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EC number: 245-152-0 | CAS number: 22673-19-4
- 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:
- 15 April 1998 and 03 June 1998.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted to a recognised guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dibutylbis(pentane-2,4-dionato-O,O')tin
- EC Number:
- 245-152-0
- EC Name:
- Dibutylbis(pentane-2,4-dionato-O,O')tin
- Cas Number:
- 22673-19-4
- Molecular formula:
- C18H32O4Sn
- IUPAC Name:
- Tin, dibutylbis(2,4-pentanedionato-kO2,kO4)-,
- Details on test material:
- - Name of test material (as cited in study report): NEOSTANN U-220
- Physical state: yellow liquid
- Lot/batch No.: TO-141
- Storage condition of test material: room temperature in the dark
- Other: Data relating to the identity, purity and stability of the test material are the responsibility of the Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: eight to twelve weeks old.
- Weight at study initiation: males weighed 205 to 215g, and the females 200 to 226g
- Fasting period before study: overnight fast immediately before dosing and for approximately two hours after dosing
- Housing: The animals were housed in groups of up to five by sex in solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): free access to food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Water (e.g. ad libitum): free access to mains drinking water was allowed throughout the study.
- Acclimation period: After a minimum acclimatisation period of five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 48 to 61 %.
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light):lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- For the purpose of the study the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. - Doses:
- 1000, 1414 and 2000 mg/kg
- No. of animals per sex per dose:
- 5 females per dose and 5 males tested only at 2000 mg/kg
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
At the end of the study the surviving animals were killed by cervical dislocation. All animals including those that died during the study, but excluding one that died during the study and was cannibalised, were subjected to gross pathological examination. This consisted of an external examination and examination of the major organs of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- The acute oral median lethal dose (LD50) and 95% confidence limits of the test material, NEOSTANN U-220, in the Sprague-Dawley CD strain rat were calculated by a probit method of Finney D J.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 864 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 039 - 3 344
- Mortality:
- The mortality data are given in Table 2.
Deaths were noted one to eight days after dosing. - Clinical signs:
- other: Common signs of systemic toxicity noted in all dose groups were ataxia, hunched posture and lethargy. Clinical observations noted in animals treated with 1414 or 2000 mg/kg were ptosis, decreased respiratory rate, laboured respiration and splayed or tipto
- Gross pathology:
- Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver or patchy pallor of the liver, pale spleen, dark kidneys, haemorrhagic gastric mucosa, sloughing of the non-glandular epithelium of the stomach and haemorrhage of the small and large intestines. One female animal treated with 1000 mg/kg that died during the study was found cannibalised. A necropsy was therefore not performed. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) and 95% confidence limits of the test material, NEOSTANN U-220, in the Sprague-Dawley CD strain rat were calculated by a probit method of Finney D J to be:
Females only = 1864 (1039 - 3344) mg/kg bodyweight
Male animals were not considered to be markedly more sensitive to the test substance than female animals. - Executive summary:
In an acute oral toxicity to rats study (SPL project number: 1194/001) the test material was found to have an acute oral median lethal dose (LD50) and 95% confidence limits of 1864 (1039 - 3344) mg/kg bodyweight (Females only).
The test material was classified as HARMFUL and the symbol "Xn" and risk phrase R 22 "HARMFUL IF SWALLOWED" are therefore required according to EU labelling regulations.
Male animals were considered not to be markedly more sensitive to the test material than female animals.
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