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EC number: 201-210-7 | CAS number: 79-50-5
- 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24/06/1999 - 29/06/1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed under GLP according to the Guideline
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Statement of compliance
Test material
- Reference substance name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- EC Number:
- 201-210-7
- EC Name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- Cas Number:
- 79-50-5
- Molecular formula:
- C6H10O3
- IUPAC Name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- Details on test material:
- - Name of test material (as cited in study report): DL-Lactone
- Physical state: white cristalline mass
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not relevant - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- To prepare DL-LACTONE stock solutions, scrapings of the white crystalline mass were
accurately weighed into suitable volumetric flasks and thereafter dissolved in Milli-Q water. In
order to dissolve the test substance completely, the solutions were sonicated for 5 minutes
On each day of analysis, two calibration solutions in mobile phase were made up from two stock
solutions (0.72 g/l and 1.3 g/l). As internal standard, 4-hydroxy-6-methyl-2-pyrone was added to
a final concentration of 2.04 mg/l. 2 ml samples were taken and cooled to room temperature. - Buffers:
- A sterile 0.05 M acetate buffer pH 4: sodium acetatelacetic acid/Milli-Q water.
A sterile 0.05 M phosphate buffer pH 7: potassium dihydrogen phosphate/ sodium hydroxide1Milli-Q water.
A sterile 0.05 M borate buffer pH 9: boric acid/potassium chloride/sodium hydroxidelMilli-Q water.
A sterile 0.5 M borate buffer pH 9: boric acid/potassium chloride/sodium hydroxide1Milli-Q water. - Estimation method (if used):
- Not used.
- Details on test conditions:
- Preparation of the test solutions:
Scrapings of the white crystalline test substance mass were used to prepare DL-LACTONE
solutions. An accurately weighed amount between 63 and 66 mg test substance was added to 50.0 ml
buffer solution pH 4, pH 7 and pH 9 (0.05 M and 0.5 M). After sonication for 5 minutes, the
resultant solutions were filter-sterilized through a 0.2 pm membrane filter and transferred into sterile glass vessels.
To exclude oxygen, nitrogen gas was bubbled through each solution for 5 minutes. Thereafter, each vessel was
tightly sealed with a septum-crimpcap.
Test procedure (preliminary test according to EEC Guideline C.7.):
After preparation, the test solutions at pH 4, pH 7 and pH 9 (0.05 M and 0.5 M) were placed in a
thermostatically controlled waterbath at 50.0 2 0.5"C in the dark. The concentration of the test
substance was determined immediately after preparation (t=O), after 2.4 hours and after 5 days.
pH measurements:
For each test solution, the pH value at room temperature was determined for each sample taken.
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50
- Initial conc. measured:
- 1 361 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50
- Initial conc. measured:
- 1 202 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50
- Initial conc. measured:
- 81.4 mg/L
- Number of replicates:
- One incubation per pH point.
Concentration measurements: duplicate analysis - Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- blank buffers
- Statistical methods:
- Mean values of duplicate analysis.
Results and discussion
- Preliminary study:
- Only preliminary study was performed
- Test performance:
- Not relevant
- Transformation products:
- not measured
- Details on hydrolysis and appearance of transformation product(s):
- Not relevant
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 1 d
- Type:
- not specified
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- > 1 d
- Type:
- not specified
- Other kinetic parameters:
- Not relevant
- Details on results:
- The nominal concentration was 1300 mg/l and 1306 mg/l for the pH 9 (0.05 M) solution and the
pH 9 (0.5 M) solution, respectively. Relative to nominal concentrations of 26% and 6% were
analyzed at t=O for these solutions. Possibly D,L-LACTONE transforms at pH > 8 or the
solubility of D,L-LACTONE is significantly lower at pH >8.
At pH 4, a decrease in concentration <10% was observed after 5 days. Hence it was concluded
that D,L-LACTONE is hydrolytically stable at pH 4 (half-life time at 25°C > 1 year), under the
conditions of the test.
At pH 7 and pH 9, a decrease in concentration < 50% after 2.4 hours but > 10% after 5 days
was observed. Hence it was concluded that at both pH 7 and pH 9, the half-life time at 25°C is
between 1 day and 1 year, under the conditions of the test.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- For pH 4, the half-life at 25°C of DL-Lactone is > 1 year; for pH 7, and 9 between 1 day and 1 year.
- Executive summary:
The determination of the hydrolysis 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".
DL-LACTONE was determined to be hydrolytically stable at pH 4 (half-life time at 25°C > 1
year), under the conditions of the test.
At both pH 7 and pH 9, the half-life time at 25°C was determined to be between 1 day and
1 year.
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