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Diss Factsheets
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EC number: 915-634-1 | 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
- Remarks:
- as a function of pH
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 November 2020- 04 March 2021
- 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)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 20 to 21 November 2018 and 7 June 2019; Date of decision: 21 August 2019
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals/times for pH measurements: 0, 120 and 126 h
- Buffers:
- pH 4: Ready-made concentrate (Titrisol®, MERCK, Darmstadt, Germany, art. No. 9884, citrate/ hydrochloric acid buffer) pH 4.00 ± 0.02 at 20°C,
pH 7: Ready-made concentrate (Titrisol®, MERCK, Darmstadt, Germany, art. No. 9887, phosphate buffer) pH 7.00 ± 0.02 at 20°C,
pH 9: Ready-made concentrate (Titrisol®, MERCK, Darmstadt, Germany, art. No. 9889, boric acid/ potassium chloride/ sodium hydroxide buffer) pH 9.00 ± 0.02 at 20°C,
In order to avoid any unnecessary excess of inorganic salts that could reduce the solubility of the test substance, these buffer solutions were diluted to 10% with ultrapure water before being used as test media. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Hydrolysis reactions are performed in amber glass bottles (repeated sampling from recipient) or 20 ml amber-glass vials (crimp caps with Teflon coated rubber septa, a minimum of two vials is sacrificed for each sampling point). A constant temperature water bath (JULABO MP, JULABO Labortechnik GmbH, Seelbach, Germany) is used to maintain to ±0.1 °C the test vessel temperature.
- Sterilisation method: None - Duration:
- 0 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 71.91 mg/L
- Remarks:
- Ethyl Safranate is considered hydrolytically stable.
- Duration:
- 0 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 74.24 mg/L
- Remarks:
- Ethyl Safranate is considered hydrolytically stable.
- Duration:
- 0 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 73.88 mg/L
- Remarks:
- Ethyl Safranate is considered hydrolytically stable.
- Number of replicates:
- 2
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The preliminary test (Tier 1) was performed at 50°C and at pH 4, pH 7 and pH 9. The obtained hydrolysis values were 0.82%, 7.12% and 10.54% respectively.
- Transformation products:
- not specified
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- >= 1 yr
- Type:
- not specified
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Validity criteria fulfilled:
- yes
- Conclusions:
- The half-life time of test item at 25°C is higher than one year at pH 4 and pH 7, while at pH 9 the hydrolysis of test item corresponds to a value of approximately 1 year at 25°C according to the OECD Guideline n° 111.
- Executive summary:
An abiotic degradation study (hydrolysis as a function of pH) was carried out with test item according to OECD guideline 111. The preliminary test (Tier 1) was performed at 50°C and at pH 4, pH 7 and pH 9. The obtained hydrolysis values were 0.82%, 7.12% and 10.54% respectively.
At pH 4 and pH 7, test item is considered hydrolytically stable since, less than 10% hydrolysis occurred after 120 h, which corresponds to a half-life of more than one year at 25°C according to the OECD Guideline n° 111. Therefore, no additional testing is required at pH4 and pH 7.
At pH 9 the observed hydrolysis in the preliminary test was slightly higher than 10%. However, it was decided not to pursue with the Tier 2 test given that the observed value of 10.54% after 120 h would not represent significant hydrolysis potential or a significant change in the half-life of the substance which was estimated to be approximately 30 days at 50 °C, equivalent to approximately 1 year at 25°C according to the OECD Guideline 111.
Therefore, the half-life time of test item at 25°C is higher than one year at pH 4 and pH 7, while at pH 9 the hydrolysis of test item corresponds to a value of approximately one year at 25°C according to the OECD Guideline 111.
Reference
Table 5.1.2/1. Percentage decrease of test item after 120 h and 126 h of hydrolysis at pH 4, 7 and 9
pH |
Percentage decrease of test item |
pH 4 at 120h |
0.82 |
pH 7 at 120h |
7.13 |
pH 9 b t 120h |
10.54 |
pH 4 at 126h |
2.23 |
pH 7 at 126h |
3.66 |
pH 9 at 126h |
28.00 |
At pH 4 and pH 7, test item is considered hydrolytically stable since, less than 10% hydrolysis occurred after 120 h, which corresponds to a half-life of more than one year at 25°C according to the OECD Guideline 111. Therefore, no additional testing is required at pH4 and pH 7.
At pH 9 the observed hydrolysis in the preliminary test was slightly higher than 10%. However, it was decided not to pursue with the Tier 2 test given that the observed value of 10.54% after 120 h would not represent significant hydrolysis potential or a significant change in the half-life of the substance which was estimated to be approximately 30 days at 50 °C, equivalent to approximately 1 year at 25°C according to the OECD Guideline 111.
Description of key information
An abiotic degradation study (hydrolysis as a function of pH) was carried out with test item according to OECD guideline 111. The preliminary test (Tier 1) was performed at 50°C and at pH 4, pH 7 and pH 9. The obtained hydrolysis values were 0.82%, 7.12% and 10.54% respectively.
At pH 4 and pH 7, test item is considered hydrolytically stable since, less than 10% hydrolysis occurred after 120 h, which corresponds to a half-life of more than one year at 25°C according to the OECD Guideline n° 111. Therefore, no additional testing is required at pH4 and pH 7.
At pH 9 the observed hydrolysis in the preliminary test was slightly higher than 10%. However, it was decided not to pursue with the Tier 2 test given that the observed value of 10.54% after 120 h would not represent significant hydrolysis potential or a significant change in the half-life of the substance which was estimated to be approximately 30 days at 50 °C, equivalent to approximately 1 year at 25°C according to the OECD Guideline 111.
Therefore, the half-life time of test item at 25°C is higher than one year at pH 4 and pH 7, while at pH 9 the hydrolysis of test item corresponds to a value of approximately one year at 25°C according to the OECD Guideline 111.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
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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