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EC number: 297-629-8 | CAS number: 93685-81-5
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2013-10-16 to 2013-11-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to a standard guideline without deviations from the protocol, and was conducted under GLP guidelines.
- Justification for type of information:
- A discussion and report on the read-across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- yes
- Remarks:
- i) pH readings of the test item on day 28 was not taking due to the volatile and oily nature of test substance. (ii) Temperature of incubator for test item and control vessels at days 9, 10 and 11 exceed ±1°C (20-24°C).
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Deviations:
- yes
- Remarks:
- i) pH readings of the test item on day 28 was not taking due to the volatile and oily nature of test substance. (ii) Temperature of incubator for test item and control vessels at days 9, 10 and 11 exceed ±1°C (20-24°C).
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.3110 (Ready Biodegradability)
- Deviations:
- yes
- Remarks:
- i) pH readings of the test item on day 28 was not taking due to the volatile and oily nature of test substance. (ii) Temperature of incubator for test item and control vessels at days 9, 10 and 11 exceed ±1°C (20-24°C).
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- A mixed population of sewage treatment micro-organisms was obtained on 11 October 2013 from the final effluent stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK. The site treats predominantly domestic sewage. Sample of the inoculum was filtered through a coarse filter paper (first approximate 200 ml discarded) and maintained on aeration in a temperature controlled room at 21±1°C before use.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Reference substance:
- aniline
- Preliminary study:
- Preliminary solubility/dispersibility study was performed in order to determine the most suitable method of preparation.
- Test performance:
- Deviations from study plan:
i) The pH readings of the test preparation on Day 28 was not taken due to the potentially volatile and oily nature of the test substance. It was therefore, not possible to determine whether the pH fell within the required range of 6.0 - 8.5. This deviation was considered to have no adverse effect on the integrity of the study given that >60% degradation was achieved.
ii) The incubator temperature where the test substance and toxicity control vessels were placed was observed to exceed the allowed temperature deviation of ±1°C (20-24°C) on Days 9, 10 and 11. The deviation was considered not to have any adverse effect on the outcome of the study because the temperatures were within the specification of the test guideline. - Parameter:
- % degradation (O2 consumption)
- Value:
- 13
- Sampling time:
- 5 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 34
- Sampling time:
- 10 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 50
- Sampling time:
- 15 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 60
- Sampling time:
- 20 d
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 71
- Sampling time:
- 28 d
- Details on results:
- The test substance exhibited rapid biodegradation and assessed as readily biodegradable. By Day 28, the average percent biodegradation of the test substance was 71%. The test substance reached 13% biodegradation on approximately Day 5 and 50% biodegradation on approximately Day 15.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of 79% at Day 28. At Day 14, 63% biodegradation was observed, at Day 20, the biodegradation was 77%.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- A ready biodegradation value of 71% after 28 days was observed for the substance in accordance with OECD 301F and in compliance with GLP. The result is considered reliable.
- Executive summary:
The test substance biodegraded to an extent of 71% after 28 days. The data support characterizing the test substance as readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10 -day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 28 Jul - 25 Aug 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions: The substance is classified as readily biodegradable in the 10 day window although the 10 day window was not passed.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge: obtained from the sewage plant at Hildesheim (Germany), which predominantely treats municipal sewage
- Pretreatment: The activated sludge was washed twice with autoclaved tap water.After the second washing the settled sludge was resuspended in
mineral salts medium and was maintained in an aerobic condition by aeration for 3 hours. Thereafter the sludge was homogenized with a blender . The supernatant was decanted and was maintained in an aerobic condition by aeration with CO2-free air for 4 days. Then it was filtered through a fol ded filter and aeration continued for 1 day until test start. 10 mL/L were used to intiate inoculation.
