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EC number: 680-378-7 | CAS number: 138624-11-0
- 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:
- 2017-03-28 to 2017-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid hydrate
- EC Number:
- 680-378-7
- Cas Number:
- 138624-11-0
- Molecular formula:
- C4H15NO8P2
- IUPAC Name:
- (4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid hydrate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 610-GTH
- Expiration date of the lot/batch: 2019-03-31
- Purity test date: 2017-03-30
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light
- Solubility and stability of the test substance in the solvent/vehicle: 8.1 g/L in water
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Since Alendronic acid monohydrate, CAS # 138624-11-0 was easily soluble in water, the test
media were prepared using a stock solution of 1 g/L in Milli-RO water (tap water purified by
reverse osmosis; Millipore Corp., Bedford, Mass., USA). A weighed amount of 499.61 mg of
Alendronic acid monohydrate, CAS # 138624-11-0 was dissolved in Milli-RO water and
made up to 500 mL. After stirring for 3.5 hours, the final stock solution was clear and
colourless. The pH of the stock solution was 2.6. Aliquots of 133 mL of the stock solution
were added to the test item bottles A and B and to the toxicity control. These test bottles
contained medium with microbial organisms (final volume: 2 litres). The test solutions were
continuously stirred during the test, to ensure optimal contact between the test item and the
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Freshly obtained from a municipal sewage treatment plant: 'Waterschap Aa en Maas', 's-Hertogenbosch, The Netherlands, receiving predominantly domestic sewage.
- Storage length: The inoclum was used immediately.
- Preparation of inoculum for exposure: Before use, the sludge was allowed to settle (31 minutes) and the supernatant liquid was used as inoculum at the amount of 10 mL/L of mineral medium.
- Concentration of sludge: 3.6 g/L of suspended solids
- Initial cell/biomass concentration: 10 ml/L of mineral medium
- Water filtered: yes
- Filter: Acitvated carbon - Duration of test (contact time):
- ca. 28 d
Initial test substance concentration
- Initial conc.:
- ca. 1 g/L
- Based on:
- formulation
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium:
A)8.50 g KH2PO4; 21.75 g K2HPO4; 67.20 g Na2HPO4.12H2O; 0.50 g NH4Cl dissolved in Milli-RO water and made up to 1 litre, pH 7.4 ± 0.2
B)22.50 g MgSO4.7H2O dissolved in Milli-RO water and made up to 1 litre.
C)36.40 g CaCl2.2H2O dissolved in Milli-RO water and made up to 1 litre.
D)0.25 g FeCl3.6H2O dissolved in Milli-RO water and made up to 1 litre.
1 litre mineral medium contains: 10 mL of solution (A), 1 mL of solutions (B) to (D) and Milli-RO water.
- Test temperature: 22.2 to 23.7 oC
- pH: 7.4 ± 0.2
- pH adjusted: no
- CEC (meq/100 g):
- Suspended solids concentration: 3.6 g/L
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: A flask containing the inoculum and test item coupled to 3 CO2 absorbers on the exit air line of the flask. No light was allowed.
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: Aeration at 30-100 mL/mion with sythetic air (80% N2 20% O2)
- Measuring equipment: See detail of trap for CO2
- Test performed in open system: Yes
- Details of trap for CO2: Three CO2-absorbers (bottles filled with 100 mL 0.0125 M Ba(OH)2) were connected in series to the exit air line of each test bottle.
SAMPLING
- Sampling frequency: Titrations were made every second or third day during the first 10 days, and thereafter at least every fifth day until day 28, for the inoculum blank and test suspension. Titrations for the positive and toxicity control were made over a period of at least 14 days.
- Sampling method: Each time the CO2-absorber nearest to the test bottle was removed for titration; each of the remaining two absorbers
was moved one position in the direction of the test bottle. A new CO2-absorber was placed at the far end of the series.
- Sample storage before analysis: Stored overnight and aerated
CONTROL AND BLANK SYSTEM
- Inoculum blank:
- Toxicity control:
STATISTICAL METHODS:
Reference substance
- Reference substance:
- acetic acid, sodium salt
Results and discussion
- Preliminary study:
- No preliminary study was conducted.
% Degradationopen allclose all
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Positive Control
- Value:
- ca. 0
- Sampling time:
- 1 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Positive Control
- Value:
- ca. 22
- Sampling time:
- 4 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Positive Control
- Value:
- ca. 42
- Sampling time:
- 6 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Positive Control
- Value:
- ca. 58
- Sampling time:
- 8 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Positive Control
- Value:
- ca. 71
- Sampling time:
- 11 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Positive Control
- Value:
- ca. 85
- Sampling time:
- 15 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 0
- Sampling time:
- 1 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 0
- Sampling time:
- 4 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 1
- Sampling time:
- 6 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 2
- Sampling time:
- 8 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 2
- Sampling time:
- 11 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 3
- Sampling time:
- 15 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 3
- Sampling time:
- 19 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 3
- Sampling time:
- 22 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 6
- Sampling time:
- 25 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 7
- Sampling time:
- 29 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 1
- Sampling time:
- 1 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 1
- Sampling time:
- 4 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 1
- Sampling time:
- 8 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 1
- Sampling time:
- 11 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 1
- Sampling time:
- 15 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 1
- Sampling time:
- 19 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 2
- Sampling time:
- 22 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 3
- Sampling time:
- 25 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- ca. 6
- Sampling time:
- 29 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Toxicity Control
- Value:
- ca. 0
- Sampling time:
- 1 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Toxicity Control
- Value:
- ca. 16
- Sampling time:
- 4 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Toxicity Control
- Value:
- ca. 22
- Sampling time:
- 6 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Toxicity Control
- Value:
- ca. 26
- Sampling time:
- 8 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Toxicity Control
- Value:
- ca. 30
- Sampling time:
- 11 d
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Remarks:
- Toxicity Control
- Value:
- ca. 37
- Sampling time:
- 15 d
- Details on results:
- On day 29 of the groups that reached that far, all 3 CO2 collecting bottles were collected and analyzed to determine the amount of CO2 produced. For those bottles which only were tested until day 15, the same procedure was done on that day.
BOD5 / COD results
- Results with reference substance:
- The reference subststance showed a normal biodegredation curve.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Alendronic acid monohydrate, CAS # 138624-11-0 was not readily biodegradable under the conditions of the modified Sturm test presently performed.
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