Registration Dossier
Registration Dossier
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: 260-828-5 | CAS number: 57583-34-3
- 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:
- 16 January 2015 to 03 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- no
- Analytical monitoring:
- yes
- Buffers:
- The buffer systems were selected according to the guidelines. The chosen buffers provided the required pH values. Commercially available solutions were used:
pH 1.2: HCl 0.1 M
pH 4.0: HCl / NaCl / Citric acid
pH 7.0: Na2HPO4 / NaH2PO4
pH 9: H3BO3 / KCl / NaOH - Details on test conditions:
- High pH testing (pH 4.0, 7.0 and 9.0)
The test material was used without a co-solvent or a detergent.
1 g (1.3 mMol) of the test material was added to 100 mL of the respective buffer solution in a 250 mL Erlenmeyer flask. The flask was closed with a stopper and heated in a heating cabinet for 5 days (120 h) at 50 °C. The mixture was stirred by a magnetic stirrer using a 40*7, stir bar at approx. 100 rpm. The test was carried out at pH 1.2 and 37 °C.
After the pre-determined reaction time, the reaction mixture was allowed to cool down to room temperature and extracted with hexane. The phases were separated using a separatory funnel. The organic phase was transferred to a pre-weighed flask and the solvent was removed in a rotary evaporator (< 40 °C, 10 mbar). The weight difference was recorded for the mass balance and the samples were analysed by 119Sn-NMR.
The water phase was analysed by AAS for a total tin content.
Gastric pH testing (pH 1.2 / 37 °C)
The test material was used without a co-solvent or a detergent.
1 g (1.3 mMol) test material was added to 100 mL of 0.1 < aqueous solution of hydrochloric acid that was pre-heated to 37 °C in a 250 mL Erlenmeyer flask with ground.
The flask was closed with a stopper and heated on a heating cabinet for 4 h at 37 °C. The mixture was stirred by a magnetic stirrer using a 40 x 7 mm stir bar at approximately 100 rpm.
After the pre-determined exposure time, the solution was allowed to cool down to room temperature; extracted 2 times with 25 mL hexane; the phases were separated using a separatory funnel. The organic phase was transferred into a flask, and the solvent was removed in a rotary evaporator (< 40 °C, 10 mbar). The sample was analysed by 119Sn-NMR spectroscopy. - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.3 mmol/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.3 mmol/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 1.3 mmol/L
- Duration:
- 4 h
- pH:
- 1.2
- Temp.:
- 37 °C
- Initial conc. measured:
- 1.3 mmol/L
- Remarks:
- Gastric pH testing
- Number of replicates:
- Not specified
- Positive controls:
- no
- Negative controls:
- no
- Transformation products:
- yes
- No.:
- #1
- Details on hydrolysis and appearance of transformation product(s):
- Hydrolysis at pH 4.0, 7.0 and 9.0: samples of the test material were added to the respective buffer solutions at 50 °C for 5 days (120 h). The reaction products were extracted with hexane. The 119Sn-NMR spectra of the extracted reaction products did not show any sign of hydrolysis.
Hydrolysis at pH 1.2: A sample of the test material was added to an excess of a 0.1 M hydrochloric acid at 37 °C for 4 h. The 119Sn-NMR spectrum of the recovered reaction product showed that the test material is partially hydrolysed to MMTEC. Both substances were present in equilibrium in a ca. 70/30 MMTE / MMTEC mol % ratio.
MMTEC a product of hydrolysis, has been identified based on the 119Sn-NMR signal at -12.7 ppm. The substance was already present in the non-treated test material as an impurity of ca. 4 % (NMR).
No signal corresponding to MMTC (typically present at 133 ppm) was detected. - pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Remarks on result:
- other: St. dev. not reported.
- Details on results:
- Mass balance: For each tested pH value, a 1 g (1.3 mmol) sample of the test material was added to the respective buffer solution. After the required hydrolysis period of 5 days amounts of the hydrolysate were recovered via hexane extraction from the aqueous phase.