- Initial cell/biomass concentration: 10E5 - 10E8 CFU/L
- Water filtered: yes
- Type and size of filter used, if any: folded filter - Duration of test (contact time):
- 28 d
- Initial conc.:
- 20 mg/L
- Based on:
- TOC
- Initial conc.:
- 23.5 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium: mineral medium according to guideline
- Test temperature: 20 - 22 °C
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: 120 mL headspace flasks
- Number of culture flasks/concentration: 3 (test end 5 replicates)
- Method used to create aerobic conditions:
- Measuring equipment: Determination of CO2 was carried out by IC analysis with a carbon analyser according to DIN EN 1484
- Other: The test vessels were stirred throught the test (150 - 200 rpm) at low light conditions
SAMPLING
- Sampling frequency: at day 0, 1, 5, 7, 9, 14, 21 and 28
- Sampling method: Sodium hydroxide solution (0.74 mL 7 mol/L solution to 80 mLmedium) was injected to each vessel sampled. The vessels were shaken on an overhead shaker (100 rpm) for 1 h at test temperature. Suitable volumes of the liquid phase were analyzed.
CONTROL AND BLANK SYSTEM
- Abiotic sterile control: yes - Reference substance:
- benzoic acid, sodium salt
- Remarks:
- 17.5 mg TOC/L
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 78
- Sampling time:
- 28 d
- Remarks on result:
- other: CI: 77 - 79%
- Details on results:
- 7d: 52%
14d: 61%
21d: 68% - Results with reference substance:
- The percentage degradation of the functional control reached the pass level of 60% after 4 days and came to 90% after 28 days. The 95% confidence interval on day 28 was 88 - 92%.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable, but failing 10-day window
- Conclusions:
- The test substance reached a biodegradation of 78% in 28 days. The 10-day-window was not passed. However, for substances with different chain lengths the 10-day window should not be used for the interpretation of the results. Therefore, the test substance is judged to be readily biodegradable.
- Executive summary:
The ready biodegradability of the test substance was tested according to OECD guideline 310 under GLP conditions. Non-adapted municipal activated sludge was used as inoculum. The test substance was tested at a concentration of 23.5 mg/L in triplicates.
The 10% level was reached after 2 days and the 60% pass level after 14 days. Thus, the 10-day-window was not achieved (according to biodegradation curve). According to “OECD Guidelines for the testing of chemicals – Revised introduction to the OECD guidelines for testing of chemicals, Section 3 – Part 1: Principles and strategies related to the testing of degradation of organic chemicals degradation” published by OECD (2006) the ready biodegradability data for mixtures should be evaluated carefully. For substances with different chain lengths the 10-day window should not be used for the interpretation of the results. It is possible that a sequential biodegradation took place which might have led to a prolonged lag-Phase and therefore a slower biodegradation period although the test substance was biodegraded in a large amount after the test duration. In this case the pass level can be applied at 28 days. The test substance was biodegraded 78% after 28 days. Therefore, the test substance is readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- December 1996 to February 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Details on inoculum:
- The non acclimated activated sludge inoculum used in this study was obtained from a domestic wastewater treatment plant, in New Jersey, USA.
- Duration of test (contact time):
- 70 d
- Initial conc.:
- 49 - 57 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Triplicate test systems were used to evaluate the biodegradability of the test substance at concentrations of 49-57 mg/L. Duplicate test systems were used to evaluate the positive control substance at an approximate concentration of 51 mg/L. Blank test systems, which did not contain the test or positive control substance, were run concurrently.
The total suspended solids (TSS) of the activated sludge was 3.02 g/L of and the microbial count was 10E6 CFU/mL. The sludge supernatant was added at a 1% loading volume of to test medium. Test medium and activated sludge were prepared 24 hours before addition to the test systems. An un-acclimated activated sludge inoculum was used in this study. The inoculum was obtained from the a domestic wastewater treatment plant in New Jersey, USA. The study was conducted at a temperature of 22 ± 1 degrees C. - Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 10.5
- St. dev.:
- 1.4
- Sampling time:
- 18 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 22.4
- St. dev.:
- 2.3
- Sampling time:
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 43.4
- St. dev.:
- 2.5
- Sampling time:
- 56 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 50.1
- St. dev.:
- 3.3
- Sampling time:
- 70 d
- Details on results:
- The test material was not readily biodegradable. The test material reached 10% biodegradation on day 18 of the test. By Day 70, the average percent biodegradation of the triplicate test systems was 50%, which represtents the half-life for this study.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance.
