Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 835-272-7 | CAS number: 256374-76-2
- 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:
- January 10, 2013 to February 7, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Version / remarks:
- OECD Guidelines for Testing Chemicals, No.301C, July 17, 1992, “Ready Biodegradability: Modified MITI Test (I)”
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Testing Standards
- Version / remarks:
- “Biodegradation study of chemical substances by microorganisms” stipulated in “Order Prescribing the Tests Relating to the New Chemical Substances” (Yaku-shoku-Hatsu No. 0331-7, Heisei 23.03.29 Seikyoku No. 5, Kanpoki-Hatsu No. 110331009, dated March 31, 2011; Yaku-shoku-Hatsu No. 0402-1, Heisei 24.03.28 Seikyoku No. 2, Kanpoki-Hatsu No. 120402001, partially revised on April 2, 2012)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report.
- Oxygen conditions:
- not specified
- Inoculum or test system:
- activated sludge, adapted
- Details on inoculum:
- Activated sludge
In accordance with the test method, sludge were sampled from 10 locations in Japan (surface waters containing surface soils at rivers, lakes, ponds, and inland seas, and return sludge of sewage plants), prepared and controlled as activated sludge in Kurume Laboratory. This activated sludge was used for the test (sampling time: November, 2012; start date of use: December 20, 2012). For the test, the activated sludge was used at approximately 19 hours after addition of synthetic sewage (prepared by dissolving glucose, peptone and potassium dihydrogen phosphate into purified water and adjusting pH to 7.0+/-1.0). - Duration of test (contact time):
- 28 d
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Implementation of test
Preparation of the test
Determination of volume of additive activated sludge
The concentration of the suspended material in the activated sludge was measured in accordance with the following method. By considering this concentration, the amount of the activated sludge, which was added into each test vessel, was determined to be 2.57 mL.
Measurement method: Section 14.1 of JIS K 0102-2008
Date of measurement: January 7, 2013
Result of measurement: 3500 mg/L
Preparation of mineral media
Each 3 mL of solution A, B, C and D, whose compositions are prescribed in section 21, JIS K 0102-2008, was diluted with purified water (Takasugi Pharmaceutical Co., Ltd., Japanese Pharmacopeia grade) to make 1 L respectively in order to prepare total 4 L of mineral media and then the pH of the mineral media was adjusted to 7.0.
Validation of activity of activated sludge
It was confirmed by using aniline that the activated sludge was sufficiently active.
Preparation of the test solution
Test solutions were prepared as the following method for 6 test vessels.
Addition of the test substance and aniline
1) Water + Test substance (1 vessel, as vessel [1])
To give 100 mg/L of the test substance concentration, 300 mL of purified water and 30 mg of the provided test sample were placed in the test vessel. The provided test sample was accurately weighed with an analytical electronic balance.
2) Sludge + Test substance (3 vessels, as vessel [2], [3] and [4])
To give 100 mg/L of the test substance concentration, the mineral medium (amount of 300 mL minus added volume of the activated sludge (2.57 mL)) and 30 mg of the provided test sample were placed in the test vessels. The provided test sample was accurately weighed with an analytical electronic balance.
3) Sludge + Aniline (1 vessel, as vessel [6])
To give 100 mg/L of aniline concentration, the mineral medium (amount of 300 mL minus added volume of the activated sludge (2.57 mL)) and 29.5 μL (30 mg) of aniline were placed in the test vessel. Aniline was dispensed using a micro syringe.
4) Sludge blank (1 vessel, as vessel [5])
The mineral medium (amount of 300 mL minus added volume of the activated sludge (2.57 mL)) was placed in the test vessel.
Inoculation of the activated sludge
The activated sludge was added to each test solution of 2), 3) and 4) to make the concentration of the suspended solid at 30 mg/L.
Apparatus and conditions of cultivation
Apparatus for test solution cultivation
Closed system oxygen consumption measuring apparatus
Thermostatic Bath (including measurement unit): AI-0001 (Asahi Techneion Co.,Ltd.)
Data processor: OM7000A (Ohkura Electric Co., Ltd.)
Test vessel: Glass Culture Bottle
Carbon dioxide absorbent: Soda Lime (for carbon dioxide absorption, Wako Pure Chemical Industries, Ltd.)
Culture conditions
Cultivation temperature: 25 ± 1oC
Cultivating duration: 28 days (protected from light)
Stirring method: Rotary stirring by a magnetic stirrer
Observation
During incubation period, conditions of the test solutions were visually observed every day.
