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EC number: 700-937-1 | CAS number: 1312021-45-6
- 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:
- August 24th - September 21st, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was performed according to GLP requirements, no critical deviations from the study plan were observed
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
- Deviations:
- yes
- Remarks:
- , pH of test water was 7.1 instead of 7.4 +/- 0.2 as mentioned in the study plan
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
- Deviations:
- yes
- Remarks:
- , pH of test wtaer was 7.1 insetad of 7.4 +/- 0.2 as mentioned in the study planwas
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting range: 0,7-10,2 °C 240°C
- Boiling point: substance decomposites at approx. 240°C
- Vapour pressure: 1.84 mPa
- Water solubility (under test conditions): 0,12 g/L
- Stability of test material at room temperature: 36 months
- pH dependance on stability: Hydrolysis of substance is to be expected at pH > 7 - 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):
Activated sludge (microorganisms from a domestic wate water treatment plant) was supplied by sewage plant Rossdorf, Germany.
- Storage conditions: Sludge was re- suspened in test water after washing and aerated overnight.
- Storage length: 1 day
- Preparation of inoculum for exposure:
- Pretreatment: The aerobic activated sludge used for this study was washed by centrifugation and the supernatant liquid phase was decanted. The solid material was re-suspended in tap water and centrifuged again. This procedure was done three times. The sediment was re-suspended in test water and aerated overnight.
- Initial cell/biomass concentration: Aliquots of washed sludge corresponding to 4g dry matter per litre wer mixed with test water
- Water filtered: yes
- Type and size of filter used, if any: cotton wool filter - Duration of test (contact time):
- 28 d
- Initial conc.:
- 3.04 mg/L
- Based on:
- ThOD/L
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium:
Reconstituted Water:
In deionised water analytical grade salts were added to
prepare the following stock solutions:
a) 8.5 g KH2PO4, 21.75 g K2HPO4, 33.4 g Na2HPO4 x 2
H2O, 0.5 g NH4Cl filled up with deionised water to
1000 mL volume
b) 22.5 g MgSO4 x 7H2O filled up with deionised water to
1000 mL volume
c) 36.4 g CaCl2 x 2H2O filled up with deionised water to
1000 mL volume
d) 0.25 g FeCl3 x 6H2O filled up with deionised water to
1000 mL volume
In order to avoid precipitation of iron hydroxide in the stock solution d) immediately before use, one drop of concentrated HCl per litre was added.1 mL of the stock solutions a) - d) were combined and filled to a final volume of 1000 mL with deionised water. The test medium was aerated for 20 minutes and allowed
to stand for about 20 hours at the test temperature. The dissolved oxygen concentration was 8.4 – 8.5 mg/L at about 20.0 – 21.4 C.
- Test temperature: 21.6-22.3°C
- pH: 7.1 (at the start of the test)
- pH adjusted: no, but 1 drop HCl was added to the stock solution to avoid precipitation of iron hydroxide
- CEC (meq/100 g):
- Aeration of dilution water: yes, aeration was performed for 20 min. to yield a concentration of dissolved oxygen of 8.4-8.5 mg/L
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: Karlsruher flasks 268 ml volume with glass stoppers
- Number of culture flasks/concentration: 16 bottles containing the test item and inoculum, 16 bottles containing the reference item sodium benzoate and inoculum (procedure control), 16 bottles containing only inoculum (inoculum control), 10 bottles containing the test item, sodium benzoate and inoculum (toxicity control)
- Method used to create aerobic conditions: The test solution was aerated before used in the test. The oxygen concentration was 8.4 - 8.5 mg/l.
- Measuring equipment: The oxygen concentrations were electrochemically measured in an airtight system with an O2 - electrode (WTW Oxi 340, Wissenschaftlich Technische Werkstätten GmbH, Weilheim, germany) under constant stirring.
- Test performed in closed vessels due to method given by OECD 301 D
SAMPLING
- Sampling frequency: Oxygen measurements were performed in duplicate on days 0,3,5,7,12,14,21 and 28.
(Measurments of toxicity controls were done only on days 0,7,14,21 and 28)
- Sampling method:
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2.5 ml of filtered inoculum were diluted in 5 L of aqueous test medium
- Toxicity control: 14.9 mg of test item and 20.3 mg of sodium benzoate (THOD 14.44 mg/L O2) were thouroghly mixed into 5 L of aqueous medium. Then 2.5 ml of filtered inoculum was added
- Procedure control: 4.06 mg/L sodium benzoate (THOD 1.666 mg/L O2) were diluted in 5 L of aqueous medium. 2.5 ml of filtered inoculum was added.
