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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 222-103-1 | CAS number: 3349-36-8
- 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
Carcinogenicity
Administrative data
Description of key information
The following study has been submitted to address the carcinogenicity endpoint:
EFSA (2004) Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the Commision to assess the health risks to consumers associated with exposure to organotins in foodstuffs (Question No EFSA-Q-2003-110). The EFSA Journal 102: 1-119.
As the reference is secondary literature, it has been allocated a Klimisch score of 4.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Scientific opinion of EFSA citing numerous studies on toxicological effects of oganotin compounds. The Committee preparing the document primarily focused on compounds for which both the toxicological and exposure databases were considered suitable. Data used in the assessment is cited only as short abstracts, and it is therefore not possible to evaluate the reliability of the individual studies reviewed in the document.
- Principles of method if other than guideline:
- Data reviewed and cited by EFSA in a publically available report addressing the potential effects of organotin concentration in food. Reference is made to a chronic (2 year) carcinogenicity study from NCI (1979) in which F344 rats and B6C3F1 mice were fed diets containing dibutyltin diacetate. Rats were dosed with 66.5 and 133 mg/kg dibutyltin diacetate and the mice were fed diets containing 76 and 152 mg/kg dibutyltin diacetate. Groups of 50 males and 50 females of each species were used. Data cited from: NCI (National Cancer Institute), 1979. Carcinogenesis. Bioassay of dibutyltin diacetate for possible carcinogenicity. Technical Report Series n. 183. US-NIH.
- GLP compliance:
- not specified
- Species:
- other: Rat and Mouse
- Strain:
- other: F344 Rats and B6C3F1 mice
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Remarks:
- Doses / Concentrations:
66.5 and 133 mg/kg dibutyltin diacetate in F344 rats
Basis: - Remarks:
- Doses / Concentrations:
76 and 152 mg/kg dibutyltin diacetate in B6C3F1 mice
Basis: - Control animals:
- yes
- Statistics:
- Results were tested for statistical significance in comparison to controls
- Details on results:
- No statistically significant increased in tumour incidences were observed in dosed rats or mice compared to the control. An accidental loss of tissues from high dose female rats prevented an evaluation of the carcinogenicity of dibutyltin diacetate in female rats.
- Dose descriptor:
- NOAEL
- Effect level:
- 133 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No increased tumours up to the top dose (133 ppm in the diet) in males
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 152 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No increased incidence of tumours in mice up to the top dose (152 ppm in the diet)
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- In a two year carcinogenicity study performed in F344 rats and B6C3F1 mice, no increase in the incidence of tumours was noted in either species up to the highest dose tested.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 0.025 mg/kg bw/day
- Study duration:
- chronic
- Species:
- other: mouse and rats
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
No data is available for the substance itself. Limited data from a presumably robust study indicated dibutyltin diacetate not to be carcinogenic in mice or in male rats; data for female rats was compromised by loss of tissues and no conclusion can be drawn.
A read-across approach was considered appropriate between dibutyltins. Under gastric conditions dibutyltins are hydrolysed to form dibutyltin chloride. This is demonstrated in various dibutyltin compounds presented in the TNO report V5047, (presented as individual reports as under Toxicokinetics).
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.