Interval results for the test substance are as follows:
Day % Degradation % Degradation
Non Acclimated Test Acclimated Test
(mean of quadruplicate systems) (mean of quadruplicate systems)
3 0.24 0.35
7 0.53 13.1
13 10.6 25.9
18 19.4 32.7
25 28.3 39.5
28 31.3 41.7
41 40.5 47.5 - Results with reference substance:
- The reference substance biodegraded to an extent of 86% after 28 days. By Day 3, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid. These data were contained in the laboratory notebook.
- Interpretation of results:
- inherently biodegradable
- Conclusions:
- The test substance biodegraded to an extent of 22% after 28 days and 50% after 70 days. The test substance is not readily biodegradable, but can be considered inherently biodegradable.
- Executive summary:
The test substance biodegraded to an extent of 22% after 28 days and 50% after 70 days. The test substance is not readily biodegradable, but can be considered inherently biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- February to March 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- An un-acclimated activated sludge inoculum was used in this study. The inoculum was obtained from a domestic wastewater treatment plant, in New Jersey, USA.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- ca. 39 - <= 40 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Triplicate test systems were used to evaluate the biodegradability of the test substance at concentrations of 39 to 40 mg/L. Duplicate test systems were used to evaluate the positive control substance at an approximate concentration of 51 mg/L. Blank test systems, which did not contain the test or positive control substance, were run concurrently.
- Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 7.1
- St. dev.:
- 6.3
- Sampling time:
- 6 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 12.4
- St. dev.:
- 8.2
- Sampling time:
- 7 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 47.8
- St. dev.:
- 11
- Sampling time:
- 24 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 52.2
- St. dev.:
- 9
- Sampling time:
- 27 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 53.4
- St. dev.:
- 8.5
- Sampling time:
- 28 d
- Remarks on result:
- other: Percent biodegradation was still increasing.
- Details on results:
- The test substance exhibited moderately rapid biodegradation, and assessed as inherently biodegradable. The half-life was approximately 27 days. By Day 28, the average percent biodegradation of the test substance was 53.4%. The test substance reached approximately 10% biodegradation on Day 7.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of 94.2% (s.d. = 2.5) after 28 days. By Day 4, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid. These data were contained in the laboratory notebook.
- Interpretation of results:
- inherently biodegradable
- Conclusions:
- The test substance biodegraded to an extent of 53% after 28 days. The data support characterizing the test material as exhibiting moderate rate of biodegradation (inherently biodegradable).
- Executive summary:
The test substance biodegraded to an extent of 53% after 28 days. The data support characterizing the test material as exhibiting moderate rate of biodegradation (inherently biodegradable).
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- April to May 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol, and was conducted under GLP guidelines.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- An un-acclimated activated sludge inoculum was used in this study. The inoculum was obtained from the Chester Sewage Works, Welch Water, Cheshire, UK. The treatment plant receives predominantly domestic sewage. The sludge was collected the day before test initiation. It was prepared for the test by homogenizing it for two minutes after which it was allowed to settle and the supernatant coarse-filtered through medical gauze. The supernatant was added at a 1% loading volume to the test medium and aerated with moist air at the test temperature for approximately 25 hours. Test medium consisted of glass distilled water and mineral salts (phosphate buffer, ferric chloride, magnesium sulfate, calcium chloride). 500 ml of test medium and activated sludge were added to each respirometer flask.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 100 mg/L
- Based on:
- ThOD/L
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Triplicate test systems were used to evaluate the biodegradability of the test substance and duplicate test systems were used to evaluate the biodegradability of the positive control substance at mean concentrations of 100 mg/L as ThOD. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. The test substance was added to the test systems with a syringe and injected into the test medium below the surface. The test system was sealed immediately after addition of the test substance to prevent its evaporation. An aliquot of the positive control stock solution was added to the appropriate test flasks. All test vessels were stirred constantly using magnetic stir bars and plates. The test systems ranged in temperature from 20.2 – 20.3°C during the study period.
- Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Test performance:
- No deviations from the protocol occurred that affected the integrity of the study data.
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 10
- Sampling time:
- 5 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 50
- Sampling time:
- 7 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 52
- Sampling time:
- 14 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 61
- Sampling time:
- 20 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 80
- St. dev.:
- 6
- Sampling time:
- 28 d
- Details on results:
- The test substance exhibited rapid biodegradation and assessed as readily biodegradable. The half-life was approximately 14 days. By Day 28, the average percent biodegradation of the test substance was 80%. The test substance reached 10% biodegradation on approximately Day 5 and 60% biodegradation on approximately Day 20.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of 101% after 28 days. By Day 2, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics, biodegraded 80% after 28 days under the conditions of the study and is readily biodegradable.
- Executive summary:
Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, biodegraded to an extent of 80% after 28 days. The data support characterizing the test substance as rapidly biodegradable, readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10 -day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August to September 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- An un-acclimated activated sludge inoculum was used in this study. The inoculum was obtained from a domestic wastewater treatment plant, in New Jersey, USA.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- ca. 45 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Triplicate test systems were used to evaluate the biodegradability of the test substance at an approximate concentration of 45 mg/L. Duplicate test systems were used to evaluate the positive control substance at an approximate concentrations of 50 mg/L. Blank test systems, which did not contain the test or positive control substance, were run concurrently.
- Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 32.3
- Sampling time:
- 3 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 50.9
- Sampling time:
- 5 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 64.4
- Sampling time:
- 10 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 83.1
- Sampling time:
- 28 d
- Remarks on result:
- other: Percent biodegradation was still increasing.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 85.5
- Sampling time:
- 32 d
- Details on results:
- The test substance exhibited rapid biodegradation, and was assessed as readily biodegradable. The half-life was approximately 5 days. By Day 32, the average percent biodegradation of the test substance was 85.5%. The test substance reached 10% biodegradation before Day 3, the first data point, and approximately 60% biodegradation on Day 10.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of 88.8% (s.d. = 0.1) after 28 days. By Day 3, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid. These data were contained in the laboratory notebook.
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance biodegraded to an extent of 83% after 28 days and 86% after 32 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
- Executive summary:
The test substance biodegraded to an extent of 83% after 28 days and 85% after 32 days. The data support characterizing the test substance as rapidly biodegradable (readily biodegradable).
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- February to March 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol and conducted under GLP guidelines.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Duration of test (contact time):
- 30 d
- Initial conc.:
- 37 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Duplicate test systems were used to evaluate the biodegradability of the test substance at a concentration of 37 mg/L. One test system was used to evaluate the positive control substance at a concentration of approximately 31 mg/L. Duplicate blank test systems, which did not contain the test or positive control substance, were run concurrently.
- Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 10
- Sampling time:
- 3 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 50
- Sampling time:
- 9 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 61.3
- Sampling time:
- 12 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 76.6
- Sampling time:
- 28 d
- Remarks on result:
- other: Percent biodegradation was still increasing.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 76.6
- Sampling time:
- 30 d
- Details on results:
- The test substance exhibited rapid biodegradation, and was assessed as readily biodegradable. The half-life was approximately 9 days. By Day 30, the average percent biodegradation of the test substance was 76.6%. The test substance reached 10% biodegradation on Day 3, and approximately 60% biodegradation on Day 12.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of 88% after 28 days. By Day 5, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid.
