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EC number: 232-983-9 | CAS number: 9075-68-7
- 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
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1995-02-09 to 1995-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Non-proteolytic enzymes are in general of low to non toxicity towards aquatic organisms and since the enzyme belongs to the same sub-subclass as pullulanase i.e 3.2.1, it can be considered very similar to pullulanase . Thus read-across is fully applicable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- change of study monitor in april 1995
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate included in study report
Test material
- Reference substance name:
- Active enzyme protein of alpha-amylase (EC no. 232-565-6, CAS no. 9000-90-2, EC name: Amylase, alpha-, Enzyme Class No.: 3.2.1.1)
- Molecular formula:
- Not available
- IUPAC Name:
- Active enzyme protein of alpha-amylase (EC no. 232-565-6, CAS no. 9000-90-2, EC name: Amylase, alpha-, Enzyme Class No.: 3.2.1.1)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Lot/batch No.: PPY 5067
- Expiration date of the lot/batch: 1997-01-01
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature and at 4 degree Celcius.
- Storage condition of test material: in the refrigerator at 4⁰C.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0 and 100 mg test substance/L
- Sampling method: Duplicate samples from freshly prepared test media of the control and from the test concentration of 100 mg test substance/L were taken at the start of the test, after 24h just after the first test medium renewal and at the end of the test at 96h.
- Sample storage conditions before analysis: Samples were stored deep-frozen at -20°C
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:The test medium was prepared by dissolving a weighed amount of the test substance directly in the test water in the aquarium. The test media was prepared just before introduction of fish.
- Controls: test water
Test organisms
- Test organisms (species):
- other: Oncorhynchus mykiss Walbaum
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Strain: Oncorhynchus mykiss Walbaum
- Source: Forellenhof Fredelsloh, Moringen, Germany
- Length at study initiation (length definition, mean, range and SD): 5.5 ± 0.11 cm
- Weight at study initiation (mean and range, SD): 2.0 ± 0.15 g
ACCLIMATION
- Acclimation period: 12 weeks
- Type and amount of food: commercial trout diet (Alleinfutter für Forellenbrut, Aminostart (extr.), Kraftfutterwerk Wesel GmbH, Wesel, Germany)
- Health during acclimation (any mortality observed): At least during the last three weeks prior to the start of the test no fish diet in the test fish batch
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 2.10 mmol/L (= 210 mg/L as CaCO3)
- Test temperature:
- 13.1 - 14.6 °C
- pH:
- 7.7 - 8.8
- Dissolved oxygen:
- 8.1-10.4 mg/L
- Nominal and measured concentrations:
- nominal: 0 and 100 mg/L
measured: fresh samples were between 95.2 and 107.9% of the nominal value
test media taken at the end of the 24 hour renewal periods were between 90.2 and 91.2 % of the nominal value
- Details on test conditions:
- TEST SYSTEM
- Test vessel: aquarium
- Fill volume: 30 L test medium
- Aeration: slightly
- Renewal rate of test solution (frequency/flow rate): 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water of the community Rossdorf; before use the total hardness was reduced in the laboratories of RCC and the water filtered through an activated carbon filter.
- Alkalinity: 4.60 mmol/L
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light per day,
- Light intensity: appr. 50 - 300 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were observed after 2, 24, 48, 72 and 96 hours test duration for symptoms of intoxication and mortality.
TEST CONCENTRATIONS
- Range finding study
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 58.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Remarks:
- active enzyme protein
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: no
- Mortality of control: 0
- Other adverse effects control: no
- Abnormal responses: no
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The No-observed-effect concentration was the highest exposure concentration of 100 mg test material/L corresponding to 58.3 mg active enzyme protein/L.
- Executive summary:
The acute toxicity of alpha-amylase to Rainbow Trout (Oncorhynchus mykiss) was determined in a 96‑hour semi-static test with a daily test medium renewal according to the OECD Guideline No. 203 and in compliance with GLP.
A limit test was performed to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/L corresponding to 58.3 mg active enzyme protein (aep)/L. The analysis of the exposure concentrations revealed that the test substance concentrations were within the range of 80 to 120% of the nominal value and thus the biological results are based on the nominal concentration of the test substance.
The 96h NOEC was determined to be 100 mg/L corresponding to 58.3 mg aep/L. The 96h LC50 value could not be determined due to the absence of toxicity of the test substance but is clearly higher than 100 mg/L (58.3 mg aep/L).
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