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EC number: 215-716-0 | CAS number: 1345-07-9
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Statement
- Adequacy of study:
- key study
- Study period:
- 2013-04-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Expert Statement
Data source
Reference
- Reference Type:
- other: Expert Statement
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline required
Test material
- Reference substance name:
- Dibismuth trisulphide
- EC Number:
- 215-716-0
- EC Name:
- Dibismuth trisulphide
- Cas Number:
- 1345-07-9
- Molecular formula:
- Bi2S3
- IUPAC Name:
- dibismuth trisulphide
- Test material form:
- solid: crystalline
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- ASSESSMENT OF ABSORPTION
Assessment of potential absorption via oral/inhalation/dermal route according to REACH Guidance R7c is provided in Table 1, 2 and 3, respectively. Additional literature data on insoluble bismuth compounds is provided if available.
For detailed information please refer to the attached Statement.
2.1 ORAL ABSORPTION
The oral absorption of bismuth compounds depends on the solubility in the gastrointestinal tract. Therefore, insoluble bismuth compounds, e.g. dibismuth trisulfide, are poorly absorbed (Billon et al., 1976; Dresow et al., 1991; Thomas et al., 1977; Thomas et al., 1983; Lechat and Kisch, 1986).
Bismuth bioavailability from 205Bi-labeled compounds given to human volunteers showed a low bioavailability of 0.005 – 0.038 % depending on the compound (Dresow et al., 1992).
The site(s) of Bi absorption are unknown (Slikkerveer and de Wolff, 1996).
Taken together, based on the physical form and low water solubility, but mainly on the absence of toxicity in acute and repeated dose oral toxicity studies, oral absorption of dibismuth trisulfide is assumed to be very low. This conclusion is confirmed by the literature on oral absorption of insoluble bismuth compounds.
2.2 DERMAL ABSORPTION
Adequate data on uptake following dermal exposure are not available.
Taken together, the physical state, the molecular weight, the water solubility, the vapour pressure, but mainly the absence of toxicity in acute dermal animal testing and the absence of irritating or corrosive and sensitizing potential the dermal absorption of dibismuth trisulfide is assumed to be very low.
2.3 RESPIRATORY ABSORPTION
Adequate data on uptake following respiratory exposure are not available.
Taken together, the low vapour pressure and the tendency of dibismuth trisulfide particles to agglomerate and deposit do not favour the respiratory uptake, whereas the particle size and the low water solubility favour the assumption that particle can be absorbed on different stages of the stages of the respiratory tract and via the gastrointestinal tract. However, the absence of toxicity in acute inhalation toxicity and acute and repeated dose oral toxicity studies, the respiratory and oral absorption of dibismuth trisulfide is assumed to be very low. - Details on distribution in tissues:
- ASSESSMENT OF DISTRIBUTION
For detailed information please refer to the attached Statement.
Inorganic bismuth compounds are considered to be not able to penetrate the blood-brain barrier (Clarkson, 1979). Bismuth compounds induce the synthesis of a metal-binding protein, affecting its accumulation in the kidney (Zidenberg-Cherr et al., 1989).
Taken together, based on the low water solubility, but mainly based on the absence of target organs or signs of toxicity in a repeated dose toxicity study with the Read-Across substance bismuth in rats up to the limit concentration, distribution was considered minimal. Data from literature indicates accumulation in the kidney, however this is not considered to be relevant since the absorption of poorly water-soluble inorganic bismuth compounds is considered to be low.
- Details on excretion:
- ASSESSMENT OF EXCRETION
For detailed information please refer to the attached Statement.
Literature summarize that bismuth elimination from the body takes place by urinary and faecal routes (Slikkerveer and de Wolff, 1996).
Since the oral absorption of dibismuth trisulfide is very low, therefore the estimated favoured excretion route is the faecal route. However, very small quantities of absorbed and therefore dissolved parts are excreted via urine.
Metabolite characterisation studies
- Details on metabolites:
- It is discussed inconsistent if bismuth compounds are methylated within mammalian tissue (Clarkson, 1979; Hirner and Rettenmeyer, 2010).
Any other information on results incl. tables
References
Billon, J. P., Gernez, G., Gourdin, J. C., Martin, C., and Palliere, M. (1976) [Some physico-chemical properties of bismuth salts used in pharmacy].Ann Pharm Fr.34, 161-71.
Clarkson, T. W. (1979) Effects - General principles underlying the toxic action of metals. In Handbook on the Toxicology of Metals (L. Friberg, G. F. Nordberg and V. B. Vouk, eds.), Vol. 1, pp. 99-117. Elsevier/North-Holland Biomedical Press, Amsterdam.
Dresow, B., Nielsen, P., Fischer, R., Wendel, J., Gabbe, E. E., and Heinrich, H. C. (1991) Bioavailability of bismuth from205Bi-labelled pharmaceutical oral Bi-preparations in rats.Arch. Toxicol.65, 646-650.
Dresow, B., Fischer, R., Gabbe, E. E., Wendel, J., and Heinrich, H. C. (1992) Bismuth absorption from 205Bi-labelled pharmaceutical bismuth compounds used in the treatment of peptic ulcer disease.Scand. J. Gastroenterol.27, 333-336.
Hirner, A.V., Rettenmeyer, A.W. (2010) Methylated metal(loid) species in humans. Met ions Life Sci. 7: 465-521
Slikkerveer, A., and de Wolff, F. A. (1996) Toxicity of bismuth and its compounds. InToxicology of Metals(L. W. Chang, L. Magos and T. Suzuki, eds.), pp. 439-454. CRC Lewis Publishers, New York.
Thomas, D., and al, e. (1977) InClinical Chemistry and Clinical Toxicology of Metals(S. Brown and J. Savory, eds.), pp. 293-296. Elsevier/North Holland Biomedical Press, Amsterdam.
Thomas, D., Sobecki, S., Hartley, T., Coyle, P., and Alp, M. (1983) Variable absorption and excretion of bismuth and its potential for toxicity. InChemical Toxicology and Clinical Chemistry of Metals(S. Brown and J. Savory, eds.), pp. 391-394. Academic Press, London.
Lechat, P., and Kisch, R. (1986) [Bismuth encephalopathy: a reappraisal of risk factors]. Gastroenterol Clin Biol. 10, 562-569
Zidenberg-Cherr, S., Clegg, M.S., Parks, N.J., and Keen, C.L. (1989). Localization of bismuth radiotracer in rat kidney following exposure to bismuth. Biol Trace Elem Res., 19 (3): 185-194.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Based on the physical form and low water solubility, but mainly on the absence of toxicity in acute and repeated dose oral toxicity studies, oral absorption of dibismuth trisulfide is assumed to be very low. This