Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-090-3 | CAS number: 51-34-3
- 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:
- 2015-09-04 to 2015-10-14
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Solvent for sample stabilization: acidified acetonitrile (1% H3PO4 v/v)- At each sampling time 2.0 mL acetonitrile acidified with 1 % phosphoric acid were added to the sample with a Hamilton syringe (dilution factor = 2) and the sample was homogenized.- Sampling time: Tier 1 Test: at the beginning, after 2.4 hours and after 120 hours; Tier 2 Test: pH 7 at 20°C: 0, 48, 166, 268, 433, 602, 720 hours, pH 9 at 20°C: 0, 48, 95, 166, 268, 337, 433, 602 hours, pH 7 at 35°C: 0, 48, 166, 268, 337, 433, 602, 720 hours, pH 9 at 35°C: 0, 28, 48, 69, 95, 166, 214 hours, pH 7 at 50°C: 0, 44, 69, 95, 166, 214, 337 hours, pH 9 at 50°C: 0, 4, 20, 28, 44, 48, 53, 69 hours
- Buffers:
- - Type and final molarity of buffer: citrate buffer (pH 4), phosphate buffer (pH 7) and borate buffer (pH 9); concentration of each 0.05 M
- Composition of buffer:
Citrate buffer: 10.519 g citric acid monohydrate were dissolved in 500 mL deionised water. 59 mL of the sodium hydroxide (1M) solution was added and the flask was brought to a total volume of 1 L with deionised water. The pH value of the buffer solution was determined to be 4.00.
Phosphate buffer: 6.810 g Potassium dihydrogenphosphate were dissolved in 500 mL deionised water. 30 mL of the sodium hydroxide (1M) solution was added and the flask was brought to a total volume of 1 L with deionised water.
Borate buffer: 3.747 g potassium chloride and 3.098 g boric acid were dissolved in 500 mL deionised water. 20 mL of the sodium hydroxide (1M) solution was added and the flask was brought to a total volume of 1 L with deionised water. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: normal laboratory glassware and instrumentation; 100 mL (250 mL for Tier 2) volumetric flask; 6 mL glass vials; pH meter (WTW Germany); Water bath; Min.-max.-thermometer and data logger; Climate cabinet, Mass balance; Flat bed shaker
- Measures taken to avoid photolytic effects: photolytic interference was avoided; method not specified
- Measures to exclude oxygen: degassing the buffers with argon for at least five minutes and purging the vessels with argon before preparing the test solution.
- If no traps were used, is the test system closed
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no - Number of replicates:
- - Tier 2 Test: Individual replicate test samples (a minimum of duplicate samples contained in separate reaction vessels) were removed and the contents were analysed at each of at least six sampling times (for a minimum of twelve replicate data points).
- Positive controls:
- no
- Negative controls:
- no
- Transformation products:
- not specified
- Key result
- pH:
- 7
- Temp.:
- 20 °C
- DT50:
- 163 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 20 °C
- DT50:
- 14 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 35 °C
- DT50:
- 33.3 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 35 °C
- DT50:
- 3.4 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- 7.58 d
- Type:
- (pseudo-)first order (= half-life)
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- 0.96 d
- Type:
- (pseudo-)first order (= half-life)
- Validity criteria fulfilled:
- yes
- Conclusions:
- The half-life time at pH 4 can be estimated to be longer than one year at 25°C. For pH 7 and pH 9 a half-life of 163 and 14 days at 20°C was determined, respectively.
Reference
Tier 1 Test:
The hydrolysis of the test item was negligible at pH 4. The degradation of Scopolamine was less than 10% at pH 4 at 50°C over a period of 120 hours. Therefore the corresponding half-life time at pH 4 can be estimated to be longer than one year at 25°C.
The hydrolysis of the test item was more than 10% at pH 7 and pH 9 at 50°C over a period of 120 hours. Based on this results a Tier 2 test at 20°C, 35°C and 50°C was performed at pH 7 and pH 9.
Table 1: Summarized degradation half-life values (Tier 2 Test)
Test-temperature |
pH value |
Kinetic model |
Slope a [h^-1] |
Y-axis intercept b |
DT50 [h] |
DT50 [d] |
20°C |
pH 7 |
SFO |
-7.85 x 10^-5 |
6.50 x 10^-3 |
3918 |
163 |
pH 9 |
SFO |
-9.05 x 10^-4 |
6.10 x 10^-3 |
339 |
14 |
|
35°C |
pH 7 |
SFO |
-3.83 x 10^-4 |
4.44 x 10^-3 |
798 |
33.3 |
pH 9 |
SFO |
-3.73 x 10^-3 |
3.07 x 10^-4 |
81 |
3.4 |
|
50°C |
pH 7 |
SFO |
-1.67 x 10^-3 |
2.28 x 10^-3 |
182 |
7.58 |
pH 9 |
SFO |
-1.32 x 10^-2 |
2.01 x 10^-3 |
23 |
0.96 |
SFO = Single First Order
Description of key information
The hydrolysis of the test item was negligible at pH 4. The degradation of Scopolamine was less than 10% at pH 4 at 50°C over a period of 120 hours. Therefore the corresponding half-life time at pH 4 can be estimated to be longer than one year at 25°C.
At 35°C a half-life of 33.3 days for pH 7 and 3.4 days for pH 9 were determined. At 50°C a half-life of 7.58 days for pH 7 and 0.96 days for pH 9 were determined.
At 20 °C, half-lives of 163 days at pH 7 and 14 days at pH 9 were determined.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 163 d
- at the temperature of:
- 20 °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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.