Measurement of Biochemical Oxygen Demand (BOD)
During incubation period, BOD values of the test solutions were continuously measured by the closed system oxygen consumption measuring apparatus. Temperature in the thermostatic bath of the closed system oxygen consumption measuring apparatus was recorded every day.
Analysis of the test solution
After the completion of incubation period, qualitative analysis for the test substance in the test solution was conducted to confirm presence of transformed products. Because the test substance, which was a reaction product containing several components, had a large difference of amount between the main component and the sub components, a quantitative analysis of all the components could not be conducted in the same analytical condition.
Therefore, amounts of the main component and sub components were separately measured.
Concentrations of each component are expressed as a concentration of the test sample without consideration of component composition. Based on the results of the preliminary examination that was conducted before the main test, the test substance was considered not to dissolve into test solution completely. Therefore, analysis of dissolved organic carbon (DOC) was not conducted. pH of the test solution of “Water + Test Substance” and “Sludge + Test substance” was measured.
Pretreatment of test solution
The test solution of “Water + Test Substance”, “Sludge + Test Substance” and “Sludge Blank” were pretreated in accordance with the following scheme for preparing samples for Liquid Chromatography-Mass Spectroscopy (LC-MS) for analysis of the test substance (main component), samples for Liquid Chromatography-Tandem Mass Spectroscopy (LC-MS/MS) for analysis of the test substance (sub components), and samples for LC-MS for qualitative analysis of transformed products.
Calculation method for percentage biodegradation
Percentage biodegradation was calculated based on the following formula and the calculated value was rounded to whole number to display.
Because the test substance, which was a reaction product, had a large difference of content between the main component and the sub components, a quantitative analysis of all the components could not be conducted in the same analytical condition. Therefore, for obtaining biodegradation (for sub components, percentage of decrease amount), the main component and sub components were separately calculated.
For sub components, since percentage of residual amount of the measured substance in “Water + Test Substance” was below 90% (64%), the percentage biodegradation of the measured substance (biodegradation of the measured substance by a direct analysis) was not calculated, but the percentage of decrease amount to the adding quantity of the test substance was calculated instead.
Biodegradation by BOD
Biodegradation (%) = (BOD-B)/TOD x 100
BOD: Biochemical oxygen demand of “Sludge + Test substance” (measured value: mg)
B: Biochemical oxygen demand of “Sludge Blank” (measured value: mg)
TOD: Theoretical oxygen demand which is required when the test substance is completely oxidized (calculated value: mg)
TOD was calculated using the molecular formula of the main component, C12H26N2O6P2, and a form of nitrogen was assumed to be nitrous acid (NO2).
Biodegradation by degradation of specific test substances
Biodegradation of the main component
Biodegradation (%) = (Sw-Ss)/Sw x 100
Ss: Residual amount of the measured substance in “Sludge + Test Substance” (measured value: mg)
Sw: Residual amount of the measured substance in “Water + Test Substance” (measured value: mg)
Percentage of decrease amount of sub components
Percentage of decrease amount (%) = (Sw-Ss)/Sw x 100
Ss: Residual amount of the measured substance in “Sludge + Test Substance” (measured value: mg)
Sw: Added volume of the measured substance (mg) - Reference substance:
- aniline
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- >= 3 - <= 4
- Sampling time:
- 28 d
- Details on results:
- Biodegradation after 28 days is as follows.
Because the test substance, which was a reaction product, had a large difference of content between the main component and the sub components, a quantitative analysis of all the components could not be conducted in the same analytical condition. Therefore, for obtaining biodegradation (for sub components, percentage of decrease amount), the main component and sub components were separately calculated.
For sub components, since percentage of residual amount of the measured substance in “Water + Test Substance” was below 90% (64%), the percentage biodegradation of the measured substance (biodegradation of the measured substance by a direct analysis) was not calculated, but the percentage of decrease amount to the adding quantity of the test substance was calculated instead.
Biodegradability of total test substance
Concentrations of sub components in the provided test sample are unknown. However, based on the proportion of the main component and sub component 1 (half type) (main component: 98.82%, half type: 1.18%, according to information from the sponsor), the main component content was set to be 98.82% and the sub components content (total amount of 6 components) was set to be 1.18%, and these % contents were used for correcting residual amounts and a theoretical value so that a total biodegradability of the test substance was calculated.
