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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:
- 21 Feb - 21 Mar 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances
- Version / remarks:
- N° 0331-7, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare; March 29, 2011, N° 5, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry; n° 110331009, Environmental Policy Bureau, Ministry of the Environment, Japan
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- according to Japanese "Standard Concerning Testing Facility Relating to New Chemical Substances", which can be considered equivalent to European standards.
Test material
Constituent 1
- Specific details on test material used for the study:
- - water solubility: > 50 mg/mL
- stability: stable for a year at room temperature
- storage conditions: at room temperature
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge: standard activated sludge (4223 mg/L) purchased from Chemicals Evaluation and Research Institute, Japan, on 11 Jan 2013
- Method of cultivation: 25 ± 2 °C, at least 5 mg/L dissolved oxygen, pH 7.0 ± 1.0
- Preparation of inoculum for exposure: not specified
- Concentration of sludge: 30 mg/L - 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:
- measured continuously
- Parameter followed for biodegradation estimation:
- DOC removal
- Parameter followed for biodegradation estimation:
- test mat. analysis
- Parameter followed for biodegradation estimation:
- other: analysis of predicted degradation products
- Details on study design:
- TEST CONDITIONS
- Test temperature: 25 °C
- pH: 7.47 - 8.15
- pH adjusted: no
- Continuous darkness: not specified
TEST SYSTEM
- Culturing apparatus: not specified
- Number of culture flasks/concentration: 3
- Method used to create aerobic conditions: not specified
- Measuring equipment: Coulometer: Type OM-2001A, Ohkura Electric Co., Ltd.; Data sampler: DS-3, Asahi Techneion Co., Ltd.
- Test performed in closed vessels due to significant volatility of test substance: not specified, no significant volatility
- Test performed in open system: not specified
SAMPLING
- Sampling frequency: Oxygen consumption: continuous; Temperature, Solubility, Color and Sludge proliferation: daily; pH: at the end of exposure; Total dissolved organic carbon: at the end of exposure
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes, one bottle
- Abiotic sterile control: yes, one bottle
- Reference substance: yes, one bottle
- Toxicity control: no
STATISTICAL METHODS:
- least square method: calculation of regression equation and regression coefficient for calibration curves for LC analysis
- mean values were calculated by the arithmetic mean
Reference substance
- Reference substance:
- aniline
Results and discussion
% Degradationopen allclose all
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 0
- Sampling time:
- 28 d
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 24
- Sampling time:
- 28 d
BOD5 / COD results
- Results with reference substance:
- The degradation rate of the activity control substance aniline was higher than 40 % after 7 d exposure and higher than 65 % after 14 d exposure.
Any other information on results incl. tables
Table 1: Average degradation rate from BOD and from direct determination (LC analysis) of the test substance and main degradation substance.
|
N° |
Test solutions |
Degradation rate (%) |
Average degradation rate |
Degradation rate from BOD |
3 |
Test suspension |
0 |
0 |
4 |
Test suspension |
1 |
||
5 |
Test suspension |
- 1 |
||
Degradation rate of the test substance from direct determination ( LC ) |
3 |
Test suspension |
24 |
24 |
4 |
Test suspension |
25 |
||
5 |
Test suspension |
24 |
||
Degradation rate of the main impurity of the test substance from direct determination ( LC ) |
3 |
Test suspension |
0*11 |
0*11
|
4 |
Test suspension |
0*11 |
||
5 |
Test suspension |
0*11 |
*11 From results of LC analysis of the main impurity of the test substance, its amount in test solutions after the exposure was larger than that added at the beginning. The main impurity of the test substance was estimated to be produced by the transformation of the test substance. Therefore, the amount of the main impurity at the beginning was assumed to fully remain during the exposure time (residual amount = amount added at the beginning), the degradation rate from LC analysis of the main impurity was calculated by using this assumed residual amount.
Table 2. Residual rates (%), production rates (%) and material balance of test substance, main impurity and main degradation products of the test substance.
N° |
Test solutions |
Residual rate (%) |
Production rate (%) |
||||||||
Test substance |
Av. |
Main impurity |
Av. |
Main impurity |
Av. |
degradation product 1 |
Av. |
degradation product 2 |
Av. |
||
3 |
Test suspension |
73 |
73 |
100 |
100 |
8 |
|
0 |
|
0 |
0 |
4 |
Test suspension |
73 |
100 |
8 |
0 |
0 |
|||||
5 |
Test suspension |
74 |
100 |
8 |
0 |
0 |
|||||
6 |
Abiotic control |
97 |
100 |
|
0 |
1 |
N° |
Test solutions |
Production rate (%) |
Material balance – 1 (%) |
Material balance – 2 (%) |
||||||||
|
|
Degr. product 3 |
Av. |
Degr. product 4 |
Av. |
Degr. product 5 |
Av. |
|
Av. |
|
Av. |
|
3 |
Test suspension |
2 |
2 |
3 |
3 |
2 |
2 |
86 |
86 |
94 |
92 |
|
4 |
Test suspension |
2 |
3 |
2 |
85 |
90 |
||||||
5 |
Test suspension |
2 |
3 |
2 |
86 |
93 |
||||||
6 |
Abiotic control |
0 |
0 |
0 |
98 |
- |
||||||
Note:
N°: Channel number of detection unit of coulometer
Production rate: (Production amount of each degradation product) / (Its theoretical [maximum] production amount by the degradation of test substance amount added at the beginning) x 100
Material balance-1: (The summation of residual amount [test substance and main impurity] and production amount*14[main impurity, degradation product 1, degradation product 2, degradation product 3, degradation product 4, and degradation product 5]) / (Test substance [test substance and main impurity] amount added at the beginning) x 100
Material balance-2: (The summation of the above residual and production*14amount and that of mineralized
degradation product 2 equivalent to DOC degradation rate of 5%) / (Test substance amount added at the beginning) x 100
*12 Theoretical [maximum] production amount of degradation products 1 and 2 was calculated on the assumption that they were derived from the hydrolysis of only the test substance, although they were considered to be produced from both the test substance andthe impurity of the test subtance.
*13 Since the degradation products 3, 4 and 5 were difficult to obtain as the analytical standards, the test substance was used as the analytical standard for quantitative analysis of these products on the assumption that each weight adsorption coefficient should be equal to that of the test substance.
*14 Because the production of the degradation product 1 and 2 by hydrolysis results in the addition of water molecule, the material balance will be overestimated by using the values (not corrected) of production amount of degradation products 1 and 2. Therefore, in order to avoid the overestimation due to the addition by water molecule, the material balance was evaluated with the correction taking it into account.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- under test conditions no biodegradation observed
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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