyndall`s effect. Lower test solutions were prepared by dilution of appropriate solutions with test medium.
- Eluate: AAP-Medium
- Differential loading: 10.0, 3.13, 0.977, 0.305, 0.0954 mg/L
- Controls: Test medium only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Not present in test solutions used for study (aqueous phase of WAF siphoned off) - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Not applicable
- Strain: SAG 61.81
- Source (laboratory, culture collection): laboratory culture
- Age of inoculum (at test initiation): 3 to 4 days before start of the test, test medium was inoculated with the test organism and held under test conditions in order to produce a pre-culture in the state of exponential growth.
- Method of cultivation: The algae are grown semi-continuously in sterile cultures in the laboratory. Old medium is periodically replaced by fresh mineral solution in order to keep the algae in an exponential growth state. Stock cultures are ordered regularly from our commercial supplier.
ACCLIMATION
- Acclimation period: Not applicable (laboratory culture)
- Culturing media and conditions (same as test or not): Yes
- Any deformed or abnormal cells observed: None reported - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- Stabdard guideline exposure duration
- Test temperature:
- 22.2 – 23.6 °C
- pH:
- 7.38 – 8.13
- Nominal and measured concentrations:
- Nominal Concentrations: 10.0, 3.13, 0.977, 0.305, 0.0954 mg/L and control
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Type (delete if not applicable): closed (aluminium caps)
- Material, size, headspace, fill volume: glass, 100 mL, 50 mL
- Aeration: CO2 supply by continuous agitation: Test vessels were placed in an incubator on a pivoted bogie which turns around and induces shaking by regular sudden stops.
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- Initial cells density: 0.5 E +04
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- No. of vessels per vehicle control (replicates): Not applicable
GROWTH MEDIUM
- Standard medium used: yes AAP-Medium (according to Annex 3 of OECD 201)
- Detailed composition if non-standard medium was used: Not applicable
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: No
- Intervals of water quality measurement: Measurements of pH-value were performed at t = 0 h and t = 72 h, the temperature was measured continuously and recorded at hours 0, 24, 48 and 72 h. The light intensity of all positions of the incubator is measured once a year and was confirmed for one representative position at test start.
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: No
- Photoperiod: 24 h light
- Light intensity and quality: Continuously, 88.8 µEm-2s-1 (mean)
- Salinity (for marine algae): Not applicable
EFFECT PARAMETERS MEASURED
Growth determination was performed by fluorescence measurement.
The fluorescence measurements were performed with a fluorescence microplate reader (infinite 200Pro) with an emission wavelength of 670 nm and evaluated with Tecan i-control (Software for Tecan Readers Tecan i-control, 1.11.1.0).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 2.64 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % CL: 2.34 - 2.99
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 1.03 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % CL: 0.737 - 1.28
- Details on results:
- After 72 h at termination of the test a dose response relation was observed for the inhibition of growth rate and yield from nominal test item concentrations of 0.305 to 10.0 mg/L. The inhibition of growth peaked in 139.9 % and the inhibition of yield peaked in 101.2 % at a nominal test item concentration of 10.0 mg/L.
The morphology of the algae cells was observed microscopically at test end. The cells were considered normal for the control and up to and including a nominal test item concentration of 0.305 mg/L. Spherical cells were noted at 0.977 and 3.13 mg/L. Additionally for test item concentration 3.13 mg/L less cells were found. No cells were observed at 10.0 mg/L nominal test item concentration.
The growth conditions (pH and temperature) during the test were within the range specified by OECD 201.
The mean light intensity of all positions of the incubator was 88.8 µEm-2s-1 with mean values of each platform in a range from 82.6 to 93.6 µEm-2s-1 (-7.0 % to +5.4 % of mean) which was within ± 15 % of variation as specified by OECD 201. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: 0.971 mg/L - Reported statistics and error estimates:
- The statistical evaluation for the 72 hours period was performed for growth rate and yield using SAS® (2002–2010). A test for normality of the data was performed by calculating the Shapiro-Wilk statistic and the homogeneity of variance of the data was evaluated by calculating the Levene Test. The NOELR and LOELR were determined by using a multiple comparison method (Jonckheere Terpstra test, two tailed, for growth rate, Bonferroni-Holms corrected Welch test, two tailed, for yield). The EC10, 20, 50-values for growth rate and yield were determined by probit analysis following the Gompertz and normal distribution, respectively. Due to statistical reasons inhibition-values above 100 % were set to 100 and values below 0 % were set to zero. Only concentrations within a clear concentration response relation were used for calculations.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EL10-value for growth rate (ErL10) was determined to be 1.03 mg/L (nominal).
