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EC number: 208-536-9 | CAS number: 532-40-1
- 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:
- 30 Nov - 28 Dec 2016
- 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:
- 17 Jul 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Version / remarks:
- May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany (24 Sep 2013)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge: Activated sludge from the aeration tank of aomestic wastewater treatment plant, Rossdorf, Germany
- Storage conditions: aerobic
- Storage length: overnight
- Preparation of inoculum for exposure: The activated sludge used for this study was settled for 30 min before it was washed by centrifugation and the supernatant liquid phase decanted. The solid material was re-suspended in test water and centrifuged again. This procedure was performed three times. The sediment of the last washing was resuspended in test water and aerated overnight until use. An aliquot of this final sludge suspension was weighed, dried and the ratio of wet sludge to its dry weight determined. Based on this ratio, calculated aliquots of washed sludge suspension, corresponding to 3.5 g dry material per L (± 10%) were mixed with test water and then aerated until use. This suspension was used for the experiment.
- Concentration of sludge: 3.5 g/L on dry matter base
- Initial cell/biomass concentration: 28.7 mg sludge/L - Duration of test (contact time):
- 28 d
- Initial conc.:
- 102.5 mg/L
- Based on:
- test mat.
- Initial conc.:
- 135 mg/L
- Based on:
- other: ThODNH4
- Initial conc.:
- 210.8 mg/L
- Based on:
- other: ThODNO3
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Reconstituted Test Water, prepared from analytical grade salts.
- Solubilising agent: No emulsifiers or solvents were used.
- Test temperature: 22 ± 1 °C
- pH: 7.3 - 7.6 (at the start of the test), 6.9 - 8.3 (at the end of the test)
- Suspended solids concentration: 28.7 mg sludge/L
- Continuous darkness: Yes.
TEST SYSTEM
- Culturing apparatus: BSB/BOD-Sensor-System, Aqualytic, Dortmund, Germany
- Number of culture flasks/concentration: 2
- Measuring equipment: BSB/BOD-Sensor-System, Aqualytic, Dortmund, Germany
- Test performed in closed vessels due to significant volatility of test substance:
- Test performed in open system: The test flasks were closed gas-tight by a measuring head.
- Details of trap for CO2 and volatile organics if used: A potassium hydroxide solution (45%) was used for trapping the produced carbon dioxide.
SAMPLING
- Sampling frequency: The change of pressure in the test flasks was measured by means of a manometric method each day. The temperature was recorded by means of the automated software AMR Wincontrol. pH values were measured in the procedure control, a separately prepared test flask with test item (to prevent loss of test item in the test flasks) and a separately prepared test flask without test item (control) at test start and in all flasks at the end of the test, except in the abiotic and toxicity control, using a pH-electrold WTW pH 340i.
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 replicates: activated sludge in test water.
- Abiotic sterile control: 1 replicate: test item and CuSO4 in test water.
- Toxicity control: 1 replicate: test item, reference item and activated sludge in test water.
- Procedure control: 1 replicate: reference item and activated sludge in test water. - Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (O2 consumption)
- Value:
- 39
- Sampling time:
- 28 d
- Remarks on result:
- other: ThODNH4
- Parameter:
- % degradation (O2 consumption)
- Value:
- 25
- Sampling time:
- 28 d
- Remarks on result:
- other: ThODNO3
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to "Any other information on results incl. tables".
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The degradation rate of the test item did not reach 60% within the 10-day window or after 28 d (OECD test 301 F). Therefore, the substance is not considered readily biodegradable, according to the OECD criteria. The procedure control with the reference item confirmed the suitability of the activated sludge. In the toxicity control, degradation was > 25% after 14 d, indicating that the test item is not inhibitory to activated sludge microorganisms.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to the analogue approach justification document provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- % degradation (O2 consumption)
- Value:
- 39
- Sampling time:
- 28 d
- Remarks on result:
- other: ThODNH4
- Remarks:
- Source: CAS 10023-48-0, Hammesfahr, 2017
- Parameter:
- % degradation (O2 consumption)
- Value:
- 25
- Sampling time:
- 28 d
- Remarks on result:
- other: ThODNO3
- Remarks:
- Source: CAS 10023-48-0, Hammesfahr, 2017
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The target substance is not readily biodegradable according to OECD criteria, based on experimental findings from a structurally closely related source substance (degradation < 60% after 10-d window and after 28 d, OECD 301 F, CAS 10023-48-0); read-across
Referenceopen allclose all
READY BIODEGRADABILITY OF THE TEST ITEM
The degradation rate of the test item did not reach 60% within the 10 -day window or after 28 d. Therefore, the test item is not considered readily biodegradable.
