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EC number: 805-156-0 | CAS number: 137010-42-5
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.17 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1.7 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.017 µg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 65 000 µg/L
- Assessment factor:
- 1
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- no exposure of sediment expected
Sediment (marine water)
- Hazard assessment conclusion:
- no exposure of sediment expected
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 568 µg/kg soil dw
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
The aquatic toxicity data were obtained from short term toxicity studies in species representing three trophic levels (i.e. algae, crustacean and fish).
Fish: Glutamyl endopeptidase has not been tested in fish, however, a similar enzyme - subtilisin belonging to the same enzyme sub-subclass - has been tested in rainbow trout for 96 hours. The 96-hour LC50 value for subtilisin was nominally 17.7 mg TOS/L, with 95% confidence limits of 13.3 and 23.5 mg TOS/L. Based on the initial measured levels, the 96-hour LC50 was 14.6 mg TOS/L (95% confidence limits, 10.6 and 19.9 mg TOS/L) corresponding to 8.2 mg aep/L. The no-observed-effect concentration (NOEC) was not clearly identified during the definitive test but based on the findings of a range finding test, the NOEC was 10 mg TOS/L (nominal) corresponding to 4.6 mg aep/L. Due to the similarity between the two enzymes, similar results are expected for glutamyl endopeptidase.
Daphnia: Glutamyl endopeptidase was tested in Daphnia magna in a supporting study. The test revealed an 48h EC50 value of 5 mg TOS/L. The NOEC (48h) was determined to be 4.6 mg/L.
Another similar proteolyticenzyme – subtilisin belonging to the same enzyme sub-subclass– was tested using Daphnia magna. The EC value was 0.306 mg TOS/L (95% confidence limits, 0.23 and 0.429 mg TOS/L), and NOEC was 0.066 mg TOS/L (measured concentrations).
Algae: Glutamyl endopeptidase batch PPA 27269 was tested with Pseudokirchneriella subcapitata. It inhibited algal growth at 10 mg TOS/L, whereas no inhibitory effect was detected at lower concentrations. The inhibitory effect at 10 mg TOS/L was below 50% and thus no ErC values could be determined. The NOEC was determined to be 1 mg TOS/L.
Another similar enzyme - subtilisin – was tested with Pseudokirchneriella subcapitata. The 72-hour ErC50 was 1.48 mg TOS/L corresponding to 830 µg aep/L. The NOEC was 0.566 mg TOS/L.
Inhibition control carried out with non-proteolytic enzymes in the test of ready biodegradability showed no inhibition of the activated sludge inoculum at an enzyme concentration above the expected levels in inlet to sewage treatment plants (STPs). Monitoring of enzymes in the inlet to municipal STPs (in Denmark) resulted in concentrations of less than 2 µg active enzyme protein (aep)/L which are below the initial concentration used in tests for ready biodegradability, where no inhibitory effects were observed. It is concluded that a study on activated sludge respiration inhibition does not need to be conducted. Therefore, the test enzyme is not considered to be toxic to microorganisms.
The EC50 for a similar enzyme to glutamyl endopeptidase, subtilisin, was 0.86 mg active enzyme protein/L was used for PNEC derivation and the assessment factors 1000 and 10000 were applied for fresh and marine water, respectively.
The PNEC value for STP is based on actual measurements of enzyme concentration in STP connected to manufacturing site. Up to 65000 µg aep/L were detected in STP connected to manufacturing site and since there was no negative impact observed, this concentration is the estimated PNEC value for STP.
PNEC values for sediment exposure have not been derived because the enzyme is readily biodegradable, highly water soluble and has a very low potential for adsorption to sediments. Exposure of the sediment to toxicologically significant concentrations of the enzyme is thus not expected.
As no soil ecotoxicity data are available for the test enzyme, the PNEC for soil is based on the PNEC for surface water using the equilibrium partitioning method. PNEC soil was estimated to 568 µg active enzyme protein/kg soil dw.
The enzyme is not expected to cause any significant secondary poisoning as it is ready biodegradable and has no bioaccumulation potential. Furthermore, as the test enzyme is a protein it is expected to be degraded in the gastrointestinal tract. Thus, PNEC oral is not relevant.
Conclusion on classification
Based on the available data glutamyl endopeptidase is classified as acute aquatic toxic.
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