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Diss Factsheets
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EC number: 232-877-2 | CAS number: 9032-08-0
- 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
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:
- 20 December 2005 - 02 November 2006
- 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
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 227.9 mg enzyme concentrate dry matter/L
- Sampling method: Triplicate samples, of 5 ml, were taken from control and the test stock solution (including the “no
algae” level) at 0 hours and from culture vessels at 72 hours (replicates pooled) for analysis. The samples were not filtered to remove algal cells before analysis. Additional samples were taken from flasks containing the “no algae” cultures at 72 hours (replicates pooled).
- Sample storage conditions before analysis: frozen at - 20°C in the dark - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A sample of the test material weighing 1584 mg was dispersed directly in 1 litre of algal medium to give the nominal test concentration of 227.9 mg enzyme concentrate dry matter/L.
- Controls: medium. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: CCAP 278/4
- Source (laboratory, culture collection): Culture Collection of Algae & Protozoa, SAMS Research Services Ltd, Argyll, Scotland. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 24°C
- pH:
- 7.2 - 7.9
- Nominal and measured concentrations:
- A preliminary range finding study was conducted with nominal test concentrations of 1.04, 10.4, 103.6 and 227.9 mg enzyme concentrate dry matter/L.
Definitive study:
Nominal: 227.9 mg enzyme concentrate dry matter/L
Measured: 238.3 mg enzyme concentrate dry matter/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: conical flask
- Type (delete if not applicable): loosely stoppered
- Material, size, headspace, fill volume: glass, 250 mL, fill volume:100 mL
- Initial cells density: control: 12087 cells/mL; 220 mg TOS/L: 15073 cells/mL
- Control end cells density: 1348333 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reverse osmosis purified/deionised water
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous illumination
- Light intensity and quality: 7350-7540 Lux provided by fluorescent tubes
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter] samples were taken at 24, 48 and 72 hours and the cell densities determined by direct counting using a haemacytometer (Improved Neubauer). Cell densities at 0 hours were to low to be counted using a haematocytometer and therefore estimation was conducted using a Coulter® Multisizer II particle counter.
TEST CONCENTRATIONS
- Preliminary test: Nominal test concentrations of 1.0, 10, 100 and 220 mg TOS/L.
- Results used to determine the conditions for the definitive study: yes
- Test concentrations in definitive study: 220 mg TOS/L - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 227.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: enzyme concentrate dry matter
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 227.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: enzyme concentrate dry matter
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no
- Any stimulation of growth found in any treatment: no - Validity criteria fulfilled:
- yes
- Conclusions:
- Glucoamylase, batch PPY24900 did not inhibit the growth of Pseudokirchneriella subcapitata, Strain No. CCAP 278/4 at a concentration of 227.9 mg enzyme concentrate dry matter/L under the conditions of this test.
Both ErC50 and EbC50 (0 - 72 hours) were > 227.9 mg enzyme concentrate dry matter/L (equivalent to > 103.7 mg active enzyme protein/L).
The no-observed-effect concentration NOEC was 227.9 mg enzyme concentrate dry matter/L (equivalent to 103.7 mg active enzyme protein/L). - Executive summary:
A study was conducted to assess the inhibitory effect of Glucoamylase, batch PPY24900 on the growth of the unicellular green alga Pseudokirchneriella subcapitata, Strain No. CCAP 278/4. Six algal cultures, with an initial cell count of approximately 1 x 104 cells/mL, were exposed to Glucoamylase, batch PPY 24900 at a nominal test concentration of 227.9 mg enyzme concentrate dry matter/L. Mean measured concentration was 238.4 mg enzyme concentrate dry matter/L. These cultures, together with an untreated control group of six replicates, were incubated in a Gallenkamp illuminated orbital incubator under continuous illumination at temperatures in the range of 24 ± 1°C for 72 hours. Cell numbers were counted daily to monitor growth.
Verification of test concentrations was performed based on enzyme activity. The amount of measured enzyme (activity/g) was then converted to mg enzyme concentrate dry matter/L in order to calculate the achieved measured concentrations. Mean measured concentrations ranged from 119% of nominal at 0 hours (fresh), 92.5% at 72 hours (expired). The samples contaning no algae ranged from 120% at 0 hours (fresh, no algae), and 70% at 72 hours (expired, no algae). In the ‘no algae’ flasks it is considered that enzyme exposure to light energy would be greater with no algal cells to absorb light resulting in further enzyme degradation.
Glucoamylase, batch PPY24900 did not inhibit the growth of Pseudokirchneriella subcapitata, Strain No. CCAP 278/4 at a concentration of 227.9 mg enzyme concentrate dry matter/L under the conditions of this test.
Both ErC50 and EbC50 (0 - 72 hours) were > 227.9 mg enzyme concentrate dry matter/L (equivalent to > 103.7 mg active enzyme protein/L).
The no-observed-effect concentration NOEC was 227.9 mg enzyme concentrate dry matter/L (equivalent to 103.7 mg active enzyme protein/L).
Reference
Description of key information
Glucoamylase, batch PPY24900 did not inhibit the growth of Pseudokirchneriella subcapitata, Strain No. CCAP 278/4 at a concentration of 227.9 mg enzyme concentrate dry matter/L under the conditions of this test.
Both ErC50 and EbC50 (0 - 72 hours) were > 227.9 mg enzyme concentrate dry matter/L (equivalent to > 103.7 mg active enzyme protein/L).
The no-observed-effect concentration NOEC was 227.9 mg enzyme concentrate dry matter/L (equivalent to 103.7 mg active enzyme protein/L).
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 103.7 mg/L
Additional information
NOEC based on active enzyme protein.
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.
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