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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
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP, QSAR calculation, acceptable with restrictions.
- Justification for type of information:
- Episuite and the BIOWIN models are well documented and commonly used QSARs for predicting the biodegradation potential of chemicals. Constituents within LOA streams fall within the applicability domain of these models and they have been recommended by ECHA in the Information Requirement Guidelines.
- Reason / purpose for cross-reference:
- assessment report
- Reason / purpose for cross-reference:
- (Q)SAR model reporting (QMRF)
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- BIOWIN v4.1 in EPISuite 4.1 (2017). The Biodegradation Probability Program (Biowin) estimates the probability for the rapid aerobic biodegradation of an organic chemical in the presence of mixed populations of environmental microorganisms. As recommended in the ECHA guidance R.7b, BIOWIN 2, 3, 5 and 6 were used to predict the ready biodegradability of constituents of the category:
BIOWIN 2 = nonlinear probability model
BIOWIN 3 = expert survey ultimate biodegradation model
BIOWIN 5 = MITI linear model
BIOWIN 6 = MITI nonlinear model
Biodegradability estimates are based upon fragment constants that were developed using multiple linear or non-linear regression analyses, depending on the model. BIOWIN 2 is intended to convey a general indication of biodegradability under aerobic conditions, and not for any particular medium (Howard et al., 1992). BIOWIN 3 yield estimates for the time required to achieve complete ultimate and primary biodegradation in a typical or "evaluative" aquatic environment (Boethling et al., 1994). BIOWIN 5 and 6 are predictive models for assessing a compound’s biodegradability in the Japanese MITI (Ministry of International Trade and Industry) ready biodegradation test; i.e. OECD 301C (Tunkel et al., 2000).
The use of QSAR estimates to predict the biodegradability of hydrocarbons are included in the training sets of the BIOWIN. The databases were created using experimental biodegradation data for compounds found in crude oil and its products, with biodegradation references obtained for each of these compounds, mainly from the BIOLOG and DATALOG files of EFDB, TOXLINE and American Chemical Society Chemical Abstracts as well as literature searches. - GLP compliance:
- no
- Specific details on test material used for the study:
- Not applicable
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- not specified
- Details on inoculum:
- Not applicable
- Based on:
- other: QSAR calculation
- Parameter followed for biodegradation estimation:
- other: QSAR calculation
- Details on study design:
- Not applicable
- Preliminary study:
- Not applicable
- Test performance:
- Not applicable
- Parameter:
- probability of ready biodegradability (QSAR/QSPR)
- Remarks:
- BIOWIN 2
- Value:
- >= 0.42 - <= 1
- Remarks on result:
- other: Result from QSAR prediction. Range based on the measured constituents in the streams.
- Parameter:
- calculated rating of total degradation time (QSAR/QSPR)
- Remarks:
- BIOWIN 3
- Value:
- >= 2.33 - <= 3.54
- Remarks on result:
- other: Result from QSAR prediction.Range based on the measured constituents in the streams.Range based on the measured constituents in the streams. Range based on the measured constituents in the streams. Range based on the measured constituents in the streams.
- Parameter:
- probability of ready biodegradability (QSAR/QSPR)
- Remarks:
- BIOWIN 5
- Value:
- >= 0.191 - <= 0.618
- Remarks on result:
- other: Result from QSAR prediction. Range based on the measured constituents in the streams.
- Parameter:
- probability of ready biodegradability (QSAR/QSPR)
- Remarks:
- BIOWIN 6
- Value:
- >= 0.12 - <= 0.87
- Remarks on result:
- other: Result from QSAR prediction. Range based on the measured constituents in the streams.
- Details on results:
- BIOWIN 2, 5, and 6 Result Classification: A probability greater than or equal to 0.5 indicates “Biodegrades Fast” and a probability less than 0.5 indicates “Does NOT Biodegrade Fast”
BIOWIN 3 Result Classification (primary and ultimate): 5.00 - hours, 4.00 - days, 3.00 - weeks, 2.00 - months, 1.00 - longer. A probability greater than or equal to 2.75 indicates "Biodegrades Fast".
Details of the constituents and how their BIOWIN values relate to their persistence assessment are found in the PBT report attached to Section 13 (see cross-reference), and also in the document attached as background material. - Results with reference substance:
- Not applicable
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- The BIOWIN models predict a high probability of ready biodegradability for a number of constituents of these streams. Out of the 119 constituents of the category, and according to the criteria in the R.7b Information Requirement Guidance from ECHA, the following is concluded:
- BIOWIN 2 predicted 118 constituents biodegrade fast
- BIOWIN 3 predicted 101 constituents biodegrade fast (within weeks)
- BIOWIN 5 predicted 22 constituents biodegrade fast
- BIOWIN 6 predicted 55 constituents biodegrade fast
Details of the constituents and how their BIOWIN values relate to their persistence assessment are found in the PBT report attached to Section 13 (see cross-reference), and also in the document attached as background material. - Executive summary:
The predictions of ready biodegradability of the measured constituents of this category (at equal or above 0.1% w/w) have been predicted using the EPISUITE v4.11 BIOWIN models (2017), which use methodology described by Howard et al. (1992), Boethling et al. (1994) and Tunkel et al. (2000). Of the 119 constituents, and according to the criteria set out in the ECHA R.7b Information Requirements Guidance, 118 (BIOWIN 2), 101 (BIOWIN 3), 22 (BIOWIN 5) and 55 (BIOWIN 6) were predicted to be readily biodegradable based on the different models, with 118 constituents having at least one prediction of a high probability that it will biodegrade fast.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 March 2003 to 6 March 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guidelines study, available as unpublished report, acceptable with restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- inoculum preparation which was performed in general agreement with ASTM D5864
- Deviations:
- yes
- Remarks:
- inoculum preparation which was performed in general agreement with ASTM D5864,
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
not reported - Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, adapted
- Details on inoculum:
- obtained from Clinton Sanitary Wastwater Treatment Plant, Annandale, New Jersey on March 5 2003.
