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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:
- 18 April 2008 - 11 June 2008.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted to recognised testing methodology to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Test method relating to the new chemical substances
” (Yakushokuhatsu No. 1121002 on November 21, 2003, Heisei 15.11.17 Seikyoku No. 2, Kanpokihatsu No. 031121002 - Deviations:
- no
- Principles of method if other than guideline:
- The biochemical oxygen demand (BOD) generated by degradation of the test substance under the presence of activated sludge was measured during 28 days by a closed system oxygen consumption measuring apparatus. After the completion of measurement of BOD, dissolved organic carbon (DOC) and residual amount of the test substance were also measured. The degradability was calculated based on these measured values to evaluate biodegradability of the test substance.
Measurement of Biochemical Oxygen Demand (BOD) by a closed system oxygen consumption measuring apparatus (for 28 days)
Measurement of Dissolved Organic Carbon (DOC) by total organic carbon measuring apparatus (at day 28)
Measurement of residual amount of test substance by High-Performance Liquid Chromatography (HPLC) (at day 28) - GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): JKY-214
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other tha n submission substance): Not applicable
- Substance type: Organic
- Physical state: White crystal
- Analytical purity: 99.5% w/w
- Impurities (identity and concentrations): Not specified
- Composition of test material, percentage of components:
- Isomers composition: Not applicable
- Purity test date: Not specified
- Lot/batch No.: RM05-58
- Expiration date of the lot/batch: Not specified
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Stable. After the completion of the study, infrared absorption spectrum of the test substance stored in a desiccator for test material storage. The spectrum obtained was consistent with that measured before the initiation of the study. Therefore it was determined that the test substance was stable during storage
- Storage condition of test material: Room temperature, dark, tightly sealed
- Other: Not specified
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable.
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- MLSS: 3700mg/L
Date of receipt: April 17, 2008
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Chemicals Evaluation and Research Institute, Japan
- Laboratory culture: Not specified
- Method of cultivation: Not specified
- Storage conditions: Not specified
- Storage length: Not specified
- Preparation of inoculum for exposure: Not specified
- Pretreatment: Not specified
- Concentration of sludge: 30 mg/l
- Initial cell/biomass concentration: Not specified
- Water filtered: Not specified
- Type and size of filter used, if any: Not specified - Duration of test (contact time):
- 28 d
Initial test substance concentration
- Initial conc.:
- 30 mg/L
- Based on:
- test mat.
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- other: The biochemical oxygen demand (BOD) generated by degradation of the test substance under the presence of activated sludge was measured during 28 days by a closed system oxygen consumption measuring apparatus. After the completion of measurement of BOD, di
- Details on study design:
- Test method
This study was performed in accordance with “Test method relating to the new chemical substances” (Yakushokuhatsu No. 1121002 on November 21, 2003, Heisei 15.11.17 Seikyoku No. 2, Kanpokihatsu No. 031121002).
The biochemical oxygen demand (BOD) generated by degradation of the test substance under the presence of activated sludge was measured during 28 days by a closed system oxygen consumption measuring apparatus. After the completion of measurement of BOD, dissolved organic carbon (DOC) and residual amount of the test substance were also measured. The degradability was calculated based on these measured values to evaluate biodegradability of the test substance.
Degradability test conditions
Degradability test was performed under the following conditions.
(Standard activated sludge)
1) MLSS: 3700mg/L
2) Source: Chemicals Evaluation and Research Institute, Japan
3) Date of receipt: April 17, 2008
(Conditions)
1) Temperature: 25±1oC
2) Period: 28 days (BOD measurement)
3) Test volume: 300mL
4) Concentration: Test substance and aniline* (control material): 100mg/L
Standard activated sludge: 30mg/L
* Kanto Chemical Co., Inc., special grade reagent, Lot No. 907X1751
(Test system and addition of the test material)
No. 1: Confirmation of degradation activity (aniline + sludge + basal medium)
Basal medium*1 was placed in a cultivation bottle, 29.5µL (30.0mg) of aniline was added with microsyringe and mixed, then sludge was added.
No. 2: Basal respiration of sludge (sludge + basal medium)
Basal medium*1 was placed in a cultivation bottle, then sludge was added.
