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EC number: 247-415-5 | CAS number: 26021-57-8
- 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
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2020-11-16 to 2021-05-18
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- April 13, 2004.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- The following total number of samples was prepared:
• Preliminary Test (Tier 1): 8 per pH
• Main Test (Tier 2): 18 per pH and temperature
Sampling Procedure and Schedule:
Preliminary Test (Tier 1)
Test Duration:
The incubation was terminated after 5 days.
Sampling of the Test Samples:
For all three pH levels: 0, 3, 24, 120 h
At each sampling point, samples were taken in duplicate.
Main Test (Tier 2)
Test Duration:
The incubation was terminated after
• pH 4: 30 d (20°C), 30 d (30°C), 21 d (50°C)
• pH 7: 30 d (20°C), 30 d (30°C), 21 d (50°C)
• pH 9: 15 d (20°C), 12 d (30°C), 10 d (50°C)
Sampling of the Test Samples:
• pH 4:
o 20°C: 0, 2, 5, 8, 12, 15, 21, 26, 30 d
o 30°C: 0, 2, 5, 8, 12, 15, 21, 26, 30 d
o 50°C: 0, 6 h // 1, 2, 3, 7, 10, 16, 21 d
• pH 7:
o 20°C: 0, 2, 5, 8, 12, 15, 21, 26, 30 d
o 30°C: 0, 2, 5, 8, 12, 15, 21, 26, 30 d
o 50°C: 0, 6 h // 1, 2, 3, 7, 10, 16, 21 d
• pH 9:
o 20°C: 0, 1, 2, 5, 8, 12, 15 d
o 30°C: 0, 4 h // 1, 2, 5, 8, 12 d
o 50°C: 0, 2, 6 h // 1, 2, 3, 4, 7, 10 d
At each sampling point, samples were taken in duplicate.
After each step of sample preparation a procedural recovery was calculated.
Samples were diluted by a factor of 2 with acetonitrile to prevent further degradation of the test item after sampling. - Buffers:
- pH 4: 0.05 M acetate buffer
410 mL acetic acid (0.1 M) was added to 90 mL sodium acetate (0.1 M). The solution was filled up to 1000 mL with pure water.
pH 7: 0.05 M phosphate buffer
296 mL NaOH (0.1 M) was added to 500 mL potassium dihydrogenphosphate (0.1 M). The solution was filled up to 1000 mL with pure water.
pH 9: 0.05 M boric acid buffer
213 mL NaOH (0.1 M) was added to 500 mL boric acid (0.1 M in potassium chloride, 0.1 M). The solution was filled up to 1000 mL with pure water. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Glass flasks (hermetically closed) were used for the test.
- Sterilisation method: Degased buffer solutions were sterilized by microfiltration (0.2 μm) and the used glassware was sterilised using an autoclave (20 min at 121°C) prior to application. A sterility confirmation test was carried out in course of the study. A commercially available dip slide kit was used for a total count of bacteria and to determine the total count of yeast and moulds.
- Lighting: Darkness
- Measures to exclude oxygen: To avoid oxidation the buffer solutions were purged with inert gas (nitrogen) prior to sterilisation.
TEST MEDIUM
- Preparation of test medium: Sterile aqueous solutions buffered at pH 4, 7 and 9.
The pH of each buffer solution was measured with a calibrated pH meter.
- Renewal of test solution: no
- Identity and concentration of co-solvent: none used
- Stock Solution of the Test Item:
Two individual stock solutions (A and B) were prepared in ACN/pure water (20:80, v/v) with a concentration of 2.00 and 2.01 g/L in case of the preliminary test (Tier 1), 2.00 and 2.01 g/L in case of main test (Tier 2) at 20 and 30°C, and 2.00 g/L in case of main test (Tier 2) at 50°C.
- Application Solution of the Test Item: The stock solutions were used.
The final concentration of the test item in the aqueous phase was below 0.01 M or half of its water solubility and the content of organic was ≤ 1% v/v. Each replicate (A and B) was prepared individually.
Treatment Rate:
Preliminary test (Tier 1): 100 mg/L,
Main test (Tier 2): 100 mg/L - Duration:
- 5 d
- Temp.:
- 50 °C
- Remarks:
- Preliminary Test (Tier 1)
- Preliminary study:
- Immediately after application (0 h) recoveries of the samples were as follows:
• Preliminary test (Tier 1): 100.5-108.3% of the nominal applied concentration. Recoveries of the applied concentration were considered acceptable for the preliminary test (Tier 1). Result evaluation was performed based on the nominal concentration. - Test performance:
- Immediately after application (0 h) recoveries of the samples were as follows:
Main test (Tier 2): 109.0-111.9%, 118.2-122.0% and 112.6-115.1% of the nominal applied concentration, for pH 4, 7 and 9 respectively.