As a result, the biodegradation of the test substance (total value) was -5 to -3%, biodegradation by BOD was 3 to 4%, and therefore no biodegradability was noted. Since the test substance contained quaternary carbon structures which were hardly biodegraded and were derived from the reacted raw material into its structural formula, it was considered that the test substance was not biodegraded. - Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Under the condition of this study, most of the test substance was persistent and not biodegradable. Some sub components were transformed and the amounts of transformed products are considered to be small (below 1% of the total of test substance).
- Executive summary:
Test conditions
Test substance concentration: 100 mg/L
Activated sludge concentration: 30 mg/L (as suspended material concentration)
Test solution volume: 300 mL
Incubation temperature for test solution: 25+/-1ºC
Incubation period for test solution: 28 days (protected from light)
Measurement and analysis for calculation of biodegradability (percentage of decrease amount)
a) Measurement of biochemical oxygen demand (BOD) by closed system oxygen consumption measuring apparatus
b) Quantitative analysis of test substance (main component) by liquid chromatography – mass spectrometry (LC-MS)
c) Quantitative analysis of test substance (sub components) by liquid chromatography – tandem mass spectrometry (LC-MS/MS)
Test results
Sludge + test substance
[2]
[3]
[4]
Mean
BOD biodegradation
%
3
4
4
4
Test substance*2
Main component biodegradation
(LC-MS)
%
-3
-5
-5
0 (-4)*1
Sub components percentage of decrease amount*3
(LC-MS)
%
41
48
43
44
*1Since the mean value of biodegradation was calculated as a negative value, it was expressed as “0” and the calculated value was indicated in parentheses.
*2Because the test substance, which was a reaction product, had a large difference of content between the main component and the sub components, a quantitative analysis of all the components could not be conducted in the same analytical condition. Therefore, for obtaining biodegradation (for sub components, percentage of decrease amount), the main component and sub components were separately calculated.
*3Since percentage of residual amount of the measured substance in “Water + Test Substance” was below 90% (64%), the percentage biodegradation of the measured substance (biodegradation of the measured substance by a direct analysis) was not calculated, but the percentage of decrease amount to the adding quantity of the test substance was calculated instead.
Conclusion
Under the condition of this study, most of the test substance was persistent and not biodegradable.
Some sub components were transformed, but the amounts of transformed products are considered to be small (below 1% of the total amount of the test substance).
Reference
Confirmation of test conditions
Standard values for validity of the test and the values obtained from this test are shown in the following table. Since all values of this test met with standard values, this test was validated. A form of nitrogen was assumed to be ammonia for calculation of biodegradation by BOD of aniline.
|
Value in the test |
Standard value |
|
Difference between the highest and lowest values of biodegradation (or percentage of decrease amount) |
Biodegradation by BOD |
1% |
<20% |
Biodegradation of the test substance (ore percentage of decrease amount) |
Main: 2% Sub: 7% |
||
Biodegradation of BOD of aniline |
After 7 days |
74% |
>40% |
After 14 days |
98% |
>65% |
|
BOD of “Sludge Blank” |
After 28 days |
8.2 mg |
<60 mg/L (<18 mg) |
Condition of the test solution
Conditions of the test solutions are shown in the following table:
|
Test solution |
Condition (by visual observation) |
pH |
At the start of incubation |
Water + Test Substance |
The test substance was not dissolved. The test solution was colourless. |
-- |
Sludge + Test Substance |
The test substance was not dissolved. The test solution was colourless. |
-- |
|
At the end of incubation |
Water + Test Substance |
No undissolved substance was observed. The test solution was colourless |
[1] 5.9 |
Sludge + Test Substance |
No undissolved substance except sludge was observed. No growth of sludge was observed. The test solution was colourless. |
[2] 7.0 [3] 7.1 [4] 7.0 |
Analysis result of test solution
The results of analysis after 28 days are shown below
|
Water + Test Substance |
Sludge + Test Substance |
Theoretical Amount |
|||
[1] |
[2] |
[3] |
[4] |
|||
BOD*4 |
mg |
2.4 |
1.6 |
2.3 |
2.0 |
54.0*5 |
Amount and rate of residual test substance (main component) (LC-MS) |
mg |
28.8 |
29.7 |
30.2 |
30.1 |
30.6*6 |
% |
96 |
99 |
101 |
100 |
- |
|
Amount and rate of residual test substance (sub components) (LC-MS/MS)*7 |
mg |
19.1 |
17.6 |
15.5 |
17.0 |
30.0*6 |
% |
64 |
59 |
52 |
57 |
- |
|
Detection of transformed products (LC-MS) |
- |
Not detected |
- |
*4 Values in “Sludge + Test substance” are shown after subtracting the value of Sludge Blank.