- Duration of test (contact time):
- 41 d
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Low DCPD resin oil evaluated at a mean concentration of 50.13 mg/L; postiive control substance, sodium benzoate evaluated at a concentratio of 49.13 mg/L. Triplicate test systems were used to evaluate the iodegradability of the test and positive control substances at mean concentrations of 50.13 mg/L and 49.13 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. The total suspended solids (TSS) of the activated sludge was determined to be 4.13 g/L. The inoculum was added at a 1% loading volume of sludge supernatant to test medium. The microbial count of the inoculum was 106 CFU/mL. One liter of test medium, which was aerated for 24 hours with carbon dioxide free air, was added to each one liter respirometer flask. The test substance was weighed in an air tight syringe and injected into the test medium. The test system was sealed immediately after addition of the test substance. An aliquot of the positive control stock solution was added to the appropriate test flasks. An unacclimated activated sludge inoculum was used in this study. The inoculum was obtained from the Clinton Sanitary Wastewater Treatment Plant, Annandale, NJ, USA. The treatment plant receives domestic sewage. All test systems were placed on a Coordinated Environmental Services
(CES) automated respirometer which automatically recorded the oxygen uptake in general agreement with the OECD guideline. The 41-day study was conducted at a temperature range of 22 ± 1°C. - Reference substance:
- other: Sodium Benzoate
- Preliminary study:
- not reported
- Test performance:
- not reported
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 6.48
- Sampling time:
- 41 d
- Details on results:
- Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance as calculated using results of an elemental analysis of the test substance.
- Results with reference substance:
- 86.4% over 28 days. By day 14, >60% biodegradation of positive control was observed, which meets the guideline requirement. No deviations from the protocol occurred that affected the integrity of the study data.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The average percent biodegradation of the test substance was determined to be 6.48% on day 41.
- Executive summary:
This is a GLP Compliant study following OECD guidelines and is considered adequate for assessment. The average percent biodegradation of the test substance was determined to be 6.48% on day 41.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 16 April 2003 to 17 April 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guidelines study, available as unpublished report, acceptable with restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Principles of method if other than guideline:
- clarifications and exceptions provided but would not affect result
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: Activated Sludge
- Details on inoculum:
- Acclimated inoculum prepared from study 163094A obtained from Clinton Sanitary Wastwater Treatment Plant, Annandale, New Jersey on March 5 2003.
- Duration of test (contact time):
- 56 d
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Low DCPD resin oil evaluated at a mean concentration of 47.20 mg/L; postiive control substance, sodium benzoate evaluated at a concentratio of 51.49 mg/L.. Triplicate test systems with acclimated inoculum were used to evaluate the biodegradability of the test and positive control substances at mean concentrations of 47.20 mg/L and 51.49 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. Triplicate toxicity control test systems, containing both test and positive control substance, were also run concurrently.Acclimated Inoculum was prepared from solids filtered from 163094A test systems. The inoculum for 163094A test systems was obtained from the Clinton Sanitary Wastewater Treatment Plant, Annandale, NJ, USA which receives domestic sewage. The solids were mixed with 200 mL of fresh test medium and added at a 1% loading volume of solids mixture to test medium. The microbial count of the inoculum was 104 CFU/mL. The test medium was aerated for 24 hours with carbon dioxide free air and one liter added to each one liter respirometer flask.The test substance was weighed in an air tight syringe and injected into the test medium. The test system was sealed immediately after addition of the test substance. An aliquot of the positive control stock solution was added to the appropriate test flasks. All test systems were placed on a Coordinated Environmental Services (CES) automated respirometer which automatically recorded the oxygen
uptake in general agreement with the OECD guideline. The 56 day study was conducted at a temperature range of 22 ± 1°C. - Reference substance:
- other: Sodium Benzoate
- Parameter:
- % degradation (O2 consumption)
- Value:
- 43.87
- Sampling time:
- 56 d
- Details on results:
- The average percent biodegradation of the test substance was determined to be 43.87% by day 56. . The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory.
- Results with reference substance:
- By day 14, >60% biodegradation of the positive control was observed.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The mean biodegradation of the test substance was determined to be 43.87% by day 56. The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory.