- Test item: 15.2 mg of dermosoft decalact (THOD 2.577 mg/L) were diluted in 5 L of aqueous medium. Then 2.5 ml of filtered inoculum was added.
STATISTICAL METHODS:
Oxygen measurements were performed in duplicate. Mean values were calculated. - Reference substance:
- benzoic acid, sodium salt
- Remarks:
- Purity: 100.4%
- Preliminary study:
- not applicable
- Parameter:
- % degradation (O2 consumption)
- Value:
- 66
- St. dev.:
- 0
- Sampling time:
- 28 d
- Details on results:
- Biodegr adation of Test Item
Percentage Biodegradation: Under the test conditions the percentage biodegradation of
Dermosoft® decalact reached in the mean 42 % after
3 days of incubation and continuously increased to 64 %
after 12 days and 66% after 28 days. The results are represented
in Tables 1 - 3 and Figure 1.
Conclusion: The percentage biodegradation exceeded 60 % within the
10-day window. - Parameter:
- BOD5
- Value:
- 5.2 other: mg/L
- Results with reference substance:
- Degradation of sodium benzoate reached 71% after 3 days and was 98% at day 28.
O2 depletion was 6.6 (mg/L) after 28 days of exposure - Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The percentage biodegradation exceeded 60 % within the 10-day window. The test item can therefore be considered as ready biodegradable.
- Executive summary:
Ready Biodegradability of Dermosoft® decalact in a Closed Bottle Test following the methods laid down in:
Commission Regulation 440/2008/Ec Method C.4 -E (Closed Bottle Test) and OECD Guideline No. 301 D: "Ready Biodegradability: Closed Bottle Test", adopted July 17, 1992
The purpose of this study was to determine the ready biodegradability of the test item Dermosoft® decalact. The test item was exposed to activated sludge from the aeration tank of a domestic waste water treatment plant for 28 days. The biodegradation was followed by the oxygen uptake of the microorganisms during exposure. As a reference item sodium benzoate was tested simultaneously under the same conditions as the test item, and functioned as a procedure control. A Closed Bottle Test was chosen for the determination of the ready biodegradability since the test item is well soluble in test water at the recommended test concentration.
Under the test conditions the percentage biodegradation of Dermosoft® decalact reached in the mean 42 % after 3 days of incubation and continuously increased to 64 % after 12 days and 66% after 28 days. The results are represented in Tables 1 - 3 and Figure 1. Conclusion: The percentage biodegradation exceeded 60 % within the 10-day window. The validation criteria are fulfilled. Oxygen Concentration: The residual oxygen concentration in the test flasks did not drop below 2.4 mg O2/L at any time. According to the test guideline, the residual oxygen concentration in the test flasks should not drop below 0.5 mg O2/L at any time except the analytical method is capable to detect these amounts. The oxygen concentration dropped below 0.5 mg/L in the toxicity control due to the complete biodegradation of sodium benzoate. The oxygen measurement equipment used is able to detect an amount of 0.1 mg/L oxygen in aqueous solutions. Test Item: The difference of duplicate values for the degradation of Final Report (2nd Original) IBACON Project 76951161 - Ready Biodegradability of Dermosoft® decalact in a Closed Bottle Test page 18 of 23 the test item at the plateau, at the end of the test and at the end of the 10-day window was less than 20 %. Reference Item (Sodium Benzoate): The percentage degradation of the reference item sodium benzoate should reach the level for ready biodegradability (> 60 %) by exposure The test item can therefore be considered as ready biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Sep - 09 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was performed according to GLP requirements. Deviations were reported but assesed as non-critical by the study director.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Deviations:
- yes
- Remarks:
- , but the deviations from study plan were assessed to be uncritical for the outcome of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)
- Deviations:
- yes
- Remarks:
- , but the deviations from study plan were assessed to be uncritical for the outcome of the study
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz, Mainz, Germany
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge:
The sludge was taken from a biologic sewage treatment plant which is treating mostly domestic sewage. Sludge was taken on Sep 7th, 2012, from the activation basin of ESN (Stadtentsorgung Neustadt) sewage treatment plant, located in Altenschemel, NW-Lachen - Speyerdorf in Germany.
- Pretreatment: The sludge was filtrated, washed with tap water twice, then washed with resuspended test medium. Then aerated for ≥ 12 hours.
- Concentration of sludge: 25,0 mg dry matter/L, determined by 4120 mg suspended sludge/L. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 35.1 mg/L
- Based on:
- test mat.
