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Diss Factsheets
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EC number: 231-141-8 | CAS number: 7440-31-5
- 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
According to column 2 (specific rules for adaptation from column 1) point 8.9.1, under Annex X of the regulation EC no. 1907/2006, a study may be proposed if:
- the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and
- the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
As the substance was found to be non-mutagenic from the conclusions of the genetic toxicity tests, and no neoplastic histopathology was noted in the repeated dose studies, and there are no such known reports in humans in the public domain, testing for this endpoint is not required.
Furthermore, in the supporting information provided by Oppenheimer BS et al. (1956), tin foil discs failed to produce any response when subcutaneously implanted; in addition, several other metal foils all from a similar position to tin in the periodic table induced tumours in mice.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to carcinogenicity as the available data indicates that there is no reason for concern.
Additional information
Oppenheimer BS et al. (1956) was provided as supporting data only. The study was not performed in compliance with GLP or a current guideline, and the level of reporting lacked some detail; as such the study was assigned a reliability score of 4 under the criteria of Klimisch et al. (1997).
In accordance with point 8.9.1., column 2 (specific rules for adaptation from column 1) of Annex IX, regulation EC no. 1907/2006, the study may be proposed if:
the substance has a "widespread dispersive use" or there is evidence of frequent or long term human exposure, AND the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
Although use maybe considered widespread and dispersive, the material is not mutagenic and does not cause proliferative lesions (McRae, 2010, Robertson, 1960). Hence carcinogenicity work is not triggered.
It can be seen from the toxicokinetic data (which utilised extreme exposures), when put into the context of normal human background dietary exposure and plasma concentrations, that metalic tin would not be absorbed by the oral route to any detectable degree under normal occupational exposure conditions (see the toxicokinetics, metabolism and distribution section i.e. absorption for risk assessment purposes can be considered zero). The additional pathology conducted in the acute inhalation toxicity study (Gaunt, 2009) also showed that there would be no practical systemic absorption of metallic tin, via the inhalation or for that matter dermal routes of exposure. Tin did not exhibit any toxic effects in the 28 day oral gavage study in rats up to the limit dose of 1000 mg/kg bw/day. The substance has no significant solubility. Industrial working practices and food standards ensure that the the potential for exposure is extremely limited (see Waivers for Subchronic and Chronic toxicity) There is no anticipated consumer exposure where tin is in massive solid metallic form either pure or in an alloy).
There are no effects anticipated from the structure of metallic tin (metallic tin is anyway an inorganic substance), and there are no other dangerous properties anticipated that would notionally only manifest after chronic dosing.
Available human data also rules out any long term toxicological effects including tumours. Robertson J (1960) studied stannosis (tin oxide induced pneumoconiosis) in workers from a tin smelting works. Even with positive X-ray findings, workers with many years of exposure suffered no health effects, deposition of the dust in the lungs did not lead to a fibrous response (i.e. no adverse pathological effects), indicating no cellular interaction. Observations were performed on workers exposed later in the production line, such as ingot casters exposed to pure molten tin, which reports that there is little dust or fume exposure during this process and changes were not observed in these workers. Though the working conditions are not comparable to today’s practices (much improved), it gives a worst case scenario of exposure during various points of the lifecycle of tin metal.
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.