Registration Dossier
Registration Dossier
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EC number: 247-666-0 | CAS number: 26401-97-8
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across to structurally similar substance Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 22 January 2016 to 05 April 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- (non-GLP)
- Reason / purpose for cross-reference:
- other: read-across target
- Objective of study:
- metabolism
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 111
- GLP compliance:
- no
- Radiolabelling:
- no
- Conclusions:
- The study showed that DOTE at pH 9, 7 and 4 can be considered hydrolytically stable. After 5 days at 50°C less than 10% DOTE was hydrolysed (t 0.5 25°C > 1 year).
Under the simulated gastric conditions (0.1 M HCl / pH 1.2 / 37 °C) DOTE was hydrolysed to DOTEC, its monochloride ester.
It can be concluded that DOTEC is the only metabolite of DOTE that was formed in the simulated mammalian gastric environment. No DOTC was formed under the conditions of this study. - Executive summary:
The study showed that DOTE at pH 9, 7 and 4 can be considered hydrolytically stable. After 5 days at 50 °C less than 10% DOTE was hydrolysed (t 0.5 25°C > 1 year).
Under the simulated gastric conditions (0.1 M HCl / pH 1.2 / 37 °C) DOTE was hydrolysed to DOTEC, its monochloride ester.
It can be concluded that DOTEC is the only metabolite of DOTE that was formed in the simulated mammalian gastric environment. No DOTC was formed under the conditions of this study.
Data source
Materials and methods
Test material
- Reference substance name:
- Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate
- EC Number:
- 247-666-0
- EC Name:
- Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate
- Cas Number:
- 26401-97-8
- Molecular formula:
- C36-H72-O4-S2-Sn
- IUPAC Name:
- 6-methylheptyl 14-methyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannapentadecan-1-oate
Constituent 1
Results and discussion
Any other information on results incl. tables
The study showed that DOTE at pH 9, 7 and 4 can be considered hydrolytically stable. After 5 days at 50 °C less than 10% DOTE was hydrolysed (t 0.5 25 °C > 1 year).
Under the simulated gastric conditions (0.1 M HCl / pH 1.2 / 37 °C) DOTE was hydrolysed to DOTEC, its monochloride ester.
It can be concluded that DOTEC is the only metabolite of DOTE that was formed in the simulated mammalian gastric environment. No DOTC was formed under the conditions of this study.
Applicant's summary and conclusion
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