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EC number: 203-183-7 | CAS number: 104-19-8
- 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:
- 29 November 2017 to 20 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- EC No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Batch No.of test material: PFW160141
- Purity: 99.5%
- Expiration date of the lot/batch: 30 December 2018
- Stability under test conditions: Room temperature in the dark - Radiolabelling:
- no
- Buffers:
- The test system consisted of buffer solutions at pH’s 4, 7 and 9.
Buffer Solution Specification:
Buffer solution (pH) Components Concentration (mmol dm-3)
4 Citric acid 6
Sodium chloride 4
Sodium hydroxide 7
7 Disodium hydrogen orthophosphate (anhydrous) 3
Potassium dihydrogen orthophosphate 2
Sodium chloride 2
9 Disodium tetraborate 1
Sodium chloride 2
The buffer solutions were passed through a 0.2 µm membrane filter to sterilize and subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen. - Details on test conditions:
- Preparation of the Test Solutions
Stock solutions of test item were prepared at a nominal concentration of 1.0 g/L in the three buffer solutions. The stock solutions were adjusted to the nominal pH of the relevant buffer solution and then split into individual glass vessels, sealed with minimal headspace, for each data point. These sample solutions were shielded from light whilst maintained at the test temperature.
Preliminary Test/Tier 1
Sample solutions at pH 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours.
Tier 2
Results from the Preliminary test/Tier 1 showed it was not necessary to undertake further testing at pH 4, 7 and 9. - Test performance:
- The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 2 to15 mg/L. The results were satisfactory with correlation coefficient (r) of ≥ 0.992 being obtained.
- Transformation products:
- no
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- No significant peaks were observed at the approximate retention time of the test item on analysis of any matrix blank solutions.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Hydrolysis as function of pH of JeffCat TAP has been determined according to OECD guideline 111 under GLP procedure. At pH 4, 7 and 9, a decrease in concentration < 10 % was observed after 5 days (half-life time > 1 year). Hence it was concluded that the test substancel is hydrolytically stable at pH 4, 7 and 9.
Reference
The mean peak areas relating to the standard and sample solutions are shown in Table 1
Table 1:
Solution |
Mean Peak Area |
Standard 10.0 mg/L, pH 4 |
1.397 x 107 |
Standard 10.1 mg/L, pH 4 |
1.457 x 107 |
Initial Sample A, pH 4 |
1.174 x 107 |
Initial Sample B, pH 4 |
1.044 x 107 |
24 Hour Sample A, pH 4 |
1.139 x 107 |
24 Hour Sample B, pH 4 |
1.080 x 107 |
Standard 10.0 mg/L, pH 7 |
1.370 x 107 |
Standard 10.1 mg/L, pH 7 |
1.371 x 107 |
Initial Sample A, pH 7 |
1.068 x 107 |
Initial Sample B, pH 7 |
1.042 x 107 |
24 Hour Sample A, pH 7 |
1.058 x 107 |
24 Hour Sample B, pH 7 |
1.036 x 107 |
Standard 10.0 mg/L, pH 9 |
1.366 x 107 |
Standard 10.1 mg/L, pH 9 |
1.374 x 107 |
Initial Sample A, pH 9 |
1.295 x 107 |
Initial Sample B, pH 9 |
1.276 x 107 |
24 Hour Sample A, pH 9 |
1.303 x 107 |
24 Hour Sample B, pH 9 |
1.276 x 107 |
Standard 10.0 mg/L, pH 4 |
1.397 x 107 |
Standard 10.1 mg/L, pH 4 |
1.400 x 107 |
120 Hour Sample A, pH 4 |
1.108 x 107 |
120 Hour Sample B, pH 4 |
1.116 x 107 |
Standard 10.0 mg/L, pH 7 |
1.389 x 107 |
Standard 10.1 mg/L, pH 7 |
1.402 x 107 |
120 Hour Sample A, pH 7 |
1.110 x 107 |
120 Hour Sample B, pH 7 |
1.080 x 107 |
Standard 10.0 mg/L, pH 9 |
1.377 x 107 |
Standard 10.1 mg/L, pH 9 |
1.404 x 107 |
120 Hour Sample A, pH 9 |
1.361 x 107 |
120 Hour Sample B, pH 9 |
1.335 x 107 |
The test item concentrations at the given time points are shown in the following tables:
Table 2 pH 4 at 50 ºC
Time (Hours) |
Concentration (g/L) |
% of Mean Initial Concentration |
||
A |
B |
A |
B |
|
0 |
0.826 |
0.734 |
- |
- |
24 |
0.801 |
0.760 |
103 |
97.4 |
120 |
0.796 |
0.802 |
102 |
103 |
pH 4 at 50 °C result: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C.
Table 3 pH 7 at 50 ºC
Time (Hours) |
Concentration (g/L) |
% of Mean Initial Concentration |
||
A |
B |
A |
B |
|
0 |
0.782 |
0.763 |
- |
- |
24 |
0.775 |
0.759 |
100 |
98.2 |
120 |
0.798 |
0.777 |
103 |
101 |
pH 7 at 50 °C result: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C.
Table 4 pH 9 at 50 ºC
Time (Hours) |
Concentration (g/L) |
% of Mean Initial Concentration |
||
A |
B |
A |
B |
|
0 |
0.950 |
0.935 |
- |
- |
24 |
0.956 |
0.935 |
101 |
99.3 |
120 |
0.983 |
0.964 |
104 |
102 |
pH 9 at 50 °C result: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C.
Discussion
No significant peaks were observed at the approximate retention time of the test item on analysis of any matrix blank solutions.
Description of key information
One study (Covance, 2019) was performed according to OECD guideline 111 and regarded as a key study (Klimisch score of 1). A half-life time of > 1 year at 25 °C was determined for the test substance.
Key value for chemical safety assessment
Additional information
Hydrolysis was studied in a guideline study (OECD Guideline 111) during 5 days at pH 4, 7 and 9 and at 50°C. Less than 10% hydrolysis was observed at the end of testing at each pH level tested. Based on these results, no further testing was needed and it was concluded that the estimated half-life at 25°C is > 1 yr (substance hydrolytically stable). The results of the test can be considered reliable without restriction.
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