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EC number: 915-761-2 | CAS number: -
- 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
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- 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:
- This study was conducted between 08 November 2017 and 26 Novemebr 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- EC No. 440/82008 of 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Information as provided by the Sponsor.
Identification: FAT 31016/T
CAS Number: 62163-53-5
Physical state:Dark green iridescent liquid
Batch: AT-0042774700
Purity: 80%
Expiry date: 07 September 2021
Storage conditions: Room temperature, in the dark - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate sample solutions were taken initially and from the waterbath at various time points. The pH of each solution was recorded. The concentration of test item in the sample solutions was determined by high performance liquid chromatography (HPLC).
- Buffers:
- The test system consisted of buffer solutions at pH’s 4, 7 and 9, detailed in the following table:
Table 1 Buffer Solution Specification
Buffer solution (pH) Components Concentration (mol dm-3)
4 Citric acid 0.006
Sodium chloride 0.004
Sodium hydroxide 0.007
7 Disodium hydrogen orthophosphate (anhydrous) 0.003
Potassium dihydrogen orthophosphate 0.002
Sodium chloride 0.002
9 Disodium tetraborate 0.001
Sodium chloride 0.002
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:
- Performance of the Test
Preparation of the Test Solutions
Stock solutions of test item were prepared at a nominal concentration of 4000 mg/L in the three buffer solutions. The stock solutions were 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 and 7 were maintained at 50.0 ± 0.5 °C for a period of 120 hours. Sample solutions at pH 9 were maintained at 50.0 ± 0.5 °C for a period of 212 hours.
Analysis of the Sample Solutions
Duplicate sample solutions were taken initially and from the waterbath at various time points. The pH of each solution was recorded. The concentration of test item in the sample solutions was determined by high performance liquid chromatography (HPLC). - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 4 000 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 4 000 mg/L
- Duration:
- 212 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 4 000 mg/L
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Test performance:
- 4.1.5 Validation
The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 40 to 800 mg/L. The results were satisfactory with a correlation coefficient (r) of ≥0.999 being obtained for all pH’s. - Transformation products:
- no
- Key result
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Key result
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Details on results:
- No significant peaks were observed at the approximate retention time of the test item on analysis of any matrix blank solutions.
Greater than 10 % loss of initial test item concentration was observed after 5 days at 50 °C, at pH 9, however no further significant loss was seen after 24 hours. As after the initial decrease in concentration the concentration stabilized, this loss was not attributed to hydrolysis therefore pH 9 reported as a half-life (t ½) of greater than a year. - Validity criteria fulfilled:
- yes
- Conclusions:
- The estimated rate constant and half-life at 25 °C of the test item are shown in the following table:
Table
pH Estimated Half-Life at 25 °C
4 > 1 year
7 > 1 year
9 > 1 year - Executive summary:
The hydrolysis as a function of pH of FAT 31016/T has been determined. The results are summarized below:
Abiotic Degradation, Hydrolysis as a Function of pH. Assessment of hydrolytic stability was carried out using a procedure designed to be compatible with Method C.7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The results are as follows:
