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Diss Factsheets
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EC number: 200-023-8 | CAS number: 50-28-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Environmental Assessment Technical Assistance Handbook (US Food and Drug Administration, FDA, 1987), Technical Assistance Documents-Environmental Fate Testing (TAD), no. 3.09
- Deviations:
- yes
- Remarks:
- According to FDA-TAD no. 3.09, triplicate samples are to be analyzed at each sampling time. After 5 days only duplicate samples were analyzed.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- SAMPLING SCHEDULE:
- Day 0: The test concentration was measured in triplicate on the stock solutions of pH 5, 7 and 9
- Day 5: The test concentration was measured in duplicate on the stock solutions of pH 5, 7 and 9 - Buffers:
- I. Buffer solution pH 5:
- 0. 0158 M acetate buffer solution pH 5: 0.82 g sodium acetate (Merck Art. 106268; MG 82.03 g/mol) were dissolved to 1000 ml with double distilled water; the pH value was adjusted to 5 by adding acetic acid (100%; Merck Art. 100063)
II. Buffer solution pH 7:
- 0.0067 M phosphate buffer solution pH 7: 0.584 g disodium hydrogen phosphate (Merck Art. 106566; (MG 141 .96 g/mol) and 0.354 g potassium dihydrogen phosphate (Merck Art. 105108; MG 136.09 g/mol) were dissolved to 1000 ml with double distilled water; the pH value was adjusted to 7 by
adding phosphoric acid 10 %
III. Buffer solution pH 9
- 0. 1 M borate buffer solution pH 9: 5.03 g disodium tetraborate (Merck Art. 1 06309) and 92ml hydrochloric acid (Titrisol Merck Art. 109973, 0.1 M)
were dissolved to 1000 ml with double distilled water; the pH value was adjusted to 9.20 by adding 1 M sodium hydroxide solution (Titrisol Merck Art. 109959) in order to take into account the temperature dependence of the pH of this buffer solution - Details on test conditions:
- EXPERIMENTAL DESIGN:
I. Preparation of test solution:
- Three stock solutions, buffered to pH values of 5, 7 and 9, each with a test concentration of approx. 1 mg/1 buffer solution containing 1 % acetonitrile, were prepared using sterilized equipment, buffer solutions and double distilled water
II. Procedures for incubation and sampling:
- Aliquots of the test solutions were filled into sterilized 5 mL autosampler vials which were tightly closed with screw caps
- The vials were incubated in a thermostatic water bath at 50± 0.1 °C
- After a hydrolysis time of approx. 5 days two vials from each of the hydrolysis solutions at pH 5, 7 and 9 were removed from the thermostatic bath and analyzed
- The pH values of the test solutions were measured in a separate vessel at the test temperature of 50 °C at the start and at the end of incubation
- During the hydrolysis experiment possible photolytic degradation of the test substance was prevented by exclusion of light from the hydrolysis solutions by using a thermostatic bath made of stainless steel with a metal cover
III. Apparatus:
- Analytical balance MC 210 P-OCE (Sartorius)
- Thermostatic bath DC 3 I W 19 (Haake)
- Pt 100 resistance thermometer (Knick), graded by a calibrated thermometer, connected to digital pH meter 647 (Knick) with recorder 1100 (W+W) for registration of temperature
- pH meter 766 (Knick) with calibrated glass electrode 00554106 (Metrohm)
- HPLC system - Duration:
- 5 d
- pH:
- 5
- Temp.:
- 50
- Initial conc. measured:
- 0.977 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50
- Initial conc. measured:
- 0.971 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50
- Initial conc. measured:
- 0.974 mg/L
- Transformation products:
- no
- % Recovery:
- 97.7
- pH:
- 5
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 97.5
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 5 d
- % Recovery:
- 95
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 5 d
- pH:
- 5
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: estimated (see "Details for result")
- Key result
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: estimated (see "Details for result")
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: estimated (see "Details for result")
- Details on results:
- The data indicate that less than 10 % of the test substance are hydrolyzed at 50 °C within 5 days of observation at pH 5, 7 and 9. Therefore the substance can be considered hydrolytically stable, i.e. ty, > 1 year at 25 °C and no further testing is required.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No hydrolytic degradation was observed within 5 days at pH 5, 7 and 9 at 50 ± 0.1 °C (pretest). Therefore no further testing was required and estradiol can be considered to be hydrolytically stable at pH 5, 7 and 9 and 25 °C, i.e. t1/2 > 1 year.
- Executive summary:
The rate of hydrolysis in aqueous solutions buffered to pH values of 5, 7 and 9 was studied in a preliminary test according to FDA Technical Asisstance Documents-Environmental Fate Testing (TAD), No. 3.09 in agreement with EU testing guideline C.7. No hydrolytic degradation was observed within 5 days at pH 5, 7 and 9 at 50 ± 0.1 °C (pretest). Therefore no further testing was required and estradiol can be considered to be hydrolytically stable at pH 5, 7 and 9 and 25 °C, i.e. t1/2> 1 year.
Reference
The acid dissociation constant of estradiol is 10. 71 (Lewis, K. M., Archer, R. D.; Steroids, 34, 5, p. 485-499 (1979)).
Description of key information
The substance is hydrolytically stable at pH 5, pH7 and pH9 (25°C).
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
"Should read: > 1 year at 25 °C"
No hydrolytic degradation was observed within 5 days at pH 5, 7 and 9 at 50 ± 0.1 °C (pretest). Therefore no further testing was required and the substance can be considered to be hydrolytically stable at pH 5, 7 and 9 and 25 °C.
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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