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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-960-8 | CAS number: 1461-25-2
- 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
Endpoint summary
Administrative data
Description of key information
Mullaney (2004), the most recent study, is presented as the key study for acute oral toxicity as the reliability rating for this study is 1, according to the criteria of Klimisch et al. (1997).
The acute oral median lethal dose of the test material was estimated as being greater than 2500 mg/kg bodyweight.
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the rat following OECD Guideline 423.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 June 2004 to 28 June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 210 to 245 g
- Fasting period before study: overnight
- Housing: housed in groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: minimum of 5 days
Temperature: 19-25 ºC
Relative humidity: 30-70 %
Rate of air exchange: at least 15 changes per hour
Lighting: 12 hours of continuous light/darkness - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- - Justification for choice of vehicle: Test material did not dissolve/suspend in distilled water
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days with observations for deaths or overt signs of toxicity at 0.5, 1, 2 and 4 hours after dosing.
- Body weights were recorded prior to dosing and seven and fourteen days after treatment
- All animals were subject to gross pathological examination at the end of the study - Statistics:
- Data evaluations included the relationship, if any, between the exposure of the animal to the test material and the incidence and severity of all abnormalities including behavioral and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute oral median lethal dose of the test material was made.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Clinical signs:
- other: There were no signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg. Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia and pilo-erection. The animals appeare
- Gross pathology:
- No abonormalities detected at 300 mg/kg. Three of the five females had thickened non-gladular region of the stomach at the 2000 mg/kg dosage, no abnormalities were detected in the remaining animals .
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The acute oral median lethal dose of the test material was estimated as being greater than 2500 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the rat following OECD Guideline 423. Groups of three females were dosed with 300 mg/kg bw and 2000 mg/kg bw (two groups).
No deaths were observed. Clinical observations were only seen in animals in the 2000 mg/kg bw group but animals appeared normal after one or two days. All animals gained bodyweight over the test peirod and the non-glandular region of the stomach appeared thickened at necroscopy of three animals treated with 2000 mg/kg.
The LD50 of the test material was estimated to be >2500 mg/kg bw.
Reference
Table 1: Summary of Clinical Observations
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During period After Dosing (Days) |
||||||||||||||||
1/2 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
0 |
0 |
0 |
HO |
HLAP |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-1 Female |
0 |
0 |
0 |
0 |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
HLA |
HLAP |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-0 Female |
0 |
0 |
H |
HLAP |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
HA |
HAP |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
HA |
HAP |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 = No signs of systemic toxicity H = Hunched posture L = Lethargy A = Ataxia P = Pilo-erection |
Only the results from the 2000 mg/kg group are shown as no effects were observed in the lower dosing group.
Table 2: Observations of Bodyweight:
At 300 mg/kg Dosage Level | |||||
Bodyweight (g) at Day | Bodyweight Gain (g) During Week | ||||
Female | Day 0 | Day 7 | Day 14 | 1 | 2 |
1 -0 | 210 | 227 | 246 | 17 | 19 |
1 -1 | 211 | 242 | 249 | 31 | 7 |
1 -3 | 220 | 259 | 271 | 39 | 12 |
At 2000 mg/kg Dosage Level | |||||
Bodyweight (g) at Day | Bodyweight Gain (g) During Week | ||||
Female | Day 0 | Day 7 | Day 14 | 1 | 2 |
2 -0 | 216 | 255 | 261 | 39 | 6 |
2-1 | 245 | 279 | 295 | 34 | 16 |
2-2 | 242 | 269 | 280 | 27 | 11 |
3-0 | 236 | 256 | 264 | 20 | 8 |
3-1 | 230 | 270 | 281 | 40 | 11 |
3-2 | 213 | 227 | 236 | 14 | 9 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Four studies are available to address this endpoint; the key study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). The quality of the database id therefore considered to be high.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral route
In the key study, tetrabutylstannane [CAS # 1461-25-2] was examined for acute oral toxicity.
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the rat following OECD Guideline 423. Groups of three females were dosed with 300 mg/kg bw and 2000 mg/kg bw.
No deaths were observed. Clinical observations were only seen in animals in the 2000 mg/kg bw group but animals appeared normal after one or two days. All animals gained bodyweight over the test period and the non-glandular region of the stomach appeared thickened at necroscopy of three animals treated with 2000 mg/kg.
The LD50 of the test material was estimated to be >2500 mg/kg bw.
The following supporting studies are also available for information purposes only:
- In a Günzel (1969) study the LD50 was determined to be >4000 mg/kg.
- In the Calley (1967) paper tetrabutyltin exhibited a very low order of toxicity. The LD50 was determined to be 6000 ± 500 mg/kg.
- In the Schafer & Bowles (1985) paper the LDfr of tetrabutyltin for deer mice was equal to 913 mg/kg/day.
Dermal and Inhalation routes
No data has been provided for the dermal and inhalation routes as the oral route has been identified as more appropriate for exposure, in accordance with EC Regulation 1907/2006, Annex VIII, Column 2, point 8.5.
Also, no other routes need to be considered as the registration substance is a transported isolated intermediate and will therefore be used under strictly controlled conditions in line with article 18, 4.(b) of the REACH regulation EC/1907/2006 which states "procedural and control technologies shall be used that minimise emission and any resulting exposure", and therefore no exposure is expected. A CSR is not needed for this substance and DNEL values do not need to be calculated.
Justification for classification or non-classification
In accordance with the criteria for classification as set forth in Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity.
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.