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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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study according guideline, glp. Only draft report available, discrepance between study summarey and raw data. Study in reevaluation; study not finaliesed
Data source
Reference
- Reference Type:
- other: Draft Report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- Determination of Sn in plasma
- Principles of method if other than guideline:
- Additional dtermination of Sn in plasma
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 483-270-6
- EC Name:
- -
- Cas Number:
- 54068-28-9
- Molecular formula:
- Hill formula: C26H48O4Sn CAS formula: C26H48O4Sn
- IUPAC Name:
- (3Z)-4-{[dioctyl({[(2Z)-4-oxopent-2-en-2-yl]oxy})stannyl]oxy}pent-3-en-2-one
- Test material form:
- solid - liquid: suspension
- Remarks:
- migrated information: dispersion
- Details on test material:
- -
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- -
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on mating procedure:
- One male was paired with one female of the same treatment group for up to 15 days (actual duration
required for pairing was up to four days). Mating was confirmed by the presence of sperm in a
vaginal smear or a retained vaginal plug. The day in which mating was confirmed was designated as
Day 0 of gestation.
Pairing took place after two weeks of treatment.
Due to the death of animal 68 (Group 2F) on Day 16 of the study, animal 18 was paired with an
untreated female (animal 501).
Mating was confirmed on Day 17 of the study, and the female was sent to necropsy on Day 13 of
gestation. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- -
- Duration of treatment / exposure:
- 6 weeks, additional 2 weecks for recovering group without dosing
- Frequency of treatment:
- daily by oral gavage
- Details on study schedule:
- not relevant
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Doses / Concentrations:
0 mg/kg day/bw
Basis:
analytical conc.
- Dose / conc.:
- 4 mg/kg bw/day
- Remarks:
- Doses / Concentrations:
4 mg/kg day/bw
Basis:
analytical conc.
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
20 mg/kg day/bw
Basis:
analytical conc.
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- Doses / Concentrations:
50 mg/kg day/bw
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 female, 10 male
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- --
- Positive control:
- not relevant
Examinations
- Parental animals: Observations and examinations:
- -
- Oestrous cyclicity (parental animals):
- -
- Sperm parameters (parental animals):
- -
- Litter observations:
- -
- Postmortem examinations (parental animals):
- -
- Postmortem examinations (offspring):
- -
- Statistics:
- --
- Reproductive indices:
- -
- Offspring viability indices:
- -
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- -
- Dermal irritation (if dermal study):
- not examined
- Description (incidence and severity):
- -
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- -
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- -
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- -
- Food efficiency:
- not specified
- Description (incidence and severity):
- -
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- -
- Ophthalmological findings:
- not specified
- Description (incidence and severity):
- -
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- -
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- -
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- -
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- taste of the test substance causes stress in the test animals-
- Immunological findings:
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- -
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- -
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- -
- Other effects:
- not specified
- Description (incidence and severity):
- -
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, non-treatment-related
- Description (incidence and severity):
- -
- Reproductive function: sperm measures:
- effects observed, non-treatment-related
- Description (incidence and severity):
- -
- Reproductive performance:
- effects observed, non-treatment-related
- Description (incidence and severity):
- -
Details on results (P0)
Effect levels (P0)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: small thymus - maternal toxicity
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 4 mg/kg bw/day (nominal)
- System:
- immune system
- Organ:
- other: thymus
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Dermal irritation (if dermal study):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Mortality:
- not examined
- Description (incidence):
- not relevant according to OECD 422
- Body weight and weight changes:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Food consumption and compound intake (if feeding study):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Food efficiency:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Water consumption and compound intake (if drinking water study):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Ophthalmological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Haematological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Clinical biochemistry findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Urinalysis findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Behaviour (functional findings):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Immunological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Organ weight findings including organ / body weight ratios:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Gross pathological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Neuropathological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Histopathological findings: non-neoplastic:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Histopathological findings: neoplastic:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Other effects:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Details on results:
- not relevant according to OECD 422
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Dermal irritation (if dermal study):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Mortality / viability:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Body weight and weight changes:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Food consumption and compound intake (if feeding study):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Food efficiency:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Water consumption and compound intake (if drinking water study):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Ophthalmological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Haematological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Clinical biochemistry findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Urinalysis findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Sexual maturation:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Organ weight findings including organ / body weight ratios:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Gross pathological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Histopathological findings:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
- Other effects:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
- Description (incidence and severity):
- not relevant according to OECD 422
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- other: not relevant according to OECD 422
- Generation:
- other: not relevant according to OECD 422
- Effect level:
- 0 other: not relevant according to OECD 422
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: not relevant according to OECD 422
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- not specified
- Lowest effective dose / conc.:
- 0 other: not relevant according to OECD 422
- System:
- other: not relevant according to OECD 422
- Organ:
- other: not relevant according to OECD 422
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- not specified
- Lowest effective dose / conc.:
- 4 mg/kg bw/day (nominal)
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- no
Any other information on results incl. tables
no maleformations found.
Problems in the lactation phase, see ovarall remarks.
Applicant's summary and conclusion
- Conclusions:
- The LOEAL for maternal toxicty was determined to be 4 mg/kg bw /day, for unschuedled deads and decrease in bw at 20 mg/kg bw/day. There were no adverse effects belonging to reproduction according to the FDA guidelines.
Many litters in the dose groups found dead without milk in the stomach. The data from necropsy show no evidence for adverse effects relating to teats of the dams including no or a decreased milk volume, or the litters could not drink. An analysis of the milk was not performed in due it is not part of the guideline OECD 422. So it is not possible to bevaluate the study in the lactation periode - Executive summary:
-
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