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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 239-581-2 | CAS number: 15535-79-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 December 2012 to 27 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2,2-dioctyl-1,3,2-oxathiastannolan-5-one
- EC Number:
- 239-581-2
- EC Name:
- 2,2-dioctyl-1,3,2-oxathiastannolan-5-one
- Cas Number:
- 15535-79-2
- Molecular formula:
- C18H36O2SSn
- IUPAC Name:
- 2,2-dioctyl-1,3,2-oxathiastannolan-5-one
- Test material form:
- other: solid (unspecified)
- Details on test material:
- - Appearance: pale brown solid
- Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 12 weeks.
- Weight at study initiation: 160 - 175 g. The bodyweight variation did not exceed ± 20 % of the initial bodyweights.
- Fasting period before study: yes (animals were fasted overnight immediately before dosing and for approximately three to four hours after dosing).
- Housing: animals were housed in groups up to four in suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet: provided ad libitum.
- Water: mains drinking water, ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- PREPARATION OF DOSING FORMULATIONS
The test material was freeze dried using liquid nitrogen, ground to a powder and then freshly prepared, as required, as a solution in dimethyl sulphoxide DMSO. To aid preparation, the formulation was warmed in a water bath at 85 °C for 1 hour. The formulation was allowed to cool before dosing. DMSO was used because the test material did not dissolve/suitably suspend in distilled water/arachis oil BP.
The test material was formulated within 2 hours of being applied to the test system.
VEHICLE
- Concentration in vehicle: 200 mg/mL (2000 mg/kg dose); 30 mg/mL (300 mg/kg dose).
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. - Doses:
- 2000 mg/kg bw (sighting test)
300 mg/kg bw (main test) - No. of animals per sex per dose:
- 1 (sighting test)
5 (main test) - Control animals:
- no
- Details on study design:
- - Study schedule: a single animal was dosed at 2000 mg/kg. Due to mortality at this dose level, an additional group of animals was treated at 300 mg/kg. Treatment of the animals was sequential; sufficient time was allowed between each dose level to confirm survival of the previously dosed animals.
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical observations were made ½, 1, 2 and 4 hours after dosing and then daily thereafter. Morbidity and mortality checks were made twice daily.
- Frequency of weighing: individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes (this consisted of an external examination and opening of the abdominal and thoracic cavities). The appearance of any macroscopic abnormalities was recorded. - Statistics:
- An estimate of the LD50 value was made according to the observed mortality rate.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The animal dosed at 2000 mg/kg was killed for humane reasons, eight days after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence.
None of the animals dosed at 300 mg/kg died during the study. - Clinical signs:
- other: Signs of systemic toxicity noted on the animal dosed at 2000 mg/kg included hunched posture, pilo-erection, tiptoe gait, emaciation, dehydration, and palor of the extremities and hypothermia. In the group dosed at 300 mg/kg clinical signs included hunched
- Gross pathology:
- Pale liver and kidneys were noted at necropsy in the animal dosed at 2000 mg/kg.
No abnormalities were noted at necropsy of animals dosed at 300 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the acute oral LD50 of the test material in the female Wistar strain rat was estimated to be in the range of 300 to 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test material was investigated in a GLP study which was conducted in accordance with the standardised guidelines OECD 420 and EU Method B.1 bis, following the fixed dose method.
Following a sighting test in a single animal dosed 2000 mg/kg bw, a group of five fasted females was given a single oral dose of test material, as a solution in dimethyl sulphoxide, at a dose level of 300 mg/kg bw. Clinical signs and bodyweight development were monitored during the study and all animals were subjected to gross necropsy at study termination on day 14.
The animal treated at 2000 mg/kg was killed for human reasons, eight days after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. There were no deaths in the group dosed at 300 mg/kg.
Signs of systemic toxicity noted in the animals treated at 2000 mg/kg were hunched posture, pilo-erection, tiptoe gait, emaciation, dehydration, pallor of the extremities and hypothermia. Ataxia and/or hunched posture were noted in animals treated at 300 mg/kg.
Pale liver and kidneys were noted at necropsy of the animal treated at 2000 mg/kg. No abnormalities were noted a necropsy of animals treated at a dose level of 300 mg/kg.
Under the conditions of the study the acute oral LD50 of the test material in the female Wistar strain rat was estimated to be in the range of 300 to 2000 mg/kg bw, and the discriminating dose was considered to be 300 mg/kg bw.
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.