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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 835-272-7 | CAS number: 256374-76-2
- 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:
- June 4, 2013 to June 7, 2013
- 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:
- OECD Guidelines for Testing of Chemicals, No.201, March 23, 2006, Annex 5 corrected: July 28, 2011, “Freshwater Alga and Cyanobacteria, Growth Inhibition Test”
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese National Test Guidelines
- Version / remarks:
- "Algal growth inhibition test" stipulated in the "Test Methods of the New Chemical Substances etc." (March 31, 2011, Yakushokuhatsu 0331 No.7, Heisei 23.03.29 Seikyoku No.5, Kanpokihatsu No.110331009, partly amended by Yakushokuhatsu 0402 No.1, Heisei 24.03.28 Seikyoku No.2, Kanpokihatsu No. 120402001 on April 2, 2012)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report.
- Analytical monitoring:
- yes
- Details on sampling:
- The sample taken from the test solution was diluted to make the final composition of methanol/medium (1/1 v/v) to prepare samples for high performance liquid chromatography (HPLC).
- Vehicle:
- no
- Details on test solutions:
- Required amount of the provided substance and the medium were mixed to make a 100 mg/L solution. Then the test solution was prepared by stirring for 48 hours, and then distributed into test vessels.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Species: Pseudokirchneriella subcapitata
Reason for selection of the species: Use of the species is recommended in the test guidelines.
Source of strain: American Type Culture collection
Strain number: ATCC 22662
Acquisition date: June 30, 1995
Keeping organisms after acquisition: Organisms are subcultured in a sterile condition in Kurume Laboratory.
Confirmation of reproducibility of the test system: Algal growth inhibition tests are periodically performed with the reference substance. The latest data is shown below.
Reference substance: potassium dichromate (special grade, Lot No. HLH7646, Wako Pure Chemical Industries, Ltd.)
Test period: From December 10, 2012 to December 13, 2012
ErC50 (days 0-3): 1.2 mg/L
This value was within the determined range of the background data in Kurume Laboratory, which is a range of “mean ± 2 × standard deviation” [mean ± standard deviation: 0.93 ± 0.17 mg/L (n = 21)]. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No post exposure observation period specified
- Hardness:
- Not specified
- Test temperature:
- 21 -24 °C (controlled at ±2 °C)
- pH:
- 7.9
- Dissolved oxygen:
- Not specified
- Salinity:
- Not applicable
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- 100 mg/L nominal
- Details on test conditions:
- Test equipment and apparatus
Test vessel: 500 mL glass Erlenmeyer flask (with an air-permeable stopper, SILICOSEN®)
Culturing apparatus: An apparatus enabling to conduct the culture by continuous shaking and the control of temperature and lighting (constant temperature shaking incubator with illumination, USI Corp.)
Test conditions
Exposure system: Culturing by gyratory shaking (approximately 100 rpm)
Exposure period: 72 hours
Test concentration: 100 mg/L (as a limit test at the upper concentration limit for used test method)
This test concentration was determined based on the result of the preliminary study.
The result of the preliminary study is shown in Additional data.
Control group: Medium without the test substance which was treated by the same preparation method for the test solution.
Number of the replicates: 6 replicates/test group
Volume of the test solution: 600 mL/test group (100 mL/test vessel)
The number of cells at the start of exposure: The number of cells which was pre-cultured for three days from June 1, 2013 to June 4, 2013 was counted, and then inoculated into the test solution to make 0.75 × 104 cells/ml of the cell concentration in the test solution.
Test operation: The test was conducted by aseptic manipulation.
Temperature: 21 -24 °C (controlled at ±2 °C)
Lighting: Nominal value 90 μE/m2/s (within ± 20% of the nominal value, and controlled variance at the mean value ± 15 °C), continuous lighting by fluorescent lamps with a spectrum range of 400 to 700 nm.)
Observation and measurement
Algal growth, etc.
Measurement items: Biomass (cell concentration)
Frequency of measurement: Every 24 hours after the start of exposure (blank correction was performed by measuring a background value for the test solution.)
Observation of cells: One test vessel per each test group was observed at the end of exposure.
Measurement instrument: Coulter Counter Z1, Beckman Coulter, Inc. Biological microscope, BX41, Olympus Co., Ltd.
Condition of the test solution
Condition of the test solution was observed at the start and end of exposure.
Quality of the test solution and exposure environment
pH: The pH of an aliquot from the preparation vessel was measured (at the start of exposure).
