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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- From 2013-05-27 to 2013-07-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- (Adopted:23 March 2006, Annex 5 corrected: 28 July 2011)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances; 2011.03.31, No. 0331-07, Ministry of Health, Labor and Welfare; 2011.03.29 No 5, Ministry of Economy, Trade and Industry; No. 110331009, Ministry of Environment, Japan; IV. Algae growth inhibition test.
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Lot No.: KNC110310
- Purity: 100.0% - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, 100 mg/L
- Sampling method: An aliquot was taken from the remaining unused test solution of each test group at initiation and termination of the test. The samples were taken from mid-depth of each replicate without agitation. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A 0.0802 g aliquot of the test substance was weighed. A stock solution of concentration 100 mg/L was prepared to make a volume to 800 mL with the medium.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular green algae
- Strain: ATCC22662
- Source (laboratory, culture collection): in-house culture originates from American Type Culture Collection (received 01 Aug 1996)
- Method of cultivation: aseptic culture - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 21.7 - 23.5 °C
Measured by Thermometer SK-1250MC (Sato Keiryoki Mfg. Co., Ltd.) - pH:
- 7.6 - 7.7 at the begining
8.1 - 8.3 at the end
Measured by pH meter F-22 (Horiba Ltd.) - Nominal and measured concentrations:
- nominal: 0, 100 mg/L
measured: < LOQ, 100 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 300 mL Erlenmeyer flasks with an air-permeable silicone stopper
- Volume of test solution: 100 mL/vessel
- Aeration: continuously shaken at 100 rpm
- Initial cells density: 1 E+04 cells/mL
- Control end cells density: 1.77 E+06 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
TEST MEDIUM / WATER PARAMETERS
- Standard medium used: yes (OECD 201 recommended test medium)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuous fluorescent illumination
- Light intensity and quality: cool-white light, 400-700 nm, 60-65 µE/m²/s (± 15%) at the surface of the cultures
- Revolution rate: maintained at a constant rate of 100 rpm throughout the exposure period.
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: electronic particle counter after 24, 48 and 72 h
- Appearance: once daily
- Morphological changes: microscopic observation at the end of the test
- Range finding study
- Test concentrations: 0, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: 3.7% inhibition of growth rate at 10 mg/L, 2.3% inhibition of growth rate at 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- meas. (not specified)
- 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:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): not reported
- Unusual cell shape: The microscopic observation of algal cells for morphological changes showed no abnormality at 100 mg/L.
- Colour differences: not reported
- Flocculation: not reported
- Other observations: Appearance of the test solution was clear at the preparation, and no precipitation or floating material was observed during the exposure period.
- Aggregation of algal cells: not reported - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Latest ErC50(0-72h): 1.07 mg/L
- Other: conducted at approximately 6-month intervals. - Reported statistics and error estimates:
- Student t-test, using a computer program (StatLight#3 comparison of 2 groups, ver. 2.0, Yukms Co. , Ltd, Japan).
- Validity criteria fulfilled:
- yes
- Conclusions:
- A 72-hour median effect concentration (ErC50) and no observed effect concentration (NOECr) of test item for freshwater green alga, Pseudokirchneriella subcapitata was >100 and 100 mg/L, respectively, based on the mean measured concentration.
- Executive summary:
The 72-hour median effect concentration (ErC50) and no observed effect concentration (NOECr) of test item for freshwater green alga, Pseudokirchneriella subcapitata were determined in accordance with OECD 201.
The test was conducted with static test system-shake culture (continuous at 100 rpm) for 72 hours at 100 mg/L.
Growth inhibition rate at 100 mg/L was 1.7% after 72-hour exposure. The 72 h ErC50 and NOECr were >100 and 100 mg/L, respectively, based on the mean measured concentration.
Reference
Table 1: Growth inhibition rates
Nominal concentration [mg/L] |
Vessel No. |
Growth rate 0 - 72 h [day -1] |
Percent inhibition [%] |
Medium control |
1 |
1.7337 |
- |
2 |
1.7124 |
- |
|
3 |
1.7293 |
- |
|
4 |
1.7244 |
- |
|
5 |
1.7355 |
- |
|
6 |
1.7213 |
- |
|
Mean |
1.7261 |
- |
|
SD |
0.0086 |
- |
|
CV |
0.5 |
- |
|
100 |
1 |
1.6741 |
3.0 |
2 |
1.7172 |
0.5 |
|
3 |
1.7003 |
1.5 |
|
4 |
1.6884 |
2.2 |
|
5 |
1.7179 |
0.5 |
|
6 |
1.7120 |
0.8 |
|
Mean |
1.7016 |
1.7* |
|
SD |
0.0176 |
- |
* Statistically different
It is considered that the significant difference at 100 mg/L was not the results of the test substance treatment but of incidentally small relative variation between replicates of each test group. Although statistical significance was detected, the difference in the growth inhibition rate between 100 mg/L and control group was very small and was not considered biologically relevant. The statistical significance should be attributed not to the treatment of test substance but to the incidentally small relative variation of the values between replicates in each test group.
Description of key information
The 72-hour median effect concentration (ErC50) and no observed effect concentration (NOECr) of test item for freshwater green alga, Pseudokirchneriella subcapitata were determined in accordance with OECD 201.
The 72 h ErC50 and NOECr were >100 and 100 mg/L, respectively, based on the mean measured concentration.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 100 mg/L
- 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.