BIODEGRADATION OF THE REFERENCE ITEM
The reference item (sodium benzoate) was sufficiently degraded to 81% after 14 d and to 84% after 28 d of incubation. The percentage biodegradation of the reference item confirms the suitability of the used aerobic activated sludge inoculum.
BIODEGRADATION IN THE TOXICITY CONTROL
In the toxicity control containing both the test item and the reference item (sodium benzoate), 55% (ThODNH4) biodegradation was recorded within 14 d and 76% (ThODNH4) biodegradation after 28 d of incubation (44% and 61% based on ThODNO3). According to the test guidelines, the test item is not considered inhibitory to aerobic activated sludge microorganisms because degradation was > 25% within 14 d.
ABIOTIC CONTROL
The oxygen demand in the abiotic control was 0 mg/L throughout the test duration.
VALIDITY CRITERIA
The test fulfilled the validity criteria of the guideline (Table 1).
Table 1. Validity criteria of OECD guideline 301F.
Criterion from the guideline |
Study results |
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%. |
The difference of duplicate values at days 26 and 28 differed by 3% and 0% (THODNO3) and by 4% and 0% (THODNH4,). |
Yes |
Percentage degradation of the reference compound has reached the pass levels by day 14. |
The reference item sodium benzoate was degraded to more than 60% after 4 days of incubation. |
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. |
The oxygen demand of the inoculum control (medium and inoculum) was 27.5 mg O2/L. |
Yes |
Description of key information
Not readily biodegradable (39% ThODNH4/25% ThODNO3 in 28 d, OECD 301 F); read-across
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
Additional information
There is no study available, in which the ready biodegradability of the target substance 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-1,3-thiazol-3-ium chloride (CAS 532-40-1) was investigated. Therefore, read-across to the structurally and physico-chemically related source substance 2-{3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl}ethyl hydrogen phosphate (CAS 10023-48-0) was conducted in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5. Based on the physico-chemical similarity, the source substance is considered a suitable proxy for the assessment of the ready biodegradability of the target substance. A detailed analogue approach justification is provided in IUCLID section 13 of the technical dossier.
In the available study, the ready biodegradability of the source substance (CAS 10023-48-0) was investigated according to OECD guideline 301 F and GLP. Since the test item contains nitrogen, the evaluation of biodegradation was based on ThODNH4 and ThODNO3. In the manometric respirometry test, 102.5 mg/L test item, corresponding to a theoretical oxygen demand of about 135.0 mg/L ThODNH4 and 210.8 mg/L ThODNO3, was inoculated with 28.7 mg sludge/L for 28 d. The consumption of oxygen during the test was followed by measuring the change of pressure in the flasks. Evolved carbon dioxide was absorbed in an aqueous solution (45%) of potassium hydroxide. A procedure, toxicity and abiotic control were run in parallel.
After 28 d, the mean biodegradation was 39% (ThODNH4) and 25% (ThODNO3). The degradation rate of the test item did not reach 60% within the 10-day window or after 28 d. Therefore, the test item is not readily biodegradable, according to the OECD criteria. The procedure control confirmed the suitability of the activated sludge. The toxicity control reached a degradation of 76% (ThODNH4) and 61% (ThODNO3) after 28 d, indicating that the test item is not inhibitory to activated sludge microorganisms according to the guideline criteria.
Based on the high degree of structural and chemical similarity of the target and source substance, the target substance is expected to exhibit a similar environmental fate as the source substance. Therefore, it can be concluded that the target substance 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-1,3-thiazol-3-ium chloride (CAS 532-40-1) is not readily biodegradable according to OECD guideline criteria.
[Type of water: freshwater]
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