Registration Dossier
Registration Dossier
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EC number: 231-177-4 | CAS number: 7440-69-9
- 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
Key value for chemical safety assessment
Additional information
According to Annexes VII and VIII, point 8.4 of Regulation No 1907/2006 information on mutagenicity of substances shall be provided.
No published data or studies for determination the mutagenicity of bismuth metal are available. A new study with this substance can hardly be conducted in accordance with the guidelines, since elemental bismuth is only slightly soluble in water.
However, there are publications available in which soluble bismuth salts were tested. Colloidal bismuth subcitrate was tested to induce sister chromatid exchanges or chromosome aberrations and bismuth subsalicylate and bismuth nitrate were both tested to induce gene mutation in bacterial cells. There is no indication for genotoxic/mutagenic effects of either colloidal bismuth subcitrate, bisuth subsalicylate or bismuth nitrate in these available publications.
In addition, in an available guideline study with the soluble bismuth hydroxide nitrate oxide the gene mutation potential was determined in the hprt locus of L5178Y mouse lymphoma cells. The study included treatments up to the maximum practicable concentration, 140 µg/mL (limited by solubility in the primary vehicle), in two independent experiments in the absence and presence of a rat liver metabolic activation system (S9).
Results show that bismuth hydroxide nitrate oxide does not induce gene mutation in mouse lymphoma cells.
Due to the fact, that soluble bismuth compounds are not mutagenic, it can be considered that bismuth metal as a poorly soluble substance (resulting in a lower bioavailability) is not mutagenic or genotoxic and should not be classified as such.
Short description of key information:
Bismuth metal is not genotoxic by read across.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No data about genetic toxicity of bismuth metal are available.There are publications available in which soluble bismuth salts were tested. There is no indication for genotoxic/mutagenic effects of either colloidal bismuth subcitrate, bismuth subsalicylate or bismuth nitrate in these available publications. In addition, in an available guideline study with the soluble bismuth hydroxide nitrate oxide no gene mutation potential was determined in the hprt locus of mouse lymphoma cells. Bismuth hydroxide nitrate oxide should not be classified and labelled according to regulation (EC) No.1272/2008.
Due to the fact, that soluble bismuth compounds are not mutagenic, it can be considered that bismuth metal as a poorly soluble substance (resulting in a lower bioavailability) is not mutagenic or genotoxic and should not be classified as such.
Based on available data from publications and on experimental results with bismuth hydroxide nitrate oxide, bismuth metal does not need to be classified for genetic toxicity.
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