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance biodegraded to an extent of approximately 77% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
- Executive summary:
The test substance biodegraded to an extent of approximately 77% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- August to September 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol and was conducted under GLP guidelines.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- An un-acclimated activated sludge inoculum was used in this study. The inoculum was obtained from the Somerset Raritan Valley Sewage Authority, Bridgewater, New Jersey, USA. The treatment plant receives predominantly domestic sewage. The sewage sample was obtained one day prior to test initiation. The microbial count was 106 CFU/mL. The sludge supernatant was added at a 1% loading volume of to test medium. Test medium consisted of glass distilled water and mineral salts (phosphate buffer, ferric chloride, magnesium sulfate, calcium chloride). One liter of test medium and activated sludge, which was aerated for 24 hours with carbon dioxide free air, was added to each one liter respirometer flask.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- ca. 38 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Triplicate test systems were used to evaluate the biodegradability of the test substance and the positive control substance at mean concentrations of approximately 38 mg/L and 50 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. 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 vessels were stirred constantly using magnetic stir bars and plates. The study was conducted at a temperature of 21°C.
- Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Test performance:
- No deviations from the protocol occurred that affected the integrity of the study data.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 4.8
- Sampling time:
- 2 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 12.7
- Sampling time:
- 3 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 53
- Sampling time:
- 12 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 60.2
- Sampling time:
- 18 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 67.6
- Sampling time:
- 28 d
- Remarks on result:
- other: Percent biodegradation was still increasing.
- Details on results:
- The test substance exhibited rapid biodegradation, and assessed as readily biodegradable. The half-life was approximately 12 days. By Day 31, the average percent biodegradation of the test substance was 68.7%. The test substance reached 10% biodegradation on approximately Day 3 and 60% biodegradation on approximately Day 18.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of 88.7% after 28 days. By Day 3, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable, but failing 10-day window
- Conclusions:
- The test substance, a multi-component substance, biodegraded to an extent of 68% after 28 days and 69% after 31 days. The data support characterizing the test substance as rapidly biodegradable, readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
- Executive summary:
The test substance, a multi-component substance, biodegraded to an extent of 68% after 28 days and 69% after 31 days. The data support characterizing the test substance as rapidly biodegradable, readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July to August 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol and conducted under GLP guidelines.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Duration of test (contact time):
- 38 d
- Initial conc.:
- 49.4 mg/L
- Based on:
- other: test mat., replicate 1
- Initial conc.:
- 32 mg/L
- Based on:
- other: test mat., replicate 2
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Duplicate test systems were used to evaluate the biodegradability of the test substance at a concentration of 49.4 mg/L. One test system was used to evaluate the positive control substance at a concentration of 40.6 mg/L. Duplicate blank test systems, which did not contain the test or positive control substance, were run concurrently.
- Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 10
- Sampling time:
- 2 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 50
- Sampling time:
- 8 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 63
- Sampling time:
- 12 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 79
- Sampling time:
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 79
- Sampling time:
- 38 d
- Details on results:
- The test substance exhibited rapid biodegradation, and was assessed as readily biodegradable. The half-life was approximately 8 days. By Day 38, the average percent biodegradation of the test substance was 79%. The test substance reached 10% biodegradation on Day 2, and approximately 60% biodegradation on Day 12.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of approximately 90% after 28 days. By Day 4, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid.
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance biodegraded to an extent of approximately 79% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
- Executive summary:
The test substance biodegraded to an extent of approximately 79% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July to August 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline without deviations from the protocol and conducted under GLP guidelines.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Duration of test (contact time):
- 38 d
- Initial conc.:
- 45 mg/L
- Based on:
- other: test mat., replicate 1
- Initial conc.:
- 30.6 mg/L
- Based on:
- other: test mat., replicate 2
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Duplicate test systems were used to evaluate the biodegradability of the test substance at a concentration of 45 mg/L. One test system was used to evaluate the positive control substance at a concentration of approximately 40.6 mg/L. Duplicate blank test systems, which did not contain the test or positive control substance, were run concurrently.
- Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- A preliminary study was not conducted.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 27.8
- Sampling time:
- 3 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 50
- Sampling time:
- 7 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 60.7
- Sampling time:
- 10 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- ca. 80
- Sampling time:
- 28 d
- Remarks on result:
- other: Percent biodegradation was still increasing.
- Parameter:
- % degradation (O2 consumption)
- Value:
- 79.8
- Sampling time:
- 38 d
- Details on results:
- The test substance exhibited rapid biodegradation, and was assessed as readily biodegradable. The half-life was approximately 7 days. By Day 38, the average percent biodegradation of the test substance was 79.8%. The test substance reached 10% biodegradation before Day 2, and approximately 60% biodegradation on Day 10.
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance. - Results with reference substance:
- The reference substance biodegraded to an extent of 90% after 28 days. By Day 3, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid.
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance biodegraded to an extent of approximately 80% after 28 days and 38 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
- Executive summary:
The test substance biodegraded to an extent of approximately 80% after 28 days and 38 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March to April 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 796.3100 (Aerobic Aquatic Biodegradation)
- Deviations:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Duration of test (contact time):
- 31 d
- Initial conc.:
- >= 22.97 - <= 23.35 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 0
- Sampling time:
- 3 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 2.47
- Sampling time:
- 8 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 5.44
- Sampling time:
- 16 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 7.34
- Sampling time:
- 24 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 8.74
- Sampling time:
- 31 d
- Details on results:
- The positive control, sodium benzoate, biodegraded to 60.15% on day 16, 63.62% on day 24, and 65.70% on day 31.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- Interpretation of results:
- not inherently biodegradable
- Conclusions:
- The test substance biodegraded to an extent of 7.34% after 24 days and 8.74% after 31 days. The test substance is not inherently biodegradable.
- Executive summary:
The test substance biodegraded to an extent of 7.34% after 24 days and 8.74% after 31 days. The test substance is not inherently biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March to April 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 796.3100 (Aerobic Aquatic Biodegradation)
- Deviations:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Duration of test (contact time):
- 31 d
- Initial conc.:
- >= 22.55 - <= 23.45 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 1.74
- Sampling time:
- 3 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 5.66
- Sampling time:
- 8 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 13.63
- Sampling time:
- 16 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 16.07
- Sampling time:
- 24 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 18.39
- Sampling time:
- 31 d
- Details on results:
- The positive control, sodium benzoate, biodegraded to 60.15% on day 16, 63.62% on day 24, and 65.70% on day 31.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- Interpretation of results:
- not inherently biodegradable
- Conclusions:
- The test substance biodegraded to an extent of 16.07% after 24 days and 18.39% after 31 days. The test substance is not inherently biodegradable.
- Executive summary:
The test substance biodegraded to an extent of 16.07% after 24 days and 18.39% after 31 days. The test substance is not inherently biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March to April 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 796.3100 (Aerobic Aquatic Biodegradation)
- Deviations:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Duration of test (contact time):
- 31 d
- Initial conc.:
- >= 23.3 - <= 23.98 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 5.03
- Sampling time:
- 3 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 8.69
- Sampling time:
- 8 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 11.69
- Sampling time:
- 16 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 12.69
- Sampling time:
- 24 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 13.69
- Sampling time:
- 31 d
- Details on results:
- The positive control, sodium benzoate, biodegraded to 60.15% on day 16, 63.62% on day 24, and 65.70% on day 31.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- Interpretation of results:
- not inherently biodegradable
- Conclusions:
- The test substance biodegraded to an extent of 12.69% after 24 days and 13.69% after 31 days. The test substance is not inherently biodegradable.
