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EC number: 205-181-1 | CAS number: 135-16-0
- 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:
- 2017-07-27 to
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- adopted 13 April 2004
- Deviations:
- no
- Principles of method if other than guideline:
- Study was performed to determine the stability of the test substance in different aqueous media to clarify the feasibility and design of experimental studies regarding physico-chemical, environmental fate and ecotoxicological properties.
- GLP compliance:
- no
- Analytical monitoring:
- yes
- Remarks:
- Liquid chromatography and mass spectrometry
- Details on sampling:
- - Sample storage conditions before analysis: 100 mg/L test item was dissolved in buffer solution pH 4, 7 and 9, respectively and analysed directly.
- Buffers:
- - pH: 4, 7 and 9
- Type and final molarity of buffer: n/a
- Composition of buffer: n/a - Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Transformation products:
- yes
- No.:
- #1
- No.:
- #2
- Remarks on result:
- not measured/tested
- Key result
- pH:
- 4
- DT50:
- 0.059 h
- Type:
- not specified
- Remarks on result:
- other: Temperature and Hydrolysis rate constant not reported
- Key result
- pH:
- 7
- DT50:
- 0.257 h
- Type:
- not specified
- Remarks on result:
- other: Temperature and Hydrolysis rate constant not reported
- Key result
- pH:
- 9
- DT50:
- 0.712 h
- Type:
- not specified
- Remarks on result:
- other: Temperature and Hydrolysis rate constant not reported
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- The present study was conducted in order to provide information about the stability of Tetrahydrofolic acid in aqueous solutions. The water solubility could not be determined due to fast hydrolysis of the substance.The half-lifes were determined in 0.01 M CaCl2 solution, in buffer solutions at pH 4, 7 and 9 and in Algae Dilution Medium. T1/2 was 0.4 h in 0.01M CaCl2, and 0.0594 h for pH 4, 0.257 h for pH 7 and 0.712 h for pH 9 with LC-MS. Plots of the stability of Tetrahydrofolic acid in Algae Dilution Medium showed a decline of the parent substances and an increase of two hydrolysis products 2-amino-6-methylpteridin-4(1H)-one and (2S)-2-(4-aminobenzamido)pentanedioic acid.
Reference
Determination of Hydrolysis in Aqueous Phase – pH 4
Nominal concentration, test item: 100 mg/L
pH 4 |
|||
Time [h] |
Peak Area |
ln Peak Area |
% |
0.000 |
33509948 |
17.3 |
- |
0.183 |
675904 |
13.4 |
2 |
0.364 |
179466 |
12.1 |
0.5 |
0.547 |
43528 |
10.7 |
0.1 |
% = percent of initial concentration, t0set to 100%
Hydrolysis in Aqueous Phase – pH 4
pH 4 |
|
Slope of regression graph |
-0.117 |
Correlation factor [r2] |
0.923 |
Reaction rate constantk[1/s] |
3.24 ∙ 10-3 |
Half-lifeT½[h] |
0.0594 |
Half-lifeT½[min] |
3.56 |
Determination of Hydrolysis in Aqueous Phase – pH 7
Nominal concentration, test item: 100 mg/L
pH 7 |
|||
Time [h] |
Peak Area |
ln Peak Area |
% |
0.000 |
56905440 |
17.9 |
- |
0.183 |
29781291 |
17.2 |
52 |
0.3651) |
52813611) |
15.51) |
91) |
0.736 |
7279096 |
15.8 |
13 |
0.919 |
4985612 |
15.4 |
9 |
1.10 |
3174099 |
15.0 |
6 |
1.28 |
1808882 |
14.4 |
3 |
1.47 |
1143522 |
14.0 |
2 |
1.65 |
600828 |
13.3 |
1 |
1.83 |
357862 |
12.8 |
1 |
% = percent of initial concentration, t0set to 100%
1)= outlier, not taken into account
Hydrolysis in Aqueous Phase – pH 7
pH 7 |
|
Slope of regression graph |
-2.70 |
Correlation factor [r2] |
0.997 |
Reaction rate constantk[1/s] |
7.49 ∙ 10-4 |
Half-lifeT½[h] |
0.257 |
Half-lifeT½[min] |
15.4 |
Determination of Hydrolysis in Aqueous Phase – pH 9
Nominal concentration, test item: 100 mg/L
pH 9 |
|||
Time [h] |
Peak Area |
ln Peak Area |
% |
0.000 |
128982791 |
18.7 |
- |
0.183 |
86149063 |
18.3 |
67 |
0.365 |
64018083 |
18.0 |
50 |
0.547 |
50905504 |
17.8 |
39 |
0.730 |
43442552 |
17.6 |
34 |
0.913 |
35485067 |
17.4 |
28 |
1.10 |
30533632 |
17.2 |
24 |
1.28 |
26036767 |
17.1 |
20 |
1.46 |
22208419 |
16.9 |
17 |
1.64 |
19819906 |
16.8 |
15 |
2.01 |
15356634 |
16.6 |
12 |
2.19 |
12085931 |
16.3 |
9 |
2.38 |
10140678 |
16.1 |
8 |
% = percent of initial concentration, t0set to 100%
Hydrolysis in Aqueous Phase – pH 9
pH 9 |
|
Slope of regression graph |
-0.974 |
Correlation factor [r2] |
0.977 |
Reaction rate constantk[1/s] |
2.70 ∙ 10-4 |
Half-lifeT½[h] |
0.712 |
Half-lifeT½[min] |
42.7 |
Description of key information
- study on hydrolysis performed similar to OECD guideline 111, non-GLP test, half-lifes T1/2 was 0.4 h in 0.01M CaCl2, and 0.0594 h for pH 4, 0.257 h for pH 7 and 0.712 h for pH 9 with LC-MS, determination of two hydrolysis products 2-amino-6-methylpteridin-4(1H)-one and (2S)-2-(4-aminobenzamido)pentanedioic acid.
Key value for chemical safety assessment
Additional information
The present study was conducted in order to provide information about the stability of Tetrahydrofolic acid in aqueous solutions. The water solubility could not be determined due to fast hydrolysis of the substance.The half-lifes were determined in 0.01 M CaCl2 solution, in buffer solutions at pH 4, 7 and 9 and in Algae Dilution Medium. T1/2 was 0.4 h in 0.01M CaCl2, and 0.0594 h for pH 4, 0.257 h for pH 7 and 0.712 h for pH 9 with LC-MS. Plots of the stability of Tetrahydrofolic acid in Algae Dilution Medium showed a decline of the parent substances and an increase of two hydrolysis products 2-amino-6-methylpteridin-4(1H)-one and (2S)-2-(4-aminobenzamido)pentanedioic acid.
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