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Diss Factsheets
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EC number: - | CAS number: -
- 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
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 February - 22 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- TEST MATERIAL
: Harpin-ab Fermentation Extract
- Lot No. of test material: R134-2
- Expiration date of the lot: July 2018
- Storage: -70°C, protected from light
- Active ingredient: 0.4% Harpin-ab proteins - Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge : Aerobic sludge from the mixed treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage situated at San Rocco, Monza (MB), Italia.
- Preparation of inoculum for exposure: The sludge samples were centrifuged, washed and analyzed to quantify the suspended solids concentration for the inoculum preparation.
- Concentration of sludge: 4 mg/L suspended solids - Duration of test (contact time):
- 28 d
- Initial conc.:
- 25.67 mg/L
- Based on:
- TOC
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium: The media were prepared as recommended in the guideline.
- Test temperature: 20°C
- pH: Not specified
- Aeration of dilution water: Not specified
- Suspended solids concentration: The sample has been used with the measured initial concentration of 25.67 mg/L of organic carbon (TOC).
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: Glass bottles with hermetic seal
- Number of culture flasks/concentration: 17 flasks were used (3 replicates checked once a week; 5 replicates checked on day 28)
- Method used to create aerobic conditions: Not specified
- Measuring equipment: Determination of total inorganic carbon was performed using an automatic TOC analyser.
- Test performed in open system: No
- Details of trap for CO2 and volatile organics if used: Not specified
SAMPLING
- Sampling frequency: The concentration of inorganic carbon (TIC) was measured weekly.
- Sampling method: At least 12 hours before every determination of inorganic carbon (TIC) the reaction in one bottle of blank, one of reference substance and one of the test item was stopped with the addition of 6 mL of sodium hydroxide (1 M).
CONTROL AND BLANK SYSTEM
- Inoculum blank: Water containing the culture medium and the inoculum of the sludge; 3 replicates checked once per week; 5 replicates checked on day 28
- Abiotic sterile control: Test item and 50 mg/L HgCl2; 3 replicates checked on the first day; 5 replicates checked on day 28
- Toxicity control: No
- Reference substance:
- benzoic acid, sodium salt
- Remarks:
- A nominal concentration of 24.17 mg/L of organic carbon (TOC) was used
- Key result
- Parameter:
- % degradation (TOC removal)
- Value:
- 88
- Sampling time:
- 28 d
- Results with reference substance:
- The percentage of average degradation of the reference substance was 83% after 28 days of incubation.
The trend of the inorganic carbon and related biodegradation percentages in the bottle containing both the test sample and the reference substance confirm the absence of inhibitory effect of the test sample on the inoculum. - Validity criteria fulfilled:
- yes
- Remarks:
- The mean amount of TIC present in the blank controls at the end of the test is <3 mg C/l and the percentage of average degradation of the reference substance is more than 60% after 14 days of incubation.
- Interpretation of results:
- readily biodegradable
- Conclusions:
- On the basis of results obtained, the test item “Harpin-ab Fermentation Extract” should be considered readily biodegradable under aerobic conditions.
Reference
Abiotic degradation did not occur because the amount of TIC during the test in the abiotic bottles was lower than 10%.
Table 1: Biodegradation results
Check point (Days) |
% biodegradation Reference substance |
% biodegradation Test item |
% biodegradation Reference substance + Test item |
0 |
0 |
0 |
0 |
1 |
8 |
31 |
41 |
7 |
69 |
78 |
- |
14 |
88 |
93 |
- |
21 |
84 |
90 |
- |
28 |
83 |
88 |
83 |
Description of key information
A ready biodegradation study was performed in accordance with OECD Guideline 310. The test item “Harpin-ab Fermentation Extract” was considered readily biodegradable under aerobic conditions.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
- Type of water:
- freshwater
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.
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