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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-585-0 | CAS number: 12013-46-6
- 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
From the studies, it is concluded that dietary exposure to levels of Tin (II) oxide and Tin (IV) dioxide up to 1% for 13 and 4 weeks respectively, did not induce any effect in rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
From existing studies of toxicokinetic profiles of Tin (IV) dioxide and Tin (II) oxide, it can be concluded that the toxicokinetic profiles of the two substances appear to be similar. Minor differences between Tin (II) and Tin (IV) in their absorption and distribution indicate that Tin (II) may be a bit more toxic than Tin (IV). Therefore Tin (II) oxide can be used as a structural surrogate for Tin (IV) dioxide in the 90 days repeated toxicity test.
In the test, groups of rats (Wistar; n=10/sex/group) were fed diets containing 0, 0.03, 0.10, 0.30, or 1.00% of various tin salts or oxides for periods of 13 weeks for Tin (II) oxide and 4 weeks for Tin (IV) dioxide, respectively. Effects on behaviour, mortality, body weights, food consumption, blood, urine, biochemical parameters, and organ weights were examined; and gross microscopic examinations were performed. No adverse effects were noted at any dose of tin oxides, as well as stannous sulphide and oleate. However, severe growth retardation, decreased food efficiency, slight anaemia, and slight histological changes in the liver were observed with 0.3% or more of stannous chloride, orthophosphate, sulphate, oxalate, and tartrate (De Groot et al, 1973). The authors concluded that the differences in response to different tin compounds suggested that insoluble tin compounds are relatively harmless whereas cationic tin compounds soluble in water or dilute acid may be toxic at dietary levels above 0.1%. From these studies, it is concluded that dietary exposure to levels of Tin (II) oxide and Tin (IV) dioxide up to 1% for 13 and 4 weeks respectively, did not induce any effect in rats.
Therefore the NOAEL of Tin (IV) dioxide was considered to be 1 % in diet for rat (NOECmammal, food_chr). (1% in diet is equivalent to 10000 mg/kg diet)
According to REACH guidance “Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment” the NOAELmammal, food_chr= NOECmammal, food_chr/ CONVmammal(CONVmammal for Rattus norvegicus (> 6 weeks) was default as 20). The NOAEL of Tin (IV) dioxide to rat, 500 mg/kg bw per day can be estimated by above method.
Repeated dose toxicity: via oral route - systemic effects (target organ) other: all gross lesions and masses
Justification for classification or non-classification
Based on the NOAEL of 500 mg/kg bw/day is above the criteria value of STOT RE 100 mg/kg bw, the substance is not need to be classified under Regulation (EC) No 1272/2008 for any category of Specific target organ toxicity - repeated exposure. For the same reason it does not satisfy with the classification criteria of Directive 67/548/eec.
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.