No. 3, 4, 5: Degradation of test substance-1, 2, 3 (test substance + sludge + basal medium)
Basal medium*1 was placed in a cultivation bottle, the test substance was weighed in a glass-cup for 30.0mg and added, then sludge was added.
No. 6: Stable in water (test substance + purified water)
300mL of purified water*2 was poured into the cultivation bottle, the test substance was weighed in a glass-cup for 30.omg and added.
*1: Added amount of sludge suspension for 2.4mL was deducted from 300mL.
*2: JIS K0557 A4 grade.
Calibration curve
Test substance of 30.0mg was weighed and dissolved in acetone to make constant volume of 100mL. 300mg/L of standard solution was prepared and diluted in acetone. Acetone was used as 0mg/L of standard solution, and 0, 75.0, 150 and 300mg/L of the test substance standard solution was analyzed by HPLC to obtain peak area. Calibration curve was prepared with the concentration on the horizontal axis and peak area on the vertical axis.
The least-squares analysis was used to obtain the correlation coefficient of linear regression. The linearity was good as the correlation coefficient was 1.00 and it was accounted that a straight line would pass through the origin. Therefore the amount of the test substance in test solution was calculated by comparing to peak area that was obtained with standard solution of 300mg/L.
Detection limit
The minimum detectable peak area was established to be 10000 mAbs•sec. Based on the amount of the test substance that corresponded to this, the detection limit of the test substance was determined as 0.1mg.
Recovery test
The test solution of Degradation of test substance (n=2) and Basal respiration of sludge (n=1) was prepared in accordance with the preparation method shown in section 2.1, stirred for 30 minutes in closed-sysmtem oxygen consumption measuring apparatus.
Pre-treatment was held in accordance with the procedures in Measurement of residual amount of the test substance in flow sheet of pre-analysis treatment, the residual amount of the test substance was measured, and recovery rate of the test substance was calculated from the value of Degradation of test substance. As the result of two measurements, the recovery rate were 102 and 103 % respectively. The measurement result of the residual amount of test substance was calculated by correcting with the mean recovery rate of 103%. It was confirmed that the residual amount of the test substance was below detection limit in Basal respiration of sludge.
Evaluation of the test results
Formula to calculate degradability
The formula to calculate degradability from the measured value of BOD, DOC and the residual amount of the test substance are shown below.
1) BOD degradability
Degradability (%) = (BODs – BODb) / ThOD x 100
BODs: Oxygen consumption in Confirmation of degradation activity or Degradation of test substance (mg)
BODb: Oxygen consumption in Basal respiration of sludge (mg)
ThOD: Theoretical oxygen demand of aniline or the test substance (mg)
Calculation of theoretical oxygen demand (ThOD)
Aniline: 90.2mgO2/ 30.0mg
Aniline was assumed to be mineralized as below.
C6H7N + 35/4O2 → 6CO2 + 7/2H2O + NO2
The test substance: 59.5mgO2/ 30.0mg
The test substance was assumed to be mineralized as below.
C31H32O8S2 + 37O2 = 31CO2 + 16H2O + 2SO2
2) DOC degradability
Degradability (%) = [1- (DOCs – DOCb) / DOCc] x 100
DOCs: DOC in Degradation of test substance (mg)
DOCb: DOC in Basal respiration of sludge (mg)
DOCc: DOC in Stable in water (mg)
If the DOC in Stable in water is below 90% of initial theoretical amount, DOC degradability was not calculated.
3) Degradability from the residual amount of the test substance
Degradability (%) = (1- Cs/Cc) x 100
Cs: Residual amount of the test substance in Degradation of test substance (mg)
Cc: Residual amount of the test substance in Stable in water (mg)
Judgement of degradability
The degradability of the test substance is judged comprehensively based on BOD, DOC, measured residual amount of the test substance and calculated degradability.
Validity of the study
The study is considered to be valid when all of the following items are satisfied;
1) BOD degradability of reference substance at day 14 is greater than 60%.
2) The difference of the maximum value and the minimum value of the degradability at day 28 does not exceed 20%.
3) BOD in Basal respiration of sludge at day 28 does not exceed 18mgO2.
