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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 483-270-6 | CAS number: 54068-28-9
- 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
Immunotoxicity
Administrative data
Description of key information
The immunotoxicity caused by Dioctyltin is an acute effect
Key value for chemical safety assessment
Effect on immunotoxicity: via oral route
Link to relevant study records
- Endpoint:
- immunotoxicity: acute oral
- Remarks:
- Part of the ongoing study on the read across substance Dioctyltin oxide. This final study will be submitted later based on ECHA decision number CCH-D-2114340406-56-01/F and INC000000190412.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- JUSTIFICATION OF READ ACROSS
Hydrolysis under stomach condition (pH 1.2) of Diotyltin bis(pentadione) into Dioctyltin oxide and pentadione (cp. Section basic toxicokinetics:) - Reason / purpose for cross-reference:
- other: Hydrolysis under stomach condition (pH 1.2)
- Reason / purpose for cross-reference:
- other: Main study (OECD 414, rat)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 85-7 (Immunotoxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- see attached report: study performed as port of an OECD 414 study
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Route of administration:
- oral: feed
- Vehicle:
- other: in diet
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 72 h
- Frequency of treatment:
- in diet
- Dose / conc.:
- 0 mg/kg diet
- Remarks:
- 0 mg/kg bw/day
- Dose / conc.:
- 5 mg/kg diet
- Remarks:
- 0-4 mg/kg bw/day
- Dose / conc.:
- 25 mg/kg diet
- Remarks:
- 1.8 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg diet
- Remarks:
- 11.8 mg/kg bw/day
- No. of animals per sex per dose:
- 5 in control, low and mid dise, 4 in high dose group
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale:
Subpart of OECD 414 study in rat, test substance Dioctyltin oxide. So rationale for dose selection is the main study. Dose selection form outcome of former studies with Dioctyltin oxide ((Waalkens-Berendsen, OECD 422, DOTO)
- Rationale for selecting satellite groups:
Determination of immunotoxicity as maternal toxicity
- Post-exposure recovery period in satellite groups:
Not planed, but time of last exposure to necropsy showed recovery of the immune system of test animals
- Rationale for animal assignment (if not random):
Subpart of OECD 414 study in rat, test substance Dioctyltin oxide
- Other:
Immunophenotyping:
Immunophenotyping was performed on Immunotoxicity animals from blood samples (0.5mL in EDTA) during the predose phase and on Gestation Days 7 (24 hours after first dose), 8 (48 hours after first dose), 9 (72 hours after first dose) and 10 (prior to necropsy)
Cytokine Measurement:
Blood samples (0.5 mL in serum separator tubes) were collected from Immunotoxicity cohort animals during the predose phase and on Gestation Days 7 (24 hours after first dose), 8 (48 hours after first dose), 9 (72 hours after first dose) and 10 (prior to necropsy) - Observations and clinical examinations performed and frequency:
- Immunophenotyping:
Immunophenotyping was performed on Immunotoxicity animals from blood samples (0.5mL in EDTA) during the predose phase and on Gestation Days 7 (24 hours after first dose), 8 (48 hours after first dose), 9 (72 hours after first dose) and 10 (prior to necropsy)
Cytokine Measurement:
Blood samples (0.5 mL in serum separator tubes) were collected from Immunotoxicity cohort animals during the predose phase and on Gestation Days 7 (24 hours after first dose), 8 (48 hours after first dose), 9 (72 hours after first dose) and 10 (prior to necropsy) - Positive control:
- not required
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- In the moin OECD 414 study no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- In the moin OECD 414 study no effects observed
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- In the moin OECD 414 study no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Description (incidence and severity):
- not reported at the moment, if findings, report in endpoint of main OECD study
- Clinical biochemistry findings:
- not examined
- Description (incidence and severity):
- not reported at the moment, if findings, report in endpoint of main OECD study
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- see section specific immunotoxic examinations
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 4ß percent of thymus decrease in high dose group
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Description (incidence and severity):
- not reported at the moment, if findings, report in endpoint of main OECD study
- Histopathological findings: neoplastic:
- not examined
- Description (incidence and severity):
- not reported at the moment, if findings, report in endpoint of main OECD study
- Other effects:
- not examined
- Description (incidence and severity):
- not reported at the moment, if findings, report in endpoint of main OECD study
- Details on results:
- not reported at the moment, if findings, report in endpoint of main OECD study
- Cell viabilities:
- effects observed, treatment-related
- Description (incidence and severity):
- Blood
At gestation Day 9, activated B lymphocyte numbers (CD3-/CD45RA+/CD25+) were markedly higher than the control group animals (approximately 3 to 4 times for the majority of the animals) at the 11.8mg/kg/day dose level.
Other observed differences, were limited to several lymphocyte sub-populations and tended to be slight to moderate in nature. On gestation Day 9, moderate increases were noted for CD3+/CD8+/CD25+, CD3+/CD25+ and CD3+/CD4+/CD25+ cell counts in animals dosed 11.8mg/kg/day. When compared to the control group results, the aforementioned populations were +85%, +60% and +50% greater, respectively.
At gestation Days 8 and 10, all groups administered Dioctyltin Oxide, displayed slightly lower numbers and relative percentages of NK cells (CD3-/CD161a+) when compared to the control group, although results within the treated groups were relatively unchanged when compared to other sampling days. No other changes of note were observed on Days 8 and 10.
Cytokines
Results for serum concentrations of IL-2 varied from day to day, with almost all animals, across all groups including controls, displaying quantifiable results on Days 8 and 10, but no animals recording results above the lower limit of quantitation (LLOQ) on Day 10. No test article-related effect could be determined, as the frequency and magnitude of quantifiable IL-2 were similar across all groups, and comparable to the results observed during the pre-dose phase. Quantifiable results, where observed were either slightly above the LLOQ value, or at least within 3 times the LLOQ value. - Humoral immunity examinations:
- not examined
- Specific cell-mediated immunity:
- not specified
- Non-specific cell-mediated immunity:
- not specified
- Other functional activity assays:
- not examined
- Other findings:
- not specified
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 11.8 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- immunology
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1.8 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- immunology
- Key result
- Critical effects observed:
- not specified
- Lowest effective dose / conc.:
- 11.8 mg/kg bw/day (nominal)
- System:
- immune system
- Organ:
- thymus
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- no
- Conclusions:
- The LOAEL for acute immune toxicity for Dioctyltin oxide was determined to be 11.8 mg / kg bw7day thus a NOAEL of 1.8 mg/kg bw7day results.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 11.8 ng/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- -
Effect on immunotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on immunotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Several demonstrate clearly, the the immunotoxicity of Dioctyltin is a acute effect. The adverese effects related to the immune system takes place hours after administration of the test substance to the animals. A few hours later there is to changes in the thymus, too.
Justification for selection of effect on immunotoxicity via
oral route endpoint:
use of an acuty study, to effect, itest type subacute is chosen in
due to default selection criteria
Justification for classification or non-classification
In due to mechanism DOT is to classify as STOT Single 2
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.