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EC number: 442-480-8 | CAS number: 182893-11-4
- 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:
- 26 June 2002 - 16 August 2002
- 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)
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: peliminary test: 0h, 2.4h and 5 days.
- Sampling method:No data
- Sampling methods for the volatile compounds, if any: NA
- Sampling intervals/times for pH measurements: For each test solution, the pH value at room temperature was determined at the beginning and
at the end of each test.
- Sampling intervals/times for sterility check:NA
- Sample storage conditions before analysis: The samples taken at t>0 were cooled to room temperature by running tap-water immediately after sampling. Thereafter, each sample was diluted with acetonitrile in a 1:1 ratio to obtain concentrations within the calibration range and analysed.
- Other observation, if any (e.g.: precipitation, color change etc.): None - Buffers:
- A sterile 0.05 M acetate buffer pH 4: sodium acetate/acetic acid/Milli-Q water.
A sterile 0.05 M phosphate buffer pH 7: potassium dihydrogen phosphate/ sodium hydroxide/Milli-Q water.
A sterile 0.05 M borate buffer pH 9: boric acid/potassium chloride/sodium hydroxide/Milli-Q water. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: EC C.7
- Sterilisation method: Prior to the start of each test, the test solutions were freshly prepared. For the preparation of the test solutions, 50 ml of each buffer solution (pH 4, pH 7 or pH 9) was filter-sterilised through a 0.2 µm membrane filter (FP 30/0.2 CA-S, Schleicher & Schuell, Dassel, Germany) and transferred into sterile glass vessels.
- Lighting: in the dark
- Measures taken to avoid photolytic effects:
- Measures to exclude oxygen: To exclude oxygen, nitrogen gas was bubbled through each solution for 5 minutes. Each vessel was tightly sealed with a septum-crimpcap.
TEST MEDIUM
- Volume used/treatment: 500 µl of a 23.6 g/l solution of the test substance in acetonitrile was added to each of the sterile buffer solutions.
- Kind and purity of water: MilliQ
- Preparation of test medium: see above
- Renewal of test solution: none
- Identity and concentration of co-solvent: acetonitrile - Number of replicates:
- single samples, duplicate analysis
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- None
- Preliminary study:
- MIPK is a degradation product of the other compounds present in the formulation. Therefore it was not possible to determine the hydrolysis of this component.
At pH 9 for MIPKP-T4, a decrease in concentration < 10% was observed after 5 days (half-life time at 25°C> 1 year). Therefore, no further testing was necessary at pH 9 for MIPKP-T4.
At pH 4 (for MIPKP-T3 and MIPKP-T4), pH 7 (for MIPKP-T3 and MIPKP-T4) and pH 9 (for MIPKP-T3), a decrease in concentration < 50% after 2.4 hours but> 10% after 5 days was observed. In order to determine if hydrolysis of MIPKP is a pseudo-first order reaction and to determine the half-life time at 25°C, subsequent tests were performed at these pH values and for these compounds. - Test performance:
- The analytical results of the subsequent hydrolysis tests are summarised in the attached Tables. No test substance was measured in the blank buffer solutions.
- Transformation products:
- not measured
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- 411 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T4
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- 7 943 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T4
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- 145 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T3 peak 1
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- 1 438 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T3 peak 1
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- 147 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T3 peak 1
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- 98.8 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T3 peak 2
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- 1 221 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T3 peak 2
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- 61.1 h
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: for MIPKP-T3 peak 2
- Other kinetic parameters:
- Testing of pseudo-first order kinetics
For the test solutions at pH 4 (for MIPKP-T3 and MIPKP-T4), pH 7 (for MIPKP-T3 and MIPKP-T4) and pH 9 (for MIPKP-T3), the plots of the logarithms of the relative concentrations between 80% and 30% (i.e. between 20% and 70% hydrolysis) against time were straight lines. Therefore, the reactions at pH 4, pH 7 and pH 9 are considered to be (pseudo)-first order. Hence, the half-life times at 25°C were estimated in a subsequent test.
Determination of the half life at 25 °C
The logarithms of all relative concentrations were plotted against time and a linear regression program (least-squares method) was used to calculate the regression line, see attached tables.
The half-life time for MIPKP-T4 at 25°C is 411 and 7943 hours in aqueous solutions buffered at pH 4 and pH 7 respectively.
The half-life time for MIPKP-T3 peak 1 at 25°C is 145, 1438 and 147 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively.
The half-life time for MIPKP-T3 peak 2 at 25°C is 98.8, 1221 and 61.1 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively. - Details on results:
- See attached Tables.
- Validity criteria fulfilled:
- yes
- Conclusions:
- MIPKP-T4 is hydrolytically stable (half-life time at 25°C> 1 year) in aqueous solutions buffered at pH 9.
The half-life time for MIPKP-T4 at 25°C is 411 and 7943 hours in aqueous solutions buffered at pH 4 and pH 7 respectively.
The half-life time for MIPKP-T3 peak 1 at 25°C is 145, 1438 and 147 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively.
The half-life time for MIPKP-T3 peak 2 at 25°C is 98.8, 1221 and 61.1 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively. - Executive summary:
The determination of the hydrolysis rate of the test substance as a function of pH was based on the EEC-Directive 92/69 EEC, Part C, Methods for the determination of Ecotoxicity, C.7: "Abiotic degradation: Hydrolysis as a function of pH", EEC Publication no. L383, December 1992.
According to information supplied by the sponsor, the substance is a formulation containing several components (see the certificate of analysis). Measurements were performed on the following components: MIPK, MIPKP-T4 and MIPKP-T3 (peak 1 and peak 2). Due to the fact that DMP, which was used for preparation of this formulation, is a very well known compound, which cannot be determined in the same chromatographic run as the other compounds due to a large difference in sensitivity (see also Notox Project 338805 "Development and validation of an analytical method for Trigonox R-938"), analyses were not based on this compound. Due to an interfering peak in blank buffer solutions at the retention time of Hydrogen peroxide it was not possible to determine the hydrolysis of this component. Hydrogen peroxide is a very well known compound and therefore this was not considered to have an effect on this study.
MIPK is a degradation product of the other compounds present in the formulation. Therefore it was not possible to determine the hydrolysis of this component.
MIPKP-T4 is hydrolytically stable (half-life time at 25°C> 1 year) in aqueous solutions buffered at pH 9.
The half-life time for MIPKP-T4 at 25°C is 411 and 7943 hours in aqueous solutions buffered at pH 4 and pH 7 respectively.
The half-life time for MIPKP-T3 peak 1 at 25°C is 145, 1438 and 147 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively.
The half-life time for MIPKP-T3 peak 2 at 25°C is 98.8, 1221 and 61.1 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively.
Reference
Description of key information
MIPKP-T4 is hydrolytically stable (half-life time at 25°C> 1 year) in aqueous solutions buffered at pH 9.
The half-life time for MIPKP-T4 at 25°C is 411 and 7943 hours in aqueous solutions buffered at pH 4 and pH 7 respectively.
The half-life time for MIPKP-T3 peak 1 at 25°C is 145, 1438 and 147 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively.
The half-life time for MIPKP-T3 peak 2 at 25°C is 98.8, 1221 and 61.1 hours in aqueous solutions buffered at pH 4, pH 7 and pH 9 respectively.
Key value for chemical safety assessment
Additional information
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