The EL50-value for growth rate (ErL50) was determined to be 2.64 mg/L (nominal). - Executive summary:
The study was conducted to determine the effects of the test item on the growth of the single cell green alga Pseudokirchneriella subcapitata, according to OECD 201. Initial target cell densities of 0.5 × 104 cells/mL were employed for the individual replicates. The increase of cell numbers was assessed over a test period of 72 hours. Inhibition of growth was assessed by the determination of NOELR/LOELR and EL10, 20, 50 for growth rate and yield after 72 hours. Following a static GLP range-finding test with nominal test item loading rates of 100, 10.0, 1.00 mg/L and control a static main test with nominal test item loading rates of 10.0, 3.13, 0.977, 0.305, 0.0954 mg/L and control was performed. Six replicates were employed for the control and three for each test item loading rate. The test was performed in 100 mL Erlenmeyer flasks each containing ~ 50 mL test solution. The pH was recorded at test start and test end. Temperature was measured continuously over the whole test period and recorded daily. Light intensity of the continuous illumination was measured at test start. Analytical samples were taken and analysed in the main test from control and all test item loading rates at 0 hours (initial value) from fresh test solutions and after 72 hours from aged test solutions. Where possible NOELR and LOELR were determined by using a multiple comparison method and EL10, 20, 50-values were determined by probit analysis. Biomass: Cell numbers, measured in the controls between 0 h and 72 hours, were found to increase by a factor of 72.86, which exceeds the threshold of 16. It corresponds to a growth rate of 1.42438 d-1. Coefficient of Variation (section by section): The mean coefficient of variation for the section-by-section specific growth rates (hours 0 - 24, 24 - 48 and 48 - 72) in the control cultures was 30 % and did not exceed 35 %. Coefficient of Variation (average growth rate): The coefficient of variation of average growth rate in replicate control cultures was 5.6 % and did not exceed 7 % for the whole test period. The pH-value of the control ranged from 7.38 to 8.19 during the test period, the temperature was measured to be 22.2 – 23.6 °C during the test and the mean light intensity was 88.8 µEm-2s-1 at cell culture level. The measured initial loading rates of amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) ranged from 94 % to 103 % of nominal with a mean initial loading rate of 99 % of nominal. In the aged samples the measured loading rates were between 92 % and 104 % of nominal with a mean measured loading rate of 98 % of nominal. Toxicological endpoints were evaluated using the nominal loading rates of the test item. The EL10-value for growth rate (ErL10) was determined to be 1.03 mg/L (nominal). The EL10-value for yield (EyL10) was 0.572 mg/L (nominal). The EL50-value for growth rate (ErL50) was determined to be 2.64 mg/L (nominal). The EL50-value for yield (EyL50) was 1.23 mg/L (nominal).
Reference
The measured initial loading rates of amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) ranged from 94 % to 103 % of nominal with a mean initial loading rate of 99 % of nominal. In the aged samples the measured loading rates were between 92 % and 104 % of nominal with a mean measured loading rate of 98 % of nominal. Toxicological endpoints were evaluated using the nominal loading rates of the test item.
