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EC number: - | 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
- 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:
- 12 December 2011 to 09 March 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- (2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Analytical purity: 46.2 % (4 main constituents)
- Lot/batch No.: TZ 5719 / BOP 02-11
- Expiration date of the lot/batch: 01 April 2016 - Radiolabelling:
- no
- Analytical monitoring:
- yes
- Buffers:
- Acetate buffer pH 4, 0.1 M: solution of 16.7% (v/v) 0.1 M sodium acetate and 83.3% (v/v) 0.1 M acetic acid. The buffer contains 0.0009% (w/v) sodium azide.
Phosphate buffer pH 7, 0.1 M: solution of 0.1 M potassium dihydrogenphosphate adjusted to pH 7 using 10 N sodium hydroxide. The buffer contains 0.0009 % (w/v) sodium azide.
Borate buffer pH 9, 0.1 M: solution of 0.1 M boric acid and 0.1 M potassium chloride adjusted to pH 9 using 10 N sodium hydroxide. The buffer contains 0.0009 % (w/v) sodium azide. - Details on test conditions:
- Test substance solutions were prepared in the buffer solutions at a target concentration of 137 - 192 mg/l. Each solution was filter-sterilised through a 0.2 µm FP 30/0.2 CA-S filter (Whatman, Germany) and transferred into a sterile vessel. To exclude oxygen, nitrogen gas was purged through the solution for 5 minutes. For each sampling time, duplicate sterile vessels under vacuum were filled with 6 ml test solution and placed in the dark in a temperature controlled environment at 50.1 °C ± 0.1 °C. Blank buffer solutions were treated similarly as the test samples and analysed at t=0. The pH of each of the test solutions (except for the blanks) was determined at each sampling time.
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 147 - 152 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 201 - 204 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 214 - 222 mg/L
- Number of replicates:
- For each sampling time, duplicate sterile vessels under vacuum were filled with test solution.
- Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- No test substance was detected in the blank buffer solutions.
- Preliminary study:
- At pH 4, <10 % of hydrolysis was observed after 5 day (half-life time at 25 °C is >1 year). No additional testing is required.
At pH 7 and pH 9, >10 % of hydrolysis was observed after 5 days (half-life time at 25 °C is <1 year). The higher Tier test was not performed as it was concluded that for this multi-constituent it is not possible to determine the half-life time more accurate (degradation products are a part of the original test substance). Also, according to the guidelines, the purity of the test substance should be at least 95 % which is not the case for the multi-constituent FAT 40854/A. - Test performance:
- Recovery is the mean concentration analysed at t=0 relative tothe nominal concentration.
- Transformation products:
- not specified
- % Recovery:
- 109
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 0 h
- Remarks on result:
- other: St. dev. not specified
- % Recovery:
- 112
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 0 h
- Remarks on result:
- other: St. dev. not specified
- % Recovery:
- 114
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 0 h
- Remarks on result:
- other: St. dev. not specified
- Remarks on result:
- not measured/tested
- Validity criteria fulfilled:
- yes
- Conclusions:
- At pH 4 (50 °C), 6 % of hydrolysis was observed after 5 days. As this is less than 10 %, the half-life time at 25°C is >1 year. Therefore, FAT 40584/A can be considered hydrolytically stable at pH 4, according to the OECD111 guideline. At pH 7 and pH 9 (50 °C) 19 % and 80 % of hydrolysis was observed after 5 days, respectively.
- Executive summary:
In a GLP-compliant study, a hydrolysis study with FAT 40854/A was carried out according to EU method C.7 and OECD 111. At pH 4 (50 °C), 6 % of hydrolysis was observed after 5 days. As this is less than 10 %, the half-life time at 25 °C is >1 year. Therefore, FAT 40584/A can be considered hydrolytically stable at pH 4 and no additional testing is required. At pH 7 and pH 9 (50 °C), 19 % and 80 % of hydrolysis was observed after 5 days, respectively. As this value is ≥10 %, the half-life time at 25 °C is <1 year. Therefore, FAT 40584/A is considered to be hydrolytically unstable at pH 7 and 9. Nevertheless, the higher Tier test was not performed as it was concluded that for this multi-constituent it is not possible to determine the half-life time more accurate (degradation products are a part of the original test substance). Also, according to the guidelines, the purity of the test substance should be at least 95 % which is not the case for the multi-constituent FAT 40854/A.
Reference
Table Hydrolysis of the test substance at pH 4, pH 7 and pH 9 at 50.0 +/1 °C
pH code |
Sampling time |
Analysed concentration |
Degree of hydrolysis |
Actual pH |
|
Individual |
Mean |
||||
|
|
|
|
|
|
pH 4 |
0 hours |
147 |
|
|
4.0 |
|
|
152 |
|
|
4.0 |
|
|
|
|
|
|
|
5 days |
139 |
6.8 |
6.0 |
4.0 |
|
|
141 |
5.2 |
|
4.0 |
|
|
|
|
|
|
pH 7 |
0 hours |
201 |
|
|
7.0 |
|
|
204 |
|
|
7.0 |
|
|
|
|
|
|
|
5 days |
163 |
19 |
19 |
7.0 |
|
|
164 |
19 |
|
7.0 |
|
|
|
|
|
|
pH 9 |
0 hours |
222 |
|
|
9.0 |
|
|
214 |
|
|
9.0 |
|
|
|
|
|
|
|
5 days |
43.4 |
80 |
80 |
9.0 |
|
|
42.4 |
81 |
|
9.0 |
Description of key information
At pH 4 (50 °C), 6 % of hydrolysis was observed after 5 days. As this is less than 10 %, the half-life time at 25°C is > 1 year. Therefore, FAT 40854/A TE can be considered hydrolytically stable at pH 4, according to the OECD111 guideline.
At pH 7 and pH 9 (50 °C) 19 % and 80 % of hydrolysis was observed after 5 days, respectively.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
In a GLP-compliant study, a hydrolysis study with FAT 40854/A was carried out according to EU method C.7 and OECD 111. At pH 4 (50 °C), 6 % of hydrolysis was observed after 5 days. As this is less than 10 %, the half-life time at 25 °C is >1 year. Therefore, FAT 40584/A can be considered hydrolytically stable at pH 4 and no additional testing is required. At pH 7 and pH 9 (50 °C) 19 % and 80 % of hydrolysis was observed after 5 days. As this rate is ≥10 %, the half-life time at 25 °C is <1 year. Therefore, FAT 40584/A is considered to be hydrolytically unstable at pH 7 and 9. Nevertheless, the higher Tier test was not performed as it was concluded that for this multi-constituent it is not possible to determine the half-life time more accurate (degradation products are a part of the original test substance). Also, according to the guidelines, the purity of the test substance should be at least 95 % which is not the case for the multi-constituent FAT 40854/A.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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