- Executive summary:
This is a GLP Compliant study following OECD guidelines and is considered adequate for assessment. The average percent biodegradation of the test substance was determined to be 43.87% by day 56. The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 January 2003 - 5 March 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Compliant, guideline study, available as unpublished report, acceptable with restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- yes
- Remarks:
- inoculum preparation which was performed ASTM D5864 and Additional exceptions reported none which would affected the quality or integrity of the study data
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not reported - Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: Activated Slude supernatant
- Details on inoculum:
- Fresh activated sludge from Clinton Sanitary Wastewater Treatment plan, Annandale, New Jersey.
- Duration of test (contact time):
- 28 d
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Triplicate test systems were used to evaluate the biodegradability of the test and positive control substances at mean concentrations of 49.00 mg/L and 47.39 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. The total suspended solids (TSS) of the activated sludge was determined to be 4.41 g/L. The inoculum was added at a 1% loading volume of sludge supernatant to test medium. The microbial count of the inoculum was 106 CFU/mL. One liter of test medium, which was aerated for 24 hours with carbon dioxide free air, was added to each one liter respirometer flask. The test substance was weighed in an air tight syringe and injected into the test medium. The test system was sealed immediately after addition of the test substance. An aliquot of the positive control stock solution was added to the appropriate test flasks. An unacclimated activated sludge inoculum was used in this study. The inoculum was obtained from the Clinton Sanitary Wastewater Treatment Plant, Annandale, NJ, USA. The treatment plant receives domestic sewage. All test systems were placed on a Coordinated Environmental Services (CES) automated respirometer which automatically recorded the oxygen uptake in general agreement with the OECD guideline. The 28-day study was conducted at a temperature range of 21.0°C to 22.2°C.
- Reference substance:
- other: Sodium Benzoate
- Preliminary study:
- Not reported
- Test performance:
- Not reported
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 0
- Sampling time:
- 28 d
- Remarks on result:
- other: No measurable biodegradation observed over a 28 day testing period
- Details on results:
- No measurable biodegradation observed over a 28 day testing period.
- Results with reference substance:
- Biodegradation of positive control substance sodium benzoate measured in triplicate test systems at an average concentration of 47.39 mg/L. Sodium benzoate biodegraded to >60% of the ThOD by day 2.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- DCPD/Codimer Concentrate cannot be considerd readily biodegradable.
- Executive summary:
This study was GLP compliant and followed guidelines. The study is considered adequate for assessment. DCPD/Codimer Concentrate cannot be considerd readily biodegradable as there was no measurable biodegradation observed over a 28 day testing period.
Referenceopen allclose all
Model | Biodegrades fast (No. of consituents) | Does not biodegrade fast (No. of consituents) |
BIOWIN 2 | 118 | 1 |
BIOWIN 3 | 101 | 18 |
BIOWIN 5 | 22 | 97 |
BIOWIN 6 | 55 | 64 |
Description of key information
Three biodegradation studies were available for two streams within this Category. All three studies showed that the streams could not be considered readily biodegradable.
However, of the 119 constituents, and according to the criteria set out in the ECHA R.7b Information Requirements Guidance, 118 (BIOWIN 2), 101 (BIOWIN 3), 22 (BIOWIN 5) and 55 (BIOWIN 6) were predicted to be readily biodegradable based on the different models, with 119 constituents having at least one prediction of a high probability that it will biodegrade fast.
The category is considered inherently biodegradable based on ready biodegradability tests and QSAR data. It is not feasible to perform simulation tests on complex, volatile UVCBs.
Key value for chemical safety assessment
- Biodegradation in water:
- inherently biodegradable
Additional information
Three proprietary studies are available for this Category (ACC, 2007a; 2004a,b).
One of the studies is performed with DCPD/Codimer Concentrate (CAS No. 68478-10-4). This study is GLP compliant and followed OECD guideline 301F and therefore the study is considered adequate for assessment. DCPD/Codimer Concentrate cannot be considered readily biodegradable as there was no measurable biodegradation observed over a 28 day testing period.
Two studies are available for the stream with CAS No. 68477-54-3. Both studies are GLP compliant studies following OECD guideline 301F and are considered adequate for assessment. The average percent biodegradation of the test substance in one of the studies was determined to be 43.87% by day 56. The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory. The average percent biodegradation of the test substance in the other study was determined to be 6.48% on day 41.
The predictions of ready biodegradability of measured constituents of this category (at equal or above 0.1% w/w) have been predicted using the EPISUITE v4.11 BIOWIN models (2017), which use methodology described by Howard et al. (1992), Boethling et al. (1994) and Tunkel et al. (2000). Of the 119 constituents, and according to the criteria set out in the ECHA R.7b Information Requirements Guidance, 118 (BIOWIN 2), 101 (BIOWIN 3), 22 (BIOWIN 5) and 57 (BIOWIN 6) were predicted to be readily biodegradable based on the different models, with 119 constituents having at least one prediction of a high probability that it will biodegrade fast.
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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