Registration Dossier
Registration Dossier
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: 232-650-8 | CAS number: 9002-07-7
- 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

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:
- 28-03-2017 to 05-01-2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- For industrial enzymes, the PNEC (predicted no effect concentration) value for enzymes in general is considered the highest dose tested for a given endpoint in studies conducted and published by the enzyme industry. The one exception is for some proteases and oxidoreductases, where effects may be observed at lower concentrations. Similarly, although the algal growth inhibition study with sedolisin was not conducted GLP, the 48-hour algal growth inhibitory effect concentration (EC50) for sedolisin was greater than the limit dose of 100 mg/L. The weight-of-evidence indicates that enzymes in general are not or of very low ecotoxicity.
Due to the similarity between the two enzymes, similar results are expected for trypsin. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- 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
- Remarks:
- See *justification for type of information'
- Analytical monitoring:
- no
- Details on sampling:
- - Concentrations: 10, 30, 50, 70, 100 TOS mg/L.
- Vehicle:
- no
- Details on test solutions:
- According to the MicroBiotests Inc SOP.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella 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: According to the MicroBiotests Inc. SOP.
Algae are supplied as de-immobilized algal beads. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 23°C +/- 2 °C
- pH:
- 8.1 +/- 0.2
- Dissolved oxygen:
- Media was saturated with air before use
- Nominal and measured concentrations:
- Nominal concentrations
- Details on test conditions:
- 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: As described in OECD Guideline 201and the ISO/DIS Guideline 8692.
OTHER TEST CONDITIONS
- Sterile test conditions: 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 - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 24.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- 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
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 10 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.:
- > 2.5 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:
- Endopeptidase, batch PPF38268 was tested in concentrations 10, 30, 50, 70, 100 TOS mg/L. It was found to inhibit growth rate at all concentrations tested after 72h exposure, whereas no significant inhibition was observed after 24 and 48h exposure. Inhibition of the growth rate at 72h was found to be approximately 3% at 10 mg TOS/L, 34 % at 30 mg TOS/L, 30% at 50 mg TOS/L, and 12 % at 100 mg TOS/L indicating only slightly toxicity towards algal growth. There was no dose-response relationship and because of the low observed toxicity towards algal growth no ErC50 value could be estimated and must be > 100 mg TOS/L (> 24.7 mg aep/L). The NOEC value was determined to be < 10 mg TOS/L (< 2.5 mg aep/L).
- Executive summary:
The purpose of this study was to screen for toxicity of endopeptidase, batch PPF38268 towards algae. A 72h algal growth inhibition test was performed in long cell test vials with Pseudokirchneriella subcapitata. Algae are supplied as de-immobilized algal beads. The Algal tox kit 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 percent inhibition (I%) of algal growth rate compared to the control.
IC50: Calculated/estimated 50% growth inhibition compared to control algae.
Endopeptidase, batch PPF38268 was found to inhibit growth rate at all concentrations tested after 72h exposure, whereas no significant inhibition was observed after 24 and 48h exposure. Inhibition of the growth rate at 72h was found to be approximately 3% at 10 mg TOS/L, 34 % at 30 mg TOS/L, 30% at 50 mg TOS/L, and 12 % at 100 mg TOS/L indicating only slightly toxicity towards algal growth. There was no dose-response relationship and because of the low observed toxicity towards algal growth no ErC50 value could be estimated and must be > 100 mg TOS/L (> 24.7 mg aep/L). The NOEC value was determined to be < 10 mg TOS/L (< 2.5 mg aep/L).
Reference
Description of key information
The toxicity of trypsin in algae was not tested, however, an enzyme from the same sub-subclass - sedolisin - was tested.
There was no dose-response relationship and because of the low observed toxicity towards algal growth no ErC50 value could be estimated and must be > 100 mg TOS/L (> 24.7 mg aep/L). The NOEC value was determined to be < 10 mg TOS/L (< 2.5 mg aep/L). Due to the similarity between the two enzymes, similar results are expected for trypsin.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 2.5 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.
