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Diss Factsheets
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EC number: 233-790-2 | CAS number: 10361-43-0
- 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
The following studies have been conducted with closely related read-across substances:
Bismuth subsalicylate was not mutagenic in the reverse mutation assay (Ames Test) with Salmonella typhimurium, tested at doses up to 666µg/plate.
Bismuth (III) trinitrate was not mutagenic in an in vitro mutation test in E. coli bacteria, tested up to 100 nmol/tube.
In a mammalian gene mutation test, bismuth subnitrate did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells when tested under the conditions employed in this study. These conditions 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).
Bismuth subnitrate was tested in a chromosome aberration assay using Chinese hamster V79 lung cells according to OECD Guideline 473. Bismuth subnitrate did not induce a significant level of chromosome aberrations in a repeatable, dose-dependent way in the performed experiments with or without metabolic activation. Therefore, bismuth subnitrate is considered not clastogenic in this test system.
Bismuth subsalicylate was tested in vitro in a chromosome aberration assay using Chinese hamster V79 lung cells according to OECD Guideline 473. Bismuth subsalicylate did not induce a significant level of chromosome aberrations in a repeatable, dose-dependent way in the performed experiments with or without metabolic activation. Therefore, bismuth subsalicylate is considered not clastogenic in this test system.
Justification for selection of genetic toxicity endpoint
No one study is selected as five studies are available with negative results.
Short description of key information:
By read-across to an Ames test (OECD Guideline 471) and a chromosome aberration test (OECD Guideline 473) with bismuth subsalicylate, a chromosome aberration test (OECD Guideline 473) and a mammalian gene mutation study with bismuth subnitrate and a bacterial gene mutation test with bismuth trinitrate, bismuth hydroxide is not classified for genetic toxicity. A read-across approach is considered acceptable due to the presence of the common bismuth component.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Bismuth hydroxide is not classified for genetic toxicity by read-across to the negative results of an Ames Test (OECD Guideline 471) and a chromosome aberration study (OECD Guideline 473) with bismuth subsalicylate, a bacterial gene mutation test with bismuth trinitrate, a chromosome aberration study (OECD Guideline 473) and a mammalian gene mutation study with bismuth subnitrate.
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