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EC number: 265-025-3 | CAS number: 64704-23-0
- 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-07-19 to 2011-11-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study from supporting substance (structural analogue)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2006
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cystine
- EC Number:
- 200-296-3
- EC Name:
- Cystine
- Cas Number:
- 56-89-3
- Molecular formula:
- C6H12N2O4S2
- IUPAC Name:
- cystine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Purity test date: >98.5%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, in the dark
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
Sampling and analysis
- Analytical monitoring:
- no
- Remarks:
- Substance specific analysis of the test item in the test medium was not performed. Instead, the dissolved organic carbon (DOC) was measured as an indiciator of the presence of the test item in the test medium.
- Details on sampling:
- - Concentrations: control (test water without test item) and 100 mg test item/L (nominal)
- Sampling method: Substance specific analysis of the test item in the test medium was not performed. Instead, the dissolved organic carbon (DOC) was measured as an indiciator of the presence of the test item in the test medium.
- Sample storage conditions before analysis: All samples were analyzed immediately after sampling without storage
- Duplicate samples: duplicate samples (without algae) were taken from freshly prepared test medium of the single test concentration and the control at test start.
- No 72-hour stability samples were taken, since the measurement of carbon content is not adequate method to determine the stability or instability of the parent test molecule in the test medium.
Test solutions
- Vehicle:
- not specified
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: due to low solubility of test item in test water, a dispersion with the loading rate of 100 mg/L was prepared. 30.0 mg of the test item was dispersed in 300 mL of test water, stirring intensely for 3 hours at room temperature in the dark. After the 3-hour stirring period, the dispersion of the test item (the test item particles were visible) was filtered through a membrane filter (pore size 0.45 um) and the undiluted filtrate was used as test medium.
- Eluate: not specified
- Differential loading: not specified
- Controls: test water without test material
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): none
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): none
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): test item particles were visible after 3-hours stirring but was filtered through a membrane filter.
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata, formerly Selenastrum capricornutum, green algae
- Strain: No. 61.81 SAG
- Source (laboratory, culture collection): Collection of Algal Cultures (SAG, Institute for Plant Physiology, University of Göttingen); cultivated at Harlan Laboratories under standardized conditions according to the test guidelines
- Age of inoculum (at test initiation): inoculum culture was set up 4 days before start of exposure
- Method of cultivation: cultivated under the test conditions; the inoculum culture was diluted threefold one day before the start of the test to ensure that the algae were in the exponential growth phase when used to inoculate the test solutions.
ACCLIMATION
- Acclimation period: not specified
- Culturing media and conditions (same as test or not): same as test
- Any deformed or abnormal cells observed: not specified
CONTROL
- Positive control: Potassium dichromate is tested as a positive control twice a year to demonstrate satisfactory test conditions as well as evaluate the algal quality. The result of the latest positive control test performed in April 2011 showed that the sensitivity of the test system was within the internal historical range (72-hour EC50 for the growth rate: 1.3 mg/L (Harlan Laboratories Study D25712), range of the 72-hour EC50 for the growth rate from 2000 to 2011: 0.71-1.7 mg/L)
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- 24, 48, 72 hours
Test conditions
- Hardness:
- 0.15 mmol/L (=15 mg/L as CaCO3)
- Test temperature:
- 23 °C
- pH:
- 8.1-8.5 (control); 7.9-9.0 (test item)
- Dissolved oxygen:
- not reported
- Salinity:
- not applicable
- Conductivity:
- not reported
- Nominal and measured concentrations:
- 100 mg/L (nominal)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 50 mL Erlenmeyer flasks
- Type (delete if not applicable): closed (covered with a glass dish)
- Material, size, headspace, fill volume: flasks were filled to 15 mL of test solution
- Aeration: not specified
- Renewal rate of test solution (frequency/flow rate): not specified
- Initial cells density: 10,000 cells/mL (nominal)
- Control end cells density: not specified
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes, followed guideline
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water (AAP Medium) prepared according to the test guidelines was used for algal cultivation and testing.
- Total organic carbon: 0.271 mg DOC/L (control)
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH measured at start and end of test; water temperature and appearance recorded daily
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: yes, pH of test water was adjusted to about 10 to enhance the solubility of the test item in the test water as far as possible
- Light intensity and quality: mean 6700 Lux (range 6000 to 7300 Lux, measured at 9 places in the experimental area)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Electronic particle counter (Coulter Counter, Model ZM)
- Growth rate, yield, NOEC, LOEC
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- Justification for using less concentrations than requested by guideline: limit test according to test guidelines due to low solubility of test item
- Range finding study: yes
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC20
- 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:
- 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
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): none
- Unusual cell shape: none
- Colour differences: none
- Flocculation: none
- Adherence to test vessels: none
- Aggregation of algal cells: none
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no, the presence of the test item in the test medium of the single test concentration could be confirmed and the measured DOC-values in the test item treatment correspond to about 98 mg test item/L (based on a C-content of L-Cystine of 30%).
- Effect concentrations exceeding solubility of substance in test medium: 72-hour NOEC was 100 mg/L and the value might be higher but was not tested - Reported statistics and error estimates:
- The test item had no statistically significant inhibitory effect on the growth of the algae during the test period of 72 hours at the loading rate of 100 mg/L (results of Student t-tests, one-sided smaller, α = 0.05)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a 72-hour static test conducted according to the OECD Guideline 201 (2006), the test item, L-Cystine, had no acute toxic effects on the green algal species Pseudokirchneriella subcapitata up the its solubility limit in the test water.
- Executive summary:
The influence of the test item, L-Cystine, on the growth of the freshwater green algal species Pseudokirchneriella subcapitata was investigated in a 72 -hour static test according to the OECD Guideline 201 (2006), C.3 (1992) and the Commission Regulation (EC) No 761/2009, C.3.
A limit test was performed in accordance with the test guidelines to demonstrate that the test item has no toxic effect on the algae up to the solubility limit of the test item in the test water.
Due to the low water solubility of the test item, a dispersion of the test item with the loading rate of 100 mg/L was prepared. A control group (test water without test item) was tested in parallel.
Since a filtrate was tested and no substance-specific analytical measurements were performed, the biological results are based on the loading rate of the test item.
At the loading rate of 100 mg/L, the algal growth (average growth rate and yield) was not inhibited (but enhanced) compared to the control after 72 hours of test duration. The EC50 and LOEC were both >100 mg test item/L and the NOEC was ≥100 mg test item/L. In conclusion, the test item, L-Cystine, had no acute toxic effects on the test organism up to its solubility limit in the test water under the present test conditions.
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