pH
Estimated half-life at 25 °C
4
>1 year
7
>1 year
9
>1 year
Reference
Preliminary Test/Tier 1
The mean peak areas relating to the standard and sample solutions are shown in the following tables:
Table 2– Preliminary Testing pH 4 at 50.0 ± 0.5 °C
Solution |
Mean peak area |
Standard 402 mg/L |
1.9216 x 108 |
Standard 416 mg/L |
1.9430 x 108 |
Initial Sample A, pH 4 |
1.8749 x 108 |
Initial Sample B, pH 4 |
1.8765 x 108 |
Standard 411 mg/L |
1.9700 x 108 |
Standard 408 mg/L |
1.9315 x 108 |
24 Hour Sample A, pH 4 |
1.8905 x 108 |
24 Hour Sample B, pH 4 |
1.8928 x 108 |
Standard 402 mg/L |
1.8681 x 108 |
Standard 408 mg/L |
1.8966 x 108 |
120 Hour Sample A, pH 4 |
1.8212 x 108 |
120 Hour Sample B, pH 4 |
1.8382 x 108 |
Table3– Preliminary Testing pH 7 at 50.0 ± 0.5 °C
Solution |
Mean peak area |
Standard 402 mg/L |
1.9226 x 108 |
Standard 416 mg/L |
1.9322 x 108 |
Initial Sample A, pH 7 |
1.6055 x 108 |
Initial Sample B, pH 7 |
1.5938 x 108 |
Standard 411 mg/L |
1.9626 x 108 |
Standard 408 mg/L |
1.9280 x 108 |
24 Hour Sample A, pH 7 |
1.7567 x 108 |
24 Hour Sample B, pH 7 |
1.7600 x 108 |
Standard 402 mg/L |
1.8624 x 108 |
Standard 408 mg/L |
1.8886 x 108 |
120 Hour Sample A, pH 7 |
1.4853 x 108 |
120 Hour Sample B, pH 7 |
1.4751 x 108 |
Table4– Preliminary Testing pH 9 at 50.0 ± 0.5 °C
Solution |
Mean peak area |
Standard 402 mg/L |
1.5920 x 108 |
Standard 416 mg/L |
1.6844 x 108 |
Initial Sample A, pH 9 |
1.8911 x 108 |
Initial Sample B, pH 9 |
1.8888 x 108 |
Standard 411 mg/L |
1.6234 x 108 |
Standard 408 mg/L |
1.6283 x 108 |
24 Hour Sample A, pH 7 |
1.1978 x 108 |
24 Hour Sample B, pH 7 |
1.1977 x 108 |
Standard 402 mg/L |
1.5464 x 108 |
Standard 408 mg/L |
1.5956 x 108 |
120 Hour Sample A, pH 9 |
1.1112 x 108 |
120 Hour Sample B, pH 9 |
1.1191 x 108 |
Standard 400 mg/L |
1.6696 x 108 |
Standard 404 mg/L |
1.6949 x 108 |
144 Hour Sample A, pH 9 |
1.1036 x 108 |
144 Hour Sample B, pH 9 |
1.1036 x 108 |
Standard 400 mg/L |
1.6113 x 108 |
Standard 403 mg/L |
1.6041 x 108 |
212 Hour Sample A, pH 9 |
1.1017 x 108 |
212 Hour Sample B, pH 9 |
1.1031 x 108 |
The test item concentrations at the given time points are shown in the following tables:
Table 5 pH 4 at 50.0 ± 0.5 ºC
Time (Hours) |
Concentration (g/L) |
% of mean initial concentration |
||
A |
B |
A |
B |
|
0 |
3.97 |
3.97 |
- |
- |
24 |
3.97 |
3.98 |
100 |
100 |
120 |
3.92 |
3.96 |
99 |
100 |
Result: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C.
Table 6 pH 7 at 50.0 ± 0.5 ºC
Time (Hours) |
Concentration (g/L) |
% of mean initial concentration |
||
A |
B |
A |
B |
|
0 |
3.41 |
3.38 |
- |
- |
24 |
3.70 |
3.71 |
109 |
109 |
120 |
3.21 |
3.19 |
94 |
94 |
Result: Less than 10% hydrolysis after 5 days at 50 °C, equivalent to a half-life greater than 1 year at 25 °C.
Table 7 pH 9 at 50.0 ± 0.5 ºC
Time (Hours) |
Concentration (g/L) |
% of mean initial concentration |
||
A |
B |
A |
B |
|
0 |
4.73 |
4.72 |
- |
- |
24 |
3.02 |
3.02 |
64 |
64 |
120 |
2.87 |
2.89 |
61 |
61 |
144 |
2.64 |
2.64 |
56 |
56 |
212 |
2.75 |
2.76 |
58 |
58 |
Result: Greater than10% loss after 5 days at 50 °C,however no further significant loss was seen after 24 hours. Therefore no hydrolysis is indicated by the results, providing a hydrolysis equivalent to a half-life greater than 1 year at 25 °C.
Description of key information
FAT 31016/T TE was found to be hydrolytically stable, with half life of >1 year at 25 °C.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
Assessment of hydrolytic stability was carried out using a procedure designed to be compatible with Method C.7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The estimated rate constant and half-life at 25 °C of the test item were determined as follows:
pH Estimated Half-Life at 25 °C
4 > 1 year
7 > 1 year
9 > 1 year
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