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EC number: 819-930-0 | CAS number: 37288-51-0
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- August 1992 to November 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Given the similarity between the two enzymes, this study can be used as read-across for licheninase.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- Method: The test substance was dissolved in sterile nutrient medium to give an initial stock solution of 200 mg/L. This stock solution was further diluted with sterile nutrient medium to produce a series of solutions exactly twice the concentration of the intended exposure levels. 150 mL of algal preculture was mixed with 150 mL of each of these solutions to give final test series.
- Controls: medium. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: green alga
- Strain: CCAP 276/20
- Source (laboratory, culture collection): Culture Centre of Algae & Protozoa c/o Freshwater Biological Association, Cumbria, UK
- Method of cultivation:
Pre-culture: Sterile nutrient medium was inoculated from a master culture and incubated under continuous illumination (ca. 7000 lux) and stirring (orbital shaker) at 24 ± 1°C to give an algal suspension in log phase growth.
Culture conditions: Conical flasks each containing 100 mL test or control culture were loosely stoppered and placed at random in a Gallenkamp Illuminated Orbital Incubator. The cultures were incubated, without media renewal for 72 hours under continuous illuminatioon of approximately 7000 lux. The temperature was maintained at 24 ± 1°C and gaseous exchange and suspension of the algal cells was ensured by the action of the orbital shaker oscillating at 100 cycles per minute. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 23.9 - 24.2°C
- pH:
- 7.5 - 10.2
- Nominal and measured concentrations:
- Nominal: 0, 6.25, 12.5, 25, 50 and 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Conical flasks (250 mL)
- Type (delete if not applicable): loosely stoppered
- Material, size, fill volume: glas, 250 mL, 100 mL
- Initial cells density: 8.2*10^4 cells/mL
- Control end cells density: 2.4*10^6 cells/mL
- No. of vessels per concentration (replicates): 3
- 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 water
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous illumination
- Light intensity and quality: 7000 lux provided by 7 x 30 W "warm white" 1 metre fluorescent tubes
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Samples were taken at 0, 24, 48 and 72 hours and the absorbance measured at 665 nm using 4 cm cell path cuvettes in a Cecil 373 Series 2 Spectrophotometer. The cell densities of the control cultures at initiation and at termination were determined by direct counting with the aid of a haemocytometer (Improved Neubauer).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Test concentrations: 6.25, 12.5, 25, 50 and 100 mg/L - Reference substance (positive control):
- no
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 24 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks on result:
- other: 95% CL 22-26 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- active enzyme protein
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 49 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL 42-57 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- active enzyme protein
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 12.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- active enzyme protein
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- active enzyme protein
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): There were no abnormalities in the control cultures or any of the test cultures apart from the two highest exposure levels (50 and 100 mg/L), where cells were observed to be smaller than average and clumped.
- Any stimulation of growth found in any treatment: no - Validity criteria fulfilled:
- yes
- Conclusions:
- Alpha-amylase is inhibitory to the growth of Desmodesmus subspicatus at concentrations in excess of 12.5 mg/L corresponding to 1.3 mg active enzyme protein (aep)/mL. The EbC50 (72h) value is 24 mg/L and the ErC50 (24-72h) is 49 mg/L corresponding to 2.5 and 5.2 mg aep/L, respectively.
- Executive summary:
A study was conducted to assess the inhibitory effect of alpha-amylase on the growth of the unicellular green alga Desmodesmus subspicatus, Strain No. CCAP 276/20.
The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 201 and EEC Methods for the Determination of Ecotoxicity, EEC Directive 67/458 Annex VIII, Part C (87/302/EEC).
Algal cultures exposed to five test concentrations of alpha-amylase plus one untreated control were incubated on an orbital shaker under continuous illumination at 24 ± 1°C for 72 hours. Growth was monitored daily by measuring the absorbance of each culture at 665 nm.
The following values were derived from the data:
EbC50(72h): 24 mg/l corresponding to 2.5 mg active enzyme protein (aep)/L
ErC50(24-72h): 49 mg/l corresponding to 5.2 mg aep/L
NOEC 72h for AUC (Area under the curve): 12.5 mg/L corresponding to 1.3 mg aep/L
NOEC for the 24 -72 hour growth rate: 25 mg/L corresponding to 2.6 mg aep/L
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 19 September 2016 to 27 September 2016
- 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:
- 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Deviations:
- no
- Principles of method if other than guideline:
- Only nominal concentrations.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name: Licheninase
Batch nr.: PPB41588
Received: 18 July 2016
Condition: Frozen - Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Dilution in media
- Controls: ISO medium - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular green algae
- Strain: Pseudokirchneriella subcapitata
- Source (laboratory, culture collection): MicroBiotests Inc. The algal growth inhibition bioassay has been developed by the research teams at the Laboratory for Biological Research in Aquatic Pollution (LABRAP) at the University of Ghent in Belgium.