Reference substance
- Reference substance:
- aniline
Results and discussion
- Preliminary study:
- None conducted; main study only.
- Test performance:
- The study was judged as valid because the measured results satisfied all the items of the validity of the study.
The study is considered to be valid when all of the following items are satisfied;
1) BOD degradability of reference substance at day 14 is greater than 60%.
2) The difference of the maximum value and the minimum value of the degradability at day 28 does not exceed 20%.
3) BOD in Basal respiration of sludge at day 28 does not exceed 18mgO2.
% Degradation
- Parameter:
- other: The biochemical oxygen demand (BOD) and Dissolved Organic Carbon (DOC) where monitored as an assessment of ready biodegradability.
- Value:
- 0
- Sampling time:
- 28 d
- Details on results:
- Environmental factor which might have affected the reliability of the study results:
There was no factor which is applicable to the captioned.
The observation results of the contents in cultivation bottle after BOD measurement:
The solution was cloudy in Confirmation of degradation activity (No. 1), Degradation of test substance-1, 2 (No. 3, 4) and Stable in water (No. 6), slightly cloudy in Degradation of test substance-3 (No. 5).
Growth of sludge was noted in Confirmation of degradation activity compared to Basal respiration of sludge, no growth was noted in Degradation of test substance.
The result of pH measurement:
After the BOD measurement, pH was 7.2 respectively in Degradation of test substance, 8.4 in Stable in water.
BOD degradability:
BOD at day 28 was -0.3, -0.3, -0.2 mg in Degradation of test substance (the values after correction by BOD of Basal respiration of sludge, in the order of No. 3, 4, 5, the same order hereafter) against theoretical value of 59.5mg, 0.5mg in Stable in water. BOD degradability at day 28 was all calculated to be 0% (the calculated values were -1, -1, 0%).
DOC degradability:
DOC at day 28 was 0.1, 0.0, -0.1 mg in Degradation of test substance (the values after correction by DOC of Basal respiration of sludge) against initial theoretical value of 18.7mg, 0.3mg was detected in Stable in water. The test substance was hardly soluble in water and DOC in Stable in water was below 90% of initial theoretical value. Therefore DOC degradability was not calculated.
Degradability from the residual amount of the test substance:
The test substance was detected for 29.7, 30.1, 29.6mg in Degradation of test substance, 29.7mg in Stable in water against initial amount of 30.0mg. The degradability from the residual amount of the test substance was calculated as 0% respectively (calculated values were 0, -1, 0%).
Validity of results:
The study was judged as valid because the measured results satisfied all the items of the validity of the study.
BOD5 / COD results
- Results with reference substance:
- The reference substance fulfilled the validity requirements of the study.
Any other information on results incl. tables
Results (measured values at day 28)
Measured item |
Degradation of test substance |
Stable in water |
Theoretical value |
||
1 |
2 |
3 |
|||
BOD, mg*1 |
-0.3 |
-0.3 |
-0.2 |
0.5 |
59.5 |
DOC, mg*1 |
0.1 |
0.0 |
-0.1 |
0.3 |
18.7 |
Test substance, mg |
29.7 |
30.1 |
29.6 |
29.7 |
30.0 |
*1 Values of Degradation of test substance is shown after deducting the values of Basal respiration of sludge.
Degradability at day 28
Degradability |
Degradation of test substance |
Average |
||
1 |
2 |
3 |
||
Degradability of BOD, % |
0 (-1)*2 |
0 (-1)*2 |
0 |
0 |
Degradability of DOC, % |
Not calculated because the test substance was hardly soluble in water. |
|||
Degradability of residual amount of test substance, % |
0 |
0 (-1)*2 |
0 |
0 |
*2 Calculated degradability is shown in the parentheses because degradability was calculated to be negative value.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- under test conditions no biodegradation observed
- Conclusions:
- Discussion
It is judged that the test substance was not readily biodegradable and not transformed because degradability of BOD at day 28 and degradability of residual amount of test substance were 0% at average. - Executive summary:
Discussion
It is judged that the test substance was not readily biodegradable and not transformed because degradability of BOD at day 28 and degradability of residual amount of test substance were 0% at average.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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