*5 Calculated from the molecular formula of the main component of the test substance.
*6 Since concentrations of the main component and sub components are unknown, theoretical value of 30.0 mg was used for calculation.
*7 Calculated using total peak area on chromatogram.
Biodegradation
Biodegradation after 28 days
|
Sludge + Test substance |
|||||
[2] |
[3] |
[4] |
Mean |
|||
Biodegradation by BOD |
% |
3 |
4 |
4 |
4 |
|
Test substance |
Biodegradation of the main component (LC-MS/MS) |
% |
-3 |
-5 |
-5 |
0 (-4)*8 |
Percentage of decrease amount of sub components (LC-MS/MS) |
% |
41 |
48 |
43 |
44 |
*8Since the mean value of biodegradation was calculated as a negative value, it is expressed as “0” and the calculated value was indicated in parentheses.
Biodegradation of total test substance
|
Water + Test Substance |
Sludge + Test Substance |
Theoretical Amount |
|||
[1] |
[2] |
[3] |
[4] |
|||
Residual amount of the main component*9 |
mg (1) |
28.5 |
29.3 |
29.8 |
29.7 |
29.6*10 |
Residual amount of the sub components*11 |
mg (2) |
0.225 |
0.208 |
0.183 |
0.201 |
0.354*12 |
Residual amount and residual rate of the total test substance ((1)+(2)) |
mg |
28.7 |
29.6 |
30.0 |
29.9 |
30.0 |
% |
96 |
99 |
100 |
100 |
-- |
|
Percentage biodegradation of the total test substance |
% |
-- |
-3 |
-5 |
-4 |
-- |
*9Residual amount of the main component (shown in analysis table) x 0.9882 (which is a content rate of the main component).
*10Theoretical amount of the main component (30.0 mg) (shown in analysis table) x 0.9882 (which is a content rate of the main component).
11*Residual amount of sub components (shown in analysis table) x 0.0118 (which is a content rate of the cub components).
*12Theoretical amount of the main component (30.0 mg) (shown in analysis table) x 0.0118 (which is a content rate of the sub components).
Description of key information
Under the condition of this study, most of the test substance was persistent and not biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
- Type of water:
- freshwater
Additional information
Test conditions
Test substance concentration: 100 mg/L
Activated sludge concentration: 30 mg/L (as suspended material concentration)
Test solution volume: 300 mL
Incubation temperature for test solution: 25+/-1ºC
Incubation period for test solution: 28 days (protected from light)
Measurement and analysis for calculation of biodegradability (percentage of decrease amount)
a) Measurement of biochemical oxygen demand (BOD) by closed system oxygen consumption measuring apparatus
b) Quantitative analysis of test substance (main component) by liquid chromatography – mass spectrometry (LC-MS)
c) Quantitative analysis of test substance (sub components) by liquid chromatography – tandem mass spectrometry (LC-MS/MS)
Test results
|
|
Sludge + test substance |
||||
|
[2] |
[3] |
[4] |
Mean |
||
BOD biodegradation |
% |
3 |
4 |
4 |
4 |
|
Test substance*2 |
Main component biodegradation (LC-MS) |
% |
-3 |
-5 |
-5 |
0 (-4)*1 |
Sub components percentage of decrease amount*3 (LC-MS) |
% |
41 |
48 |
43 |
44 |
*1Since the mean value of biodegradation was calculated as a negative value, it was expressed as “0” and the calculated value was indicated in parentheses.
*2Because the test substance, which was a reaction product, had a large difference of content between the main component and the sub components, a quantitative analysis of all the components could not be conducted in the same analytical condition. Therefore, for obtaining biodegradation (for sub components, percentage of decrease amount), the main component and sub components were separately calculated.
*3Since percentage of residual amount of the measured substance in “Water + Test Substance” was below 90% (64%), the percentage biodegradation of the measured substance (biodegradation of the measured substance by a direct analysis) was not calculated, but the percentage of decrease amount to the adding quantity of the test substance was calculated instead.
Conclusion
Under the condition of this study, most of the test substance was persistent and not biodegradable.
Some sub components were transformed, but the amounts of transformed products are considered to be small (below 1% of the total amount of the test substance).
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.