- Executive summary:
The test substance biodegraded to an extent of 12.69% after 24 days and 13.69% after 31 days. The test substance is not inherently biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March to April 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a standard guideline, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 796.3100 (Aerobic Aquatic Biodegradation)
- Deviations:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Duration of test (contact time):
- 31 d
- Initial conc.:
- >= 23.11 - <= 23.24 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 2.88
- Sampling time:
- 3 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 7.37
- Sampling time:
- 8 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 13.88
- Sampling time:
- 16 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 16.95
- Sampling time:
- 24 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 20.62
- Sampling time:
- 31 d
- Details on results:
- The positive control, sodium benzoate, biodegraded to 60.15% on day 16, 63.62% on day 24, and 65.70% on day 31.
- Validity criteria fulfilled:
- yes
- Remarks:
- The test was conducted without a negative control, but this does not invalidate the results.
- Interpretation of results:
- not inherently biodegradable
- Conclusions:
- The test substance biodegraded to an extent of 16.95% after 24 days and 20.62% after 31 days. The test substance is not inherently biodegradable.
- Executive summary:
The test substance biodegraded to an extent of 16.95% after 24 days and 20.62% after 31 days. The test substance is not inherently biodegradable.
Referenceopen allclose all
Results:
Daily BOD values for the test substance, procedure control, toxicity control and inoculum control vessels are in Table 1. The percentage biodegradation values of the test and reference substance and toxicity controls are shown in Table 3 below. The pH results are in Table 2.
Table 3: Biodegradation values
Day |
Procedure control |
Test item |
|
Toxicity control |
|
|
|
R1 |
R2 |
Mean |
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
2 |
1 |
0 |
4 |
0 |
3 |
7 |
5 |
2 |
5 |
1 |
12 |
13 |
13 |
7 |
6 |
1 |
17 |
19 |
18 |
10 |
7 |
1 |
21 |
24 |
23 |
18 |
8 |
1 |
24 |
29 |
27 |
31 |
9 |
1 |
27 |
33 |
30 |
40 |
10 |
1 |
30 |
37 |
34 |
45 |
11 |
4 |
33 |
41 |
37 |
50 |
12 |
20 |
36 |
45 |
41 |
55 |
13 |
49 |
39 |
48 |
44 |
59 |
14 |
63 |
42 |
51 |
47 |
62 |
15 |
68 |
45 |
54 |
50 |
64 |
16 |
71 |
47 |
56 |
52 |
66 |
17 |
73 |
49 |
58 |
54 |
68 |
18 |
75 |
51 |
60 |
56 |
69 |
19 |
76 |
53 |
62 |
58 |
70 |
20 |
77 |
55 |
64 |
60 |
72 |
21 |
77 |
56 |
66 |
61 |
73 |
22 |
78 |
58 |
68 |
63 |
73 |
23 |
78 |
59 |
70 |
65 |
74 |
24 |
78 |
61 |
72 |
67 |
75 |
25 |
78 |
62 |
73 |
68 |
76 |
26 |
79 |
63 |
74 |
69 |
77 |
27 |
79 |
64 |
75 |
70 |
77 |
28 |
79 |
65 |
76 |
71 |
78 |
R1, R2= Replicates 1 and 2
Validation criteria:
The mean BOD of the inoculated mineral medium (control) was 33.72 mg O2/L after 28 days and therefore satisfied the validation criterion of the test guideline.
The difference between extremes of replicate BOD values at the end of the test and at the end of the 10-day window was <20% and therefore satisfied the validation criterion of the test guideline.
Biodegradation:
The test item achieved 71% biodegradation after 28 days and is therefore considered readily biodegradable.
The toxicity control attained 62% biodegradation after 14 days and 78% biodegradation after 28 days, thereby confirming that the test item was not toxic to the sewage treatment micro-organisms used during the study.
Aniline (procedure control) attained 63% biodegradation after 14 days and 79% biodegradation after 28 days thereby confirming the suitability of the inoculum and test conditions.
Chemical analysis of the 100 mg/l test preparation at 0 hours, showed that a mean measured concentration of 97% of nominal was obtained. A decline in measured test concentration was observed at day 28 to 1% of nominal (96% loss over test duration).
