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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
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2011-07-01 to 2011-08-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: "Method for Testing the Biodegradability of Chemical Substances by Microorganisms" (March 31, 2011, N0.0331-7, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Identifier: C-C10
Description: Blackish blue powder
Lot/batch No.: MB-1
Stability under test conditions: The stability of the test item was confirmed by comparing the IR spectrum of the test item after the completion of the experiment with that before the start of the experiment
Storage condition of test material: The test sample was stored in a dark storage place at room temperature.
Constituent 1
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge: mixture of samples from at least 10 different locations in Japan (surface water, surface soil from rivers, lakes and inland sea, sludge from sewage treatment plants)
- Laboratory culture: as described in guideline
- Method of cultivation: as described in guideline
- Storage conditions: as described in guideline
- Storage length: not reported
- Preparation of inoculum for exposure: synthetic sewage was produced from glucose, peptone and potassium dihydrogenphosphate dissolved in purified water and the pH of the solution was adjusted to 7.0 ± 1; activated sludge was fed with the synthetic sewage and sludge was used 19.5 hours after being fed
- Pretreatment: no pretreatment
- Concentration of sludge: 2820 mg/L suspended solids in final sludge
- Water filtered: no - Duration of test (contact time):
- 28 d
Initial test substance concentration
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
Parameter followed for biodegradation estimationopen allclose all
- Parameter followed for biodegradation estimation:
- O2 consumption
- Remarks:
- : During the cultivation period, the change in BOD of the test solutions was measured by a closed system oxygen consumption measuring apparatus.
- Parameter followed for biodegradation estimation:
- DOC removal
- Remarks:
- : After the end of the cultivation, dissolved organic carbon (DOC) was determined.
- Parameter followed for biodegradation estimation:
- test mat. analysis
- Remarks:
- : After the end of the cultivation, the test item in the test solutions were determined.
- Details on study design:
- TEST CONDITIONS
- Composition of medium: 5 L of basal culture medium was prepared by adding purified water to each 3 mL aliquots of solutions a), b), c) and d) as described in the guideline; a total of 5L culture medium was prepared; test material (at 100 mg/L) or reference material (aniline at 100 mg/L) and sludge (at 30 mg suspended solids/L) was added
- Additional substrate: none
- Solubilising agent (type and concentration if used): not applicable
- Test temperature: 25 ± 1 °C
- pH: water + test item: 6.6 - 7.0, sludge + test item: 6.8 - 7.3
- pH adjusted: pH adjustment of culture medium and activated sludge
- Aeration of dilution water: no aeration during test
- Suspended solids concentration: 30 mg/L
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: glass vessels
- Number of culture flasks/concentration: 3
- Method used to create aerobic conditions: not reported
- Measuring equipment: closed system oxygen consumption measuring apparatus with data sampler OM7000A (Ohkura Electric Co. Ltd), temperature controlled bath
- Test performed in closed vessels: yes
- Test performed in open system: not applicable
- Details of trap for CO2: glass vessel containing soda lime
SAMPLING
- Sampling frequency: The oxygen consumption was measured continuously during the incubation period
- Sampling method: Continuous sampling of oxygen; continuous absorption of CO2 in trap
- Sterility check if applicable: one abiotic control was included
- Sample storage before analysis: not applicable
CONTROL AND BLANK SYSTEM
- Inoculum blank: 1 vessel
- Abiotic sterile control: 1 vessel
- Toxicity control: not performed
Reference substance
- Reference substance:
- aniline
Results and discussion
% Degradationopen allclose all
- Parameter:
- % degradation (O2 consumption)
- Value:
- 4
- Sampling time:
- 28 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 2
- Sampling time:
- 28 d
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 2
- Sampling time:
- 28 d
- Details on results:
- The average percentage biodegradation by BOD, that by DOC and that of the test item wae 4%, 2% and 2%, respectively. In addition, thae was no signiscant change of the test item in peak shape on the HPLC chromatograms. From the above-mentioned results, it was considered that the test item was not biodegraded under the test conditions of this study.
BOD5 / COD results
- Results with reference substance:
- The reference substance aniline showed 58 % degradation after 7 days, 78 % degradation after 14 days, 81% degradation after 21 days and 83% degradation after 28 days (based on BOD).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- under test conditions no biodegradation observed
- Conclusions:
- The substance is not biodegradable under the conditions of a modified MITI test.
- Executive summary:
The ready biodegradability of the test substance C-C10 was studied under GLP in a modified MITI test in accordance with OECD TG 301-C (dated from 1992). Activated sludge was obtained by mixing samples from 10 locations in Japan (samples from surface water, river sediment, lakes and inland sea plus sludge from sewage treatment plants). Inoculum was used in the test 19.5 hours after the unit had been fed.
Culture medium prepared in accordance with the guideline was used. The following test media (all at final volume of 300 mL) were tested:
1) water and test substance (100 mg/L) in one abiotic control;
2) activated sludge (30 mg/L suspended solids) and test substance (100 mg/L) in three testing vessels;
3) activated sludge (30 mg/L suspended solids) and reference substance aniline (100 mg/L) in one positive control;
4) activated sludge (30 mg/L suspended solids) as one inoculum control.
The pH value of the 3 test vessels was between 6.8 and 7.3, that of the abiotic control between 6.6 and 7.0. All test media were stirred and inoculated during a period of 28 days at 25 ± 1 °C in the dark in closed vessels connected to an oxygen consumption measuring apparatus. The biodegradation was monitored by continuously measuring the biological oxygen demand. In addition, the dissolved organic carbon was measured and the concentration of the test material was determined by HPLC at the end of the test.
The test material C-C10 was not biodegradable under the conditions of the test since the percentage of biodegradation after 28 days was only 4% based on BOD, 2% based on DOC and 2% based on HPLC analysis.
The reference substance aniline was degraded by 58% after 7 days and 78% after 14 days showing the suitability of the inoculum.
All validity criteria were fulfilled because the difference between extremes of replicates was less than 20%, the BOD of the control blank after 28 days was less than 60 mg/L and the biodegradation was above the required percentages after 7 and 14 days.
In conclusion, the substance C-C10 is not biodegradable under the conditions of a modified MITI test.
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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