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EC number: 269-642-9 | CAS number: 68308-30-5
- 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
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Remarks:
- Toxicity control of ready biodegradability test.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Mar - 27 Apr 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 301 F
- Version / remarks:
- 17 Jul 1992
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, Japan (22 Dec 2016)
- Analytical monitoring:
- no
- Vehicle:
- yes
- Remarks:
- Silica gel 60 (0.5 g per test vessel filled with 300 mL test solution)
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The toxicity control was prepared by accurately weighing and adding 9 mg test item to the test vessel, which was then heated at 100 °C for 20 min in an oven. Then, 0.5 g Silica gel 60 was added to the test vessel and stirred for 30 min at room temperature. Subsequently, 30 mg of the reference compound sodium benzoate and 3.20 mL activated sludge were added to the test vessels, which was then filled to 300 mL with mineral medium. The final concentration of test item was 30 mg/L and the final concentration of sodium benzoate was 100 mg/L.
- Chemical name of vehicle Silica gel 60
- Concentration of vehicle in test medium: 0.5 g in 300 mL (= 500 mg/0.3 L = 1666.66 mg/L)
- Evidence of undissolved material: No, the state of the test item could not be confirmed because of the presence of silica gel. The test solution was colorless. - Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Name and location of sewage treatment plant where inoculum was collected:
Kurume central sewage treatment center (Kurume, Fukuoka, Japan), 30 Mar 2018
- Method of cultivation: After collection, the activated sludge was aerated at about 22 °C for about 3.5 h until use in the test.
- Initial suspended solids concentration: 30 mg/L - Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 28 d
- Test temperature:
- 22 ± 1 °C
- pH:
- 7.4 (mineral medium)
- Nominal and measured concentrations:
- 30 mg/L test item and 100 mg/L sodium benzoate (nominal)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass vessel with closed system oxygen consumption measuring apparatus
- No. of vessels per concentration (replicates): 2
- No. of vessels per control blank (replicates): 2
- No. of vessels per vehicle control (replicates): 0
- Sludge concentration at test start: 30 mg/L suspended solids
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Mineral medium prepared with purified water (Japanese Pharmacopoeia, Takasugi Pharmaceutical)
OTHER TEST CONDITIONS
- Adjustment of pH: The mineral medium was adjusted to 7.4
- Photoperiod: Incubation in the dark
- Other: Each test solution was stirred with a stirrer and placed in a temperature controlled bath.
EFFECT PARAMETERS MEASURED:
- Biological oxygen demand: Continuous measurement - Reference substance (positive control):
- yes
- Remarks:
- sodium benzoate
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 30 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: biological oxygen demand
- Remarks on result:
- other:
- Remarks:
- The percentage biodegradation was 58% after 14 d.
- Details on results:
- - Any observations that might cause a difference between measured and nominal values:
No, the state of the test item could not be confirmed because of the presence of silica gel. The test solution was colorless.
- Effect concentrations exceeding solubility of substance in test medium: Yes
- Adsorption (e.g. of test material to the walls of the test container): No
- Blank controls oxygen uptake rate: 18 mg/L
- Coefficient of variation of oxygen uptake rate in control replicates: 0 - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: 84% biodegradation of sodium benzoate after 14 d - Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
- Conclusions:
- The average biodegradation of the reference item sodium benzoate in the toxicity control was 58% by BOD after 14 d. Therefore, the test item is not inhibitory to activated sludge microorganisms at the applied concentration level of 30 mg/L.
Reference
In the toxicity control, the percentage biodegradation by BOD was 58% after 14 days. According to the test guideline, if the percentage biodegradation is less than 25% within 14 days, the test item is toxic. Therefore, the test item can be assumed not to be inhibitory to activated sludge microorganisms at the applied concentration level of 30 mg/L.
According to the ECHA guidance R.7b (2017) the information content of a ready biodegradability test can be used to derive a NOEC when a toxicity control has been included that shows good degradation of a positive control substance (e.g. sodium benzoate) in the presence of the test substance.
Description of key information
NOEC ≥ 30 mg/L (nominal, OECD 301 F)
Key value for chemical safety assessment
Additional information
The microbial toxicity of Fatty acids, montan-wax, stearyl esters (EC No. 269-642-9, CAS 68308-30-5) was inferred from the toxicity control of a standard ready biodegradability test conducted according to OECD testing guideline 301 F and GLP, as recommended by the Guidance document “Chapter R.7b Endpoint specific Guidance on Information Requirements and Chemical Safety Assessment (ECHA, 2018) in absence of a microbial toxicity test according to OECD 209.
In the manometric respirometry test, the toxicity control was prepared by inoculating 30 mg/L test item with (0.5 g/300 mL) silica gel 60, 30 mg/L reference item (sodium benzoate) and 30 mg/L activated sludge (suspended solids) in a final volume of 300 mL mineral medium for 28 d in the dark. Biodegradation was followed by continuously measuring the biochemical oxygen demand with a closed system oxygen consumption measuring apparatus.
After 14 d, degradation of the reference item in the toxicity control was 58%and thus above the criterion for inhibition effects to the inoculum (< 25% degradation in 14 d). Based on this result, the test item had no toxic effect on the inoculum and a NOEC (14 d) of ≥ 30.0 mg/L was derived according to the Guidance document “Chapter R.7b Endpoint specific Guidance on Information Requirements and Chemical Safety Assessment” (ECHA, 2017).
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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