The losses observed by chemical analysis were higher that those observed by oxygen consumption, this was considered to be due to possible losses of the test substance due to its volatility during sampling and analytical procedures.
Another factor in the apparent reduced biodegradation value based on oxygen consumption values compared to losses calculated from the chemical analysis conducted may be due to incorporation of the test substance or degradation products of the test substance into the microbial biomass. In such cases, the micro-organisms present utilise carbon originating from the test substance to increase their biomass by incorporating the carbon into new cells. This effectively removes the test substance from the aqueous phase and hence reduces the apparent biodegradation of the test item by oxygen consumption.
Description of key information
There is no data available for this substance. However, key data is available for structural analogues Hydrocarbons, C12-C15, n-alkanes, isoalkanes, <2% aromatics ; Hydrocarbons, C11-C13 (odd numbered), n-alkanes, <2% aromatics; Hydrocarbons, C12-C16, isoalkanes, cyclics, <2% aromatics; Hydrocarbons, C9-C11, cyclics, <2% aromatics; Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics; Tridecane; Hydrocarbons, C11-C12, n-alkanes, <2% aromatics; Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, <2% aromatics; Hydrocarbons, C13-C14, n-alkanes, <2% aromatics; Tetradecane; Hydrocarbons, C10-C12, isoalkanes, cyclics, <2% aromatics; Hydrocarbons, C10-C14, isoalkanes, cyclics, <2% aromatics; Hydrocarbons, C12-C13, isoalkanes, cyclics, <2% aromatics; and Hydrocarbons, C11-C14, n-alkanes, isoalkanes; cyclics, <2% aromatics and presented in the dossier. The data is read across to this substance based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
Based on the available data, this substance is considered readily biodegradable. Key information is summarised below:
Hydrocarbons, C12-C15, n-alkanes, isoalkanes < 2% aromatics presented a ready biodegradation value of 71% after 28 days in accordance with OECD 301F and in compliance with GLP, and it is judged to be readily biodegradable.
Hydrocarbons, C11-C13 (odd number), n-alkanes, <2% aromatics reached a biodegradation of 78% in 28 days. The 10-day-window was not passed. However, for substances with different chain lengths the 10-day window should not be used for the interpretation of the results. Therefore, the test substance is judged to be readily biodegradable.
Hydrocarbons, C12-C16, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 22% after 28 days and 50% after 70 days. The test substance is not readily biodegradable, but can be considered inherently biodegradable.
Hydrocarbons, C9-C11, cyclics, <2% aromatics biodegraded to an extent of 53% after 28 days. The data support characterizing the test material as exhibiting moderate rate of biodegradation (inherently biodegradable).
Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics biodegraded 80% after 28 days under the conditions of the study and is readily biodegradable.
Tridecane biodegraded to an extent of 83% after 28 days and 86% after 32 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
Hydrocarbons, C11-C12, n-alkanes, <2% aromatics biodegraded to an extent of approximately 77% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 68% after 28 days and 69% after 31 days. The data support characterizing the test substance as readily biodegradable. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
Hydrocarbons, C13-C14, n-alkanes, <2% aromatics biodegraded to an extent of approximately 79% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
Tetradecane biodegraded to an extent of approximately 80% after 28 days and 38 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
Hydrocarbons, C10-C12, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 7.34% after 24 days and 8.74% after 31 days. The test substance is not inherently biodegradable.
Hydrocarbons, C10-C14, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 16.07% after 24 days and 18.39% after 31 days. The test substance is not inherently biodegradable.
Hydrocarbons, C12-C13, isoalkanes, cyclics, <2% aromatics biodegraded to an extent of 12.69% after 24 days and 13.69% after 31 days. The test substance is not inherently biodegradable.
Hydrocarbons, C12-C16, isoalkanes, cyclics, < 2% aromatics biodegraded to an extent of 16.95% after 24 days and 20.62% after 31 days. The test substance is not inherently biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
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