The pH values of all test vessels of the test groups were measured because two or more times difference of the biomass and two or more times difference of the growth inhibition rate were observed in the test vessels of the test groups at the end of exposure.
Temperature in incubator: The temperature was measured once per day during exposure period.
Light intensity: The light intensity in the incubator was measured once per day during exposure period.
Instruments: Portable pH meter, HM-21P, TOA D.K.K Certified glass stem thermometer Light quantum meter, LI-250A, LI-COR Inc.
Test substance concentration in the test solution
Frequency of measurement: At the start and end of exposure.
Sampling methods: Separately sampled from the preparation vessel at the start of exposure. An aliquot was sampled from the test vessels of each test group at the end of exposure. Further, the concentrations of the test substance of all test vessels of the test groups were measured because two or more times difference of the biomasses and two or more times difference of the growth inhibition rate were observed in the test vessels of the test groups at the end of exposure.
Removal of algae: Centrifugal separation (3000 rpm for 10 minutes) was conducted only at the end of exposure.
Sample amount: Approximately 50 - 90 mL for the control group, approximately 10 - 90 mL for the test group - Reference substance (positive control):
- not specified
- 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
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Observation of the test solution and measurement results
Conditions of the test solution
The test solutions of the control group and the test concentration group were colorless and transparent at the start of exposure. At the end of exposure, it was green due to cell growth (color of the solution in one vessel of the test concentration group was light green).
Water quality of the test solution and exposure environment
The pH of the test substance was 7.9. The temperatures in the incubator were 21.1 - 21.6 °C and the light intensities were 91 - 96 μE/m2/s.
Test substance concentrations in the test solution
The measured concentrations of the test substance in the test solution were 100 mg/L at the start of exposure and 100 mg/L at the end of exposure (vessel A: 100 mg/L, vessel B: 100 mg/L, vessel C: 99 mg/L, vessel D: 100 mg/L, vessel E: 98 mg/L and vessel F: 100 mg/L).
Further, these concentrations were 101% and 98 - 100% of the nominal concentration, and maintained within ± 20 % of the nominal concentration.
ErC50
ErC50 of the test substance calculated from the growth rates was > 100 mg/L.
Growth curve, cell observation result and NOEC for each test group
Algal growth in the test concentration group showed the similar level of algal growth as in the control group. As a result of cell observation, no abnormality was observed in the control group, and also no abnormality was observed in the test concentration group. As a result of the significance test for growth rates, no statistically significant difference was noted. Based on the results of the significance test and of the above-mentioned observation of the cells, NOEC calculated from growth rates was > 100mg/L.
Discussion
This test was carried out as the limit test to confirm the presence or absence of the effect of the test substance on test organisms at the upper concentration limit (100 mg/L) for used test method.
As a result, algal growth in one test vessel (vessel D) of the 100 mg/L group was remarkably low, and its inhibition rate was 25%. Algal growth in other five vessels showed a similar algal growth to the control group. In the measurement of the pH values and concentrations of the test substance in the test solution for every test vessels at the end of exposure, the measured values of the vessel D showed the similar values to other vessels. Therefore, it was considered that the effect shown in the vessel D was not caused by the test substance. According to these results, any effect on the test organisms was not observed, and it was considered that the test substance did not affect the test organisms at the upper concentration limit (100 mg/L) for used test method.
The test substance concentration in the test solution was maintained ± 20% of the nominal concentration, and the environmental conditions were within the proper range for the test. Therefore, it was considered that this study was in accordance with this test method. - Results with reference substance (positive control):
- Not required
- Reported statistics and error estimates:
- See "Any other information" for details
- Validity criteria fulfilled:
- yes
- Conclusions:
- EC50 (ErC50) > 100 mg/L
NOEC (growth rate, days 0-3) > 100 mg/L
(These concentrations are based on the nominal value.) - Executive summary:
Test organism: Pseudokirchneriella subcapitata
Test groups: 100 mg/L group and a control group
Preparation of test solutions: Prepared by mixing the test substance and the medium and then stirring for 48 hours.
Exposure system: Culturing by gyratory shaking (approximately 100 rpm)
Exposure period: 72 hours
Number of replicates: 6 replicates per test group
Volume of the test solution: 600 mL per test group (100 mL per test vessel)
Incubation temperature: 21.1 – 21.6 °C
Light intensity: 91 – 96 μE/m2/s
Measurement of biomass: Cell concentration
Analysis of the test substance in test solutions: HPLC method (at the start and end of exposure)
Test result
EC50 (ErC50) > 100 mg/L
NOEC (growth rate, days 0-3) > 100 mg/L
(These concentrations are based on the nominal value.)