- Initial conc.:
- 20 mg/L
- Based on:
- other: nominal organic carbon content
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium: according to guideline
- Test temperature: 20.5 - 23.0 °C
- pH: 6.94 - 7.62
- pH adjusted: no
- Inoculum concentration: 25 mg/L
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: 2000 mL glass flasks
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: The test vessels were aerated with purified (by activated charcoal), CO2-scrubbed, moistened air. The scrubbing of carbon dioxide was achieved by bubbling the purified air through a flask containing 1.5 m-NaOH. To control the absence of CO2, the air was then led through a flask containing a solution of Ba(OH)2 before reaching the test vessels.
- Details of trap for CO2 and volatile organics if used: flask containing a solution of Ba(OH)2
SAMPLING
- Sampling frequency: Sampling was done on days 0, 2, 4, 7, 9, 11, 14, 18, 22 and 29
- Sampling method: 10 samples of 1 mL each were taken from each front scrubber flask. On day 29, samples from both flasks were taken.
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes, 2 flasks, containing mineral medium and inoculum
- Abiotic sterile control: yes, 1 flask, containing test item, mineral medium and HgCl2
- Toxicity control: yes, 1 flask, containing test item, positive control, mineral medium and inoculum
- Positive control: yes, 2 flasks, containing positive control, mineral medium and inoculum - Reference substance:
- aniline
- Remarks:
- Phenylamine C6H5NH2, CAS 62-53-3
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 75
- Sampling time:
- 28 d
- Remarks on result:
- other: mean of two replicates
- Details on results:
- The following data were determined for the test item dermosoft® decalact:
10-day-window: day 2 – 12
degradation at the end of 10-day-window 64 %
degradation flask 1: 73.7% after 28 d
degradation flask 2: 75.8% after 28 d
degradation at the end of the test 75 %
pass level following guideline: 60% at the end of 10-day-window - Results with reference substance:
- Aniline was chosen as positive control.
Activated sludge was used as inoculum (concentration in the test 25.0 mg dry matter/L). The test was left running for 28 days.
All validity criteria were met. Degradation of the positive control was 63 % after fourteen days. - Validity criteria fulfilled:
- yes
- Remarks:
- Please refer to Table 1 at "Any other information on results incl. tables"
- Interpretation of results:
- readily biodegradable
- Conclusions:
- • The test item dermosoft® decalact is considered as “readily biodegradable“.
• The degree of biodegradation reached 75 % after 28 days.
• The 10-day-window began on day 2, at its end, 64 % were reached, surpassing the pass level of 60 % given in the OECD guideline. - Executive summary:
The test item dermosoft® decalact was tested using a concentration of nominally 20 mg organic carbon/L (corresponding to 35.1 mg dermosoft® decalact/L) in test medium following OECD 301B and EU-Method C.4-C.
Aniline was chosen as positive control.
Activated sludge was used as inoculum (concentration in the test 25.0 mg dry matter/L). The test was left running for 28 days.
All validity criteria were met. Degradation of the positive control was 63 % after fourteen days.
The following data were determined for the test item dermosoft® decalact:
10-day-window: day 2 – 12
degradation at the end of 10-day-window 64 %
degradation at the end of the test 75 %
pass level following guideline: 60% at the end of 10-day-windowTherefore, when applying the 10-day-window, dermosoft® decalact is readily biodegradable following OECD 301B/EU C.4-C.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 24 Aug - 21 Sep 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- adopted July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Version / remarks:
- May 30, 2008
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Aerobic activated sludge (microorganisms from a domestic wastewater treatment plant) was supplied by the sewage works of Darmstadt, Germany
- Pretreatment: The aerobic activated sludge used for this study was washed by centrifugation and the supernatant liquid phase was decanted. The solid material was re-suspended in tap water and centrifuged again. This procedure was done three times. An
aliquot of the final sludge suspension was weighed, dried and the ratio of wet sludge to its dry weight was determined.
- Concentration of sludge: 1.5 g dw/L - Duration of test (contact time):
- 28 d
- Initial conc.:
- 33 mg/L
- Based on:
- test mat.
- Initial conc.:
- 84 mg/L
- Based on:
- ThOD
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Test temperature: 22°C
- pH: 6.7 – 7.5
- pH adjusted: no
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: BSB Sensomat system, Aqualytic Dortmund
- Measuring equipment: The consumption of oxygen was determined by measuring the change of pressure in the flasks.