- Method of cultivation: No culturing, the Algaltoxkit makes use of microalgae which are immobilised in a special matrix in which they survive for several months without losing their viability. After de-immobilization and transfer into an adequate algal culturing medium, the microalgae resume their growth immediately. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- According to the formula of the OECD Guideline 201 "Alga, Growth Inhibition Test" and the ISO/DIS Guideline 8692 "Water Quality - Freshwater Algal Growth Inhibition Tests with Unicellular Green Algae".
- Test temperature:
- 23 ± 2°C
- pH:
- Within limits.
- Dissolved oxygen:
- Not measured.
- Nominal and measured concentrations:
- The algae were exposed for 72 hours to the following nominal concentrations of the test substance: 6.25, 12.5, 25, 50 and 100 mg TOS/L.
- Details on test conditions:
- A 72h algal growth inhibition test is performed in long cell test vials with Pseudokirchneriella subcapitata. Algae are supplied as de-immobilized algal beads. The Algal toxkit test follows the prescriptions of the OECD "Algal growth inhibition test" (Guideline 201) and the ISO "Water Quality - Freshwater Algal Growth Inhibition Tests with Unicellular Green Algae" (ISO Standard 8692).
Endpoint of the study is inhibition of algal growth rate.
The algae were exposed for 72 hours to the below concentrations of the test substances at the dose concentrations of 6.25, 12.5, 25, 50 and 100 mg TOS/L.
Algal cell density was measured after 24, 48 and 72 h exposure with a spectrophotometer at a wavelength of 670 nm and algal growth rate calculated according to ISO Standard 8692.
TEST SYSTEM
- Test vessel: 25 mL calibrated flask
- Material, size, headspace, fill volume: 25 mL
- Initial cells density: 1*10^4 algae/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes.
- Detailed composition if non-standard medium was used: According to the formula of the OECD Guideline 201 "Alga, Growth Inhibition Test" and the ISO/DIS Guideline 8692 "Water Quality - Freshwater Algal Growth Inhibition Tests with Unicellular Green Algae".
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 72 h
- Light intensity and quality: 10000 lux for sideway illumination or min. 3000-4000 lux for bottom illumination
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Spectrophotometer (670 nm). - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: mg TOS/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 12.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 other: mg TOS/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 12.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Details on results:
- No significant growth inhibition and no abnormalities were observed.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Licheninase batch PPB41588 was not toxic to Pseudokirchneriella subcapitata as no significant growth inhibition was observed up to a concentration of 100 mg TOS/L. Thus, no 72h ErC50 could be calculated, and should be >100 mg TOS/L (>12.2 mg aep/L).
- Executive summary:
A 72h algal growth inhibition test is performed in long cell test vials with Pseudokirchneriella subcapitata. Algae are supplied as de-immobilized algal beads. The Algal toxkit test follows the prescriptions of the OECD "Algal growth inhibition test" (Guideline 201) and the ISO "Water Quality - Freshwater Algal Growth Inhibition Tests with Unicellular Green Algae" (ISO Standard 8692).
Endpoint of the study is inhibition of algal growth rate.
Average specific growth rate = ErC50 (0 - 72 h).
“No observed effect concentration”.
The algae were exposed for 72 hours to the below concentrations of the test substances.
Test compound
Exposure concentration mg TOS /L
5
4
3
2
1
Licheninase, batch PPB41588
100
50
25
12.5
6.25
Algal cell density was measured after 72 h exposure with a spectrophotometer at a wavelength of 670 nm and algal growth rate calculated according to ISO Standard 8692.
Test substances
ErC50 (72h) Concentration in
mg TOS/L
NOEC (72h) Concentration in
mg TOS/L
Licheninase, batch PPB41588
n.d
>100
n.d.: not detected
Conclusion:
Licheninase batch PPB41588 was not toxic to Pseudokirchneriella subcapitata as no significant growth inhibition was observed up to a concentration of 100 mg TOS/L. Thus, no 72h ErC50 could be calculated, and should be >100 mg TOS/L (>12.2 mg aep/L).
Referenceopen allclose all
Description of key information
For algae:
- Licheninase batch PPB41588 was not toxic to Pseudokirchneriella subcapitata as no significant growth inhibition was observed up to a concentration of 100 mg TOS/L. Thus, no 72h ErC50 could be calculated, and should be >100 mg TOS/L (>12.2 mg/L aep).
- Alpha-amylase is inhibitory to the growth of Desmodesmus subspicatus at concentrations in excess of 12.5 mg/L corresponding to 1.3 mg active enzyme protein (aep)/mL. The EbC50 (72h) value is 24 mg/L and the ErC50 (24-72h) is 49 mg/L corresponding to 2.5 and 5.2 mg aep/L, respectively.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 5.2 mg/L
Additional information
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