The mass balance showed a high recovery of the initial material of the test material after completing the hydrolysis test over the required period (5 days) and the extraction with hexane. It demonstrates high reliability of the chosen experimental design of the study.
The aqueous phases of the hydrolyses at different pH values have been analysed for tin content by AAS.
Tin content in remaining aqueous phases:
pH 4: 280 mg tin/L.
pH 7: 70 mg tin/L.
pH 9: 115 mg tin/L.
This shows that water soluble tin compounds were only present in trace amounts in the reaction mixture after the hydrolysis test followed by the extraction with hexane. - Validity criteria fulfilled:
- not specified
- Conclusions:
- Under the conditions of the study the test material at pH 4, 7 and 9 can be considered hydrolytically stable. After 5 days at 50 °C less than 10 % of the test material was hydrolysed (t0.5 25°C > 1 year).
Under simulated gastric conditions (0.1 M HCl / pH 1.2 / 37 °C) the test material was partially hydrolysed to its monochloro ester.
It can be concluded that the monochloro ester is the only metabolite of the test material that was formed in the simulated mammalian gastric environment. - Executive summary:
The hydrolysis of the test material was assessed according to OECD Test Guideline 111 and EU Method C.7. Quantitative ^119Sn-NMR spectroscopy has been used as a valuable analytical tool to directly identify and quantify all organotin components, which are formed as a result of hydrolysis of the tested substance.
The study shows that the test material at pH 4, 7 and 9 can be considered hydrolytically stable. After 5 days at 50 °C less than 10 % of the test material was hydrolysed (t0.5 25°C > 1 year).
Under the simulated gastric conditions (0.1 M HCl / pH 1.2 / 37 °C) the test material was partially hydrolysed to its monochloro ester.
It can be concluded that the monochloro ester is the only metabolite of the test material that was formed in the simulated mammalian gastric environment. No MMTC was formed under the conditions of the study.
Reference
Composition of test material lysate in the pH 1.2 buffer based on 119Sn-NMR analysis
pH value |
MMTE [Mol%] |
MMTEC [Mol%] |
MMTE:MMTCE ratio |
Start |
96 |
4 |
96:4 |
pH 1.2 |
69 |
31 |
69:31 |
NMR ppm |
6807 |
-12.7 |
|
Recovery of the tested material
pH |
Initial mass [g] |
Recovered [g] |
Recovery rate [%] |
4 |
1.0 |
0.89 |
89 |
7 |
1.0 |
0.97 |
97 |
9 |
1.0 |
0.89 |
89 |
Description of key information
Under the conditions of the study the test material at pH 4, 7 and 9 can be considered hydrolytically stable. After 5 days at 50 °C less than 10 % of the test material was hydrolysed (t0.5 25°C > 1 year).
Under simulated gastric conditions (0.1 M HCl / pH 1.2 / 37 °C) the test material was partially hydrolysed to its monochloro ester.
It can be concluded that the monochloro ester is the only metabolite of the test material that was formed in the simulated mammalian gastric environment.
Key value for chemical safety assessment
Additional information
The hydrolysis of the test material was assessed according to OECD Test Guideline 111 and EU Method C.7. Quantitative ^119Sn-NMR spectroscopy has been used as a valuable analytical tool to directly identify and quantify all organotin components, which are formed as a result of hydrolysis of the tested substance.
The study shows that the test material at pH 4, 7 and 9 can be considered hydrolytically stable. After 5 days at 50 °C less than 10 % of the test material was hydrolysed (t0.5 25°C > 1 year).
Under the simulated gastric conditions (0.1 M HCl / pH 1.2 / 37 °C) the test material was partially hydrolysed to its monochloro ester.
It can be concluded that the monochloro ester is the only metabolite of the test material that was formed in the simulated mammalian gastric environment. No MMTC was formed under the conditions of the study.
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.

EU Privacy Disclaimer
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.