Reference
pH of test solutions
Nominal concentration (mg/L) |
pH |
|
At the start |
At the end |
|
Control |
7.9 |
7.9 |
100 |
7.9 |
No.A:7.9, No.B:7.9; No.C:7.9, No.D:7.9, No.E:7.9, No.F:7.9 |
Culture temperature and light intensity in incubator
Time |
At the start |
1-day |
2-day |
At the end |
Culture temperature (°C) |
21.6 |
21.1 |
21.5 |
21.3 |
Light intensity (µEm2/s) |
96 |
92 |
91 |
93 |
Value of Biomass at each time
Nominal concentration (mg/L) |
No. |
Cell concentration (x104cells/mL) |
|||
0 houra |
24 hours |
48 hours |
72 hours |
||
Control |
A B C D E F |
0.75 0.75 0.75 0.75 0.75 0.75 |
3.3 4.1 4.2 4.2 3.8 3.6 |
14 18 20 16 20 15 |
54b 81 87 65 80 59 |
Mean S.D. |
0.75 0 |
3.9 0.35 |
17 2.6 |
71 14 |
|
100 |
A B C D E F |
0.75 0.75 0.75 0.75 0.75 0.75 |
4.1 4.3 3.9 3.0 3.5 4.3 |
21 17 20 8.8 16 19 |
96 59 85 22 68 86 |
Mean S.D. |
0.75 0 |
3.9 0.52 |
17 4.5 |
69 26 |
aThe value based on the measured value of pre-culture
bThe minimum cell growth in control (biomass at the end of exposure / biomass at the start of exposure) 54 / 0.75 = 72
Growth rate and growth inhibition
Nominal concentration (mg/L) |
No. |
Growth rate (0-3d) |
Inhibition rate (%) |
Control |
A B C D E F |
1.42 1.56 1.59 1.49 1.55 1.45 |
- - - - - - |
Mean S.D. |
1.51 0.0651 |
- - |
|
100 |
A B C D E F |
1.62 1.46 1.58 1.13 1.50 1.58 |
-6.9 3.6 -4.2 25 0.66 -4.5 |
Mean S.D. |
1.48 0.178 |
2.3 12 |
ErC50 and NOEC
ErC50 (mg/L) |
NOEC (mg/L) |
>100 |
≥ 100 |
Result of statistical analysis
Nominal concentration (mg/L) |
Statistical analysis |
Statistical procedure |
100 |
n.s. |
F test Aspin-Welch t-test |
n.s.: no significant difference
Variation of growth rate in control
Variation for section-by-section specific growth rates in the controls
Control No. |
Mean |
Standard deviation |
Coefficient of variation (%) |
|
A |
1.42 |
0.0749 |
5.3 |
8.6 (Mean) |
B |
1.56 |
0.121 |
7.8 |
|
C |
1.59 |
0.130 |
8.2 |
|
D |
1.49 |
0.198 |
13 |
|
E |
1.55 |
0.157 |
10 |
|
F |
1.45 |
0.103 |
7.1 |
Variation of average specific growth rates in replicate controls
|
0-3 day |
Mean |
1.51 |
Standard deviation |
0.0651 |
Coefficient of variation (%) |
4.3 |
Description of key information
EC50 (ErC50) > 100 mg/L
NOEC (growth rate, days 0-3) > 100 mg/L
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 100 mg/L
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
Test organism: Pseudokirchneriella subcapitata
Test groups: 100 mg/L group and a control group
Preparation of test solutions: Prepared by mixing the test substance and the medium and then stirring for 48 hours.
Exposure system: Culturing by gyratory shaking (approximately 100 rpm)
Exposure period: 72 hours
Number of replicates: 6 replicates per test group
Volume of the test solution: 600 mL per test group (100 mL per test vessel)
Incubation temperature: 21.1 – 21.6 °C
Light intensity: 91 – 96 μE/m2/s
Measurement of biomass: Cell concentration
Analysis of the test substance in test solutions: HPLC method (at the start and end of exposure)
Test result
EC50 (ErC50) > 100 mg/L
NOEC (growth rate, days 0-3) > 100 mg/L
(These concentrations are based on the nominal value.)
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.