In the main test (Tier 2) recoveries were out of the desired range but still below 0.01 M or half of its water solubility. Result evaluation was performed based on the applied concentration (mean concentration at 0 h). - Transformation products:
- not measured
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 10 d
- Remarks on result:
- other: At the end of incubation recoveries (mean) were < LOQ (10% of the applied concentration)
- pH:
- 9
- Temp.:
- 30 °C
- Duration:
- 12 d
- Remarks on result:
- other: At the end of incubation recoveries (mean) were < LOQ (10% of the applied concentration)
- pH:
- 9
- Temp.:
- 20 °C
- Duration:
- 15 d
- Remarks on result:
- other: At the end of incubation recoveries (mean) were < LOQ (10% of the applied concentration)
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 21 d
- Remarks on result:
- other: LOQ (10% of the nominal applied concentration)
- % Recovery:
- 17.3
- pH:
- 7
- Temp.:
- 30 °C
- Duration:
- 30 d
- % Recovery:
- 36.9
- pH:
- 7
- Temp.:
- 20 °C
- Duration:
- 30 d
- % Recovery:
- 17.1
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 21 d
- % Recovery:
- 46.1
- pH:
- 4
- Temp.:
- 30 °C
- Duration:
- 30 d
- % Recovery:
- 65.1
- pH:
- 4
- Temp.:
- 20 °C
- Duration:
- 30 d
- pH:
- 4
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0.015 d-1
- DT50:
- 45.9 d
- pH:
- 4
- Temp.:
- 30 °C
- Hydrolysis rate constant:
- 0.029 d-1
- DT50:
- 24.1 d
- pH:
- 4
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.092 d-1
- DT50:
- 7.5 d
- pH:
- 4
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.021 d-1
- DT50:
- 33.1 d
- Remarks on result:
- other: The hydrolysis rate constant and the corresponding DT50 value was calculated for a temperature of 25°C based on the arrhenius parameters
- pH:
- 7
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0.027 d-1
- DT50:
- 26 d
- pH:
- 7
- Temp.:
- 30 °C
- Hydrolysis rate constant:
- 0.063 d-1
- DT50:
- 11.1 d
- pH:
- 7
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.254 d-1
- DT50:
- 2.7 d
- pH:
- 7
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.041 d-1
- DT50:
- 17 d
- Remarks on result:
- other: The hydrolysis rate constant and the corresponding DT50 value was calculated for a temperature of 25°C based on the arrhenius parameters
- pH:
- 9
- Temp.:
- 20 °C
- Hydrolysis rate constant:
- 0.262 d-1
- DT50:
- 2.7 d
- pH:
- 9
- Temp.:
- 30 °C
- Hydrolysis rate constant:
- 0.436 d-1
- DT50:
- 1.6 d
- pH:
- 9
- Temp.:
- 50 °C
- Hydrolysis rate constant:
- 0.663 d-1
- DT50:
- 1.1 d
- pH:
- 9
- Temp.:
- 25 °C
- Hydrolysis rate constant:
- 0.332 d-1
- DT50:
- 2.1 d
- Remarks on result:
- other: The hydrolysis rate constant and the corresponding DT50 value was calculated for a temperature of 25°C based on the arrhenius parameters
- Other kinetic parameters:
- DT90 (d):
pH4-20°C: 153
pH4-30°C: 79.9
pH4-50°C: 25
pH7-20°C: 86.4
pH7-30°C: 36.8
pH7-50°C: 9.1
pH9-20°C: 8.8
pH9-30°C: 5.3
pH9-50°C: 3.5 - Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
- Executive summary:
The present study investigated the hydrolytic behaviour of Hydroxybenzomorpholine in aqueous solutions buffered at pH 4, 7 and 9 and at three elevated temperature, according to OECD 111 guideline and following GLP. Samples were incubated in the dark.
The preliminary test was first carried out for 5 days at 50°C (Tier 1). At the end of incubation, 19.0 to 55.8% of the applied concentration was found over all pH levels and thus the test item can be stated as hydrolytically unstable.
The main test (Tier 2) was performed at pH 4, 7 and 9, and at 20, 30 and 50°C. For pH 4, the final recoveries (mean) were 65.1%, 46.1% and 17.1% of the applied concentration at 20, 30 and 50°C, respectively. For pH 7, the final recoveries (mean) were 36.9% and 17.3% of the applied concentration at 20 and 30°C, respectively, and < LOQ (10% of the applied concentration) at 50°C. For pH 9, the final recoveries were < LOQ (10% of the applied concentration) at all three temperatures.
Reference
Description of key information
The present study investigated the hydrolytic behaviour of Hydroxybenzomorpholine in aqueous solutions buffered at pH 4, 7 and 9 and at three elevated temperature, according to OECD 111 guideline and following GLP. Samples were incubated in the dark.
The preliminary test was first carried out for 5 days at 50°C (Tier 1). At the end of incubation, 19.0 to 55.8% of the applied concentration was found over all pH levels and thus the test item can be stated as hydrolytically unstable.
The main test (Tier 2) was performed at pH 4, 7 and 9, and at 20, 30 and 50°C. For pH 4, the final recoveries (mean) were 65.1%, 46.1% and 17.1% of the applied concentration at 20, 30 and 50°C, respectively. For pH 7, the final recoveries (mean) were 36.9% and 17.3% of the applied concentration at 20 and 30°C, respectively, and < LOQ (10% of the applied concentration) at 50°C. For pH 9, the final recoveries were < LOQ (10% of the applied concentration) at all three temperatures.
Key value for chemical safety assessment
Additional information
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