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EC number: 700-835-7 | CAS number: 919005-14-4
- 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 10, 2007- July 19, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: guideline study conducted under GLP compliance with acceptable restriction. Study of ammonium salt
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- GLP compliance:
- yes
Test material
- Reference substance name:
- E-19729
- IUPAC Name:
- E-19729
- Details on test material:
- - Name of test material (as cited in study report): E-19729
- Substance type: single-constituent substance
- Physical state: colorless, transparent, viscous liquid
- Analytical purity: approximately 30 % (w/w) aqueous solution
- Lot/batch no.:VV87-10+12
- Expiration date of the lot/batch: December 31, 2008
- Storage condition of test material: Ambient temperature, 10-30°C
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: About 0.60 g of the test item solution was weighed in 50 ml volumetric flasks in a glove box filled with nitrogen. Test bottles with buffers of pH 4, 7 and 9 were sampled at 2.4 hours and 5 days;
- Sampling method: The flasks containing the hydrolysis mixtures were placed in a thermostatically controlled water bath at 50 ± 0.5 °C for 2.4 hours and 5 days. Thereafter aliquots of each flask were taken. The volumetric flasks were flooded with nitrogen again. The aliquots were diluted 0.1 ml to 1 ml with the
mobile phase at the beginning of the HPLC-measurement.
- Sampling intervals/times for pH measurements: None
- Sample storage conditions before analysis: None - Buffers:
- - pH: 4,7,9
- Type and final molarity of buffer:
pH 4 buffer: 21.01 g citric acid monohydrate dissolved in 200 mL of 1 mol/I NaOH solution, and bring to 1000 ml with distilled water. 44 ml of mol/I of HCl
were added to 560 ml of citric acid monohydrate/NaOH and bring to 1000 ml with distilled water. The pH value was adjusted to pH 4.
pH 7 buffer: 13.61 g of KH2PO4 were dissolved in 1000 ml distilled water. 30 ml of 1 mol/I NaOH were added to 500 ml of KH2PO4 solution and bring to 1000 ml with distilled water. The pH was adjusted to pH 7.
pH 9 buffer: 7.46 9 KCl and 6.18 g boric acid (H3BO3) were dissolved in 1000 ml distilled water. 21 ml of 1 mol/I NaOH were added to 500 ml of KCl/H3BO3 solution and bring to 1000 ml with distilled water. The pH value was adjusted to pH 9.
- Composition of buffer:
pH 4 buffer: citric acid monohydrate/NaOH/HCl
pH 7 buffer: KH2PO4/NaOH
pH 9 buffer: KCl /H3BO3/NaOH - Details on test conditions:
- TEST SYSTEM
-Type, material and volume of test flasks, other equipment used: 50 mL volumetric flasks
- Measures to exclude oxygen: test item was weighted in a glove box filled with nitrogen .The volumetric flasks were flooded with nitrogen.
TEST MEDIUM
- Kind and purity of water: distilled water
- Identity and concentration of co-solvent: no co-solvent
OTHER TEST CONDITIONS
- Adjustment of pH: none
- Dissolved oxygen: flooded with nitrogen
Duration of test
- Duration:
- 5 d
- Temp.:
- 50 °C
- Initial conc. measured:
- 12.11 - 12.62 g/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
Results and discussion
- Transformation products:
- not measured
- Details on hydrolysis and appearance of transformation product(s):
- - Formation and decline of each transformation product during test: not measured
The % decomposition at pH 4, pH 7 and pH 9 ranged from 0 to 1.12% after 2.4 hours and 5 days in the hydrolysis pre-tests.
Total recovery of test substance (in %)
- % Recovery:
- 98.88 - 101.54
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 2.4 - 120 h
Dissipation DT50 of parent compound
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Details on results:
- - Formation and decline of each transformation product during test: not measured
Decomposition of test substance E-19729 by hydrolysis was not significant in all pH buffers after 2.4 hours and 5 days at 50 °C. At pH 4, the % of decomposition was 0 to 0.05; at pH 7, the % of decomposition was 0 to 1.12; at pH 9, the % of decomposition was 0 to 0.22. Seven out of twelve measured concentrations at the end of the study were slightly higher than the initial measured concentration, resulting in negative values of % decomposition. However, these values were the results of analytical uncertainty, and were not considered to be statistically different from the initial measured concentrations. Therefore, the % decomposition at pH 4, pH 7 and pH 9 is reported to range from 0 to 1.12% after 2.4 hours and 5 days at 50 °C.
Less than 10 % of the reaction was observed after 5 days at 50°C at pH 4, pH 7 and pH 9; the half life for E-19729 was reported as > 1 year. The test substance is considered to be hydrolytically stable.
Any other information on results incl. tables
Table 1. Results of the hydrolysis of E-19729 |
||||||
Experiment |
pH |
Duration |
C0(g/L) |
Ct(g/L) |
Ct/C0 |
% Decomposition |
1 |
4 |
2.4 h |
12.22 |
12.33 |
1.0091 |
0 |
2.4 h |
12.23 |
12.27 |
1.0034 |
0 |
||
2 |
4 |
5 d |
12.22 |
12.21 |
0.9995 |
0.05 |
5 d |
12.23 |
12.27 |
1.0033 |
0 |
||
3 |
7 |
2.4 h |
12.62 |
12.49 |
0.9895 |
1.05 |
2.4 h |
12.23 |
12.42 |
1.0154 |
0 |
||
4 |
7 |
5 d |
12.62 |
12.48 |
0.9888 |
1.12 |
5 d |
12.23 |
12.2 |
0.9973 |
0.27 |
||
5 |
9 |
2.4 h |
12.31 |
12.45 |
1.0119 |
0 |
2.4 h |
12.11 |
12.19 |
1.0071 |
0 |
||
6 |
9 |
5 d |
12.31 |
12.28 |
0.9978 |
0.22 |
5 d |
12.11 |
12.4 |
1.0244 |
0 |
||
C0 = concentration measured by HPLC at time ) |
||||||
Ct= concentration at time 2.4 h or 5 days |
Applicant's summary and conclusion
- Conclusions:
- E-19729 has a hydrolysis half life of > 1 year, it is considered hydrolytically stable.
- Executive summary:
DONA is an acid that is expected to be deprotonated at pH 4,7,and 9. E-19729 is the ammonium salt of DONA. Hydrolysis data from E-19729 can therefore be used to assess DONA hydrolysis.
Hydrolysis study for E-19729 was performed according to the OECD 111: hydrolysis as a Function of pH.
About 0.60 g of E-19729 was weighed in 50 ml volumetric flasks with buffers of pH 4, 7 and 9 and placed at 50 ± 0.5 °C for 2.4 hours and 5 days. Concentrations of E-19729 at the initial and the end of hydrolysis experiment were measured by HPLC. Hydrolysis rate were determined by % decomposition of the test material.
The % decomposition of E-19729 at pH 4, pH 7 and pH 9 ranged from 0 to 1.12% after 2.4 hours and 5 days at 50°C, the hydrolysis half life is reported as > 1 year. The ammonium salt of DONA is considered hydrolytically stable.
This is a guideline study conducted under GLP. Therefore, it is considered to be reliable with acceptable restriction.
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