- Details of trap for CO2 and volatile organics if used: Potassium hydroxide solution (45%)
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2
- Abiotic sterile control: 1
- Toxicity control: 1 - Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (O2 consumption)
- Value:
- 63
- Sampling time:
- 28 d
- Results with reference substance:
- The reference item sodium benzoate was sufficiently degraded to 84% after 14 days and to 97% after 28 days of incubation.
- Validity criteria fulfilled:
- yes
- Remarks:
- Please refer to "Any other information on results incl. tables"
- Interpretation of results:
- readily biodegradable, but failing 10-day window
Referenceopen allclose all
Validity Criteria of the Study
Inoculum Control: Oxygen depletion in the inoculum control did not exceed 1.5 mg O2/L after 28 days.
Oxygen Concentration: The residual oxygen concentration in the test flasks did not drop below 2.4 mg O2/L at any time. According to the test guideline, the residual oxygen concentration in the test flasks should not drop below 0.5 mg O2/L at any time except the analytical method is capable to detect these amounts. The oxygen concentration dropped below 0.5 mg/L in the toxicity control due to the complete biodegradation of sodium benzoate. The oxygen measurement equipment used is able to detect an amount of 0.1 mg/L oxygen in aqueous solutions.
Test Item: The difference of duplicate values for the degradation of Final Report (2nd Original) IBACON Project 76951161 - Ready Biodegradability of Dermosoft® decalact in a Closed Bottle Test page 18 of 23 the test item at the plateau, at the end of the test and at the end of the 10-day window was less than 20 %.
Reference Item (Sodium Benzoate): The percentage degradation of the reference item sodium benzoate should reach the level for ready biodegradability (> 60 %) by exposure day 14. The degradation was 71 % after 3 days.
Table 1: Validity criteria for OECD 301B.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
Difference of extremes of replicate values of the removal of the test chemical at the plateau, at the end of the test or at the end of the 10-d window, as appropriate, is less than 20%. |
2.1% |
yes |
Percentage degradation of the reference compound reached the pass level by day 14 (≥ 60%). |
14 day |
yes |
The toxicity control should degrade to at least 35% (based on DOC) or at least 25% (based on ThOD or ThCO2) within 14 d. |
74% |
yes |
The IC content of the test substance suspension in the mineral medium at the beginning of the test must be less than 5% of the TC. |
<1% |
yes |
The total CO2 evolution in the inoculum blank at the end of the test should not normally exceed 40 mg/L medium. |
9.7 mg/L |
yes |
In the toxicity control containing both, the test item and the reference item sodium benzoate, 66% biodegradation was noted within 14 days and 71% biodegradation after 28 days of incubation. Thus, the test item can be assumed to be not
inhibitory to the aerobic activated sludge microorganisms.
The 10-day windows began one day after application, the mean value was calculated to be 24% biodegradation. Therefore, the end of the 10-day window was day 11. After correction for the mean biochemical oxygen demand of the
inoculum controls the mean biodegradation percentage based on ThODNH4 at the end of the 10-day window was 48%, the 10-day window was not passed.
Table 1: Validity criteria for OECD 301F.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
Difference of extremes of replicate values of the removal of the test chemical at the plateau, at the end of the test or at the end of the 10-d window, as appropriate, is less than 20%. |
<20% |
yes |
Percentage degradation of the reference compound reached the pass level by day 14 (≥ 60%). |
>60% after 5 days |
yes |
The toxicity control should degrade to at least 35% (based on DOC) or at least 25% (based on ThOD or ThCO2) within 14 d. |
66% after 14 days |
yes |
The oxygen uptake of the inoculum blank is normally 20-30 mg O2/L and should not be greater than 60 mg/L in 28 days. |
20 mg/L |
yes |
Description of key information
Readily biodegradable (75% after 28 d, OECD 301 B)
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
Three GLP studies on biodegradability following different OECD guidelines are available for Fatty acids, C10-12, esters with polylactic acid, sodium salts. In a key study following OECD guideline 301B, the biodegradation rate was determined by measuring the CO2 evolution. The determined degradation rate was 75% after 28 days. The ten-day window criterion was met. In a second key study, conducted according to OECD guideline 301D, the degradation rate was determined by measuring the O2 consumption of the inoculum. The determined degradation rate after 28 days was 66%; the ten-day window criterion was met.
In a supporting the study, the oxygen consumption of the inoculum was measured in a manometric respirometry test according to OECD 301F. A degradation rate of 63% was determined after 28 days, but the ten-day window criterion was not met.
Based on the available key study results, the substance is considered to be readily biodegradable according to OECD criteria.
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