Table 1. Main Test: % Inhibition of Growth Rate
% Inhibition of Growth Rate | |||
Loading Rate (mg/L) | 0 h - 24 h | 0 h - 48 h | 0 h - 72 h |
Control | -31.3 14.1 -41.8 24.4 5.6 28.9 |
-8.5 1.4 -13.5 7.7 4.3 8.5 |
-5.3 2.0 -6.3 -2.4 4.0 7.9 |
Mean | 0.0 | 0.0 | 0.0 |
0.0954 | 2.4 30.6 -17.8 |
-0.5 18.0 -4.5 |
3.9 8.2 0.8 |
Mean | 5.1 | 4.3 | 4.3 |
0.305 | -36.0 -26.4 -32.9 |
-20.5 -10.8 -19.4 |
-8.9 -2.9 -7.5 |
Mean | -31.8 | -16.9 | -6.4 |
0.977 | -31.5 23.4 1.7 |
-6.5 0.6 3.2 |
8.2 12.4 11.7 |
Mean | -2.1 | -0.9 | 10.8 |
3.13 | 85.0 -22.9 73.1 |
82.4 29.0 37.2 |
84.5 48.7 51.1 |
Mean | 45.1 | 49.5 | 61.5 |
10.0 | 184.6 125.4 125.4 |
101.2 172.9 157.1 |
143.8 135.9 - |
Mean | 145.1 | 143.8 | 139.9 |
Table 2. Determined loading rate of amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1)
Test Item Nominal (mg/L) | Sampling Time Point | Concentration (mg/L) | % of nominal |
Control | 0 h fresh 72 h aged |
< LOD < LOD |
- - |
0.0954 | 0 h fresh 72 h aged |
0.0981 0.0946 |
103 99 |
0.305 |
0 h fresh 72 h aged |
0.304 0.294 |
100 06 |
0.977 |
0 h fresh 72 h aged |
0.920 0.897 |
94 92 |
3.13 |
0 h fresh 72 h aged |
3.22 3.10 |
103 99 |
10.0 |
0 h fresh 72 h aged |
9.62 10.4 |
96 104 |
Description of key information
72 h ErL50 = 2.64 mg/L, 72 h ErL10 = 1.03 mg/L; OECD 201 (Pseudokirchneriella subcapitata); Schuster, 2018
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 2.64 mg/L
- EC10 or NOEC for freshwater algae:
- 1.03 mg/L
Additional information
OECD 201 (2018): A study was conducted to determine the effects of the test item on the growth of the single cell green alga Pseudokirchneriella subcapitata, according to OECD 201. Initial target cell densities of 0.5 × 104 cells/mL were employed for the individual replicates. The increase of cell numbers was assessed over a test period of 72 hours. Inhibition of growth was assessed by the determination of NOELR/LOELR and EL10, 20, 50 for growth rate and yield after 72 hours. Following a static GLP range-finding test with nominal test item loading rates of 100, 10.0, 1.00 mg/L and control a static main test with nominal test item loading rates of 10.0, 3.13, 0.977, 0.305, 0.0954 mg/L and control was performed. Six replicates were employed for the control and three for each test item loading rate. The test was performed in 100 mL Erlenmeyer flasks each containing ~ 50 mL test solution. The pH was recorded at test start and test end. Temperature was measured continuously over the whole test period and recorded daily. Light intensity of the continuous illumination was measured at test start. Analytical samples were taken and analysed in the main test from control and all test item loading rates at 0 hours (initial value) from fresh test solutions and after 72 hours from aged test solutions. Where possible NOELR and LOELR were determined by using a multiple comparison method and EL10, 20, 50-values were determined by probit analysis. Biomass: Cell numbers, measured in the controls between 0 h and 72 hours, were found to increase by a factor of 72.86, which exceeds the threshold of 16. It corresponds to a growth rate of 1.42438 d-1. Coefficient of Variation (section by section): The mean coefficient of variation for the section-by-section specific growth rates (hours 0 - 24, 24 - 48 and 48 - 72) in the control cultures was 30 % and did not exceed 35 %. Coefficient of Variation (average growth rate): The coefficient of variation of average growth rate in replicate control cultures was 5.6 % and did not exceed 7 % for the whole test period. The pH-value of the control ranged from 7.38 to 8.19 during the test period, the temperature was measured to be 22.2 – 23.6 °C during the test and the mean light intensity was 88.8 µEm-2s-1 at cell culture level. The measured initial loading rates of amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) ranged from 94 % to 103 % of nominal with a mean initial loading rate of 99 % of nominal. In the aged samples the measured loading rates were between 92 % and 104 % of nominal with a mean measured loading rate of 98 % of nominal. Toxicological endpoints were evaluated using the nominal loading rates of the test item. The EL10-value for growth rate (ErL10) was determined to be 1.03 mg/L (nominal). The EL10-value for yield (EyL10) was 0.572 mg/L (nominal). The EL50-value for growth rate (ErL50) was determined to be 2.64 mg/L (nominal). The EL50-value for yield (EyL50) was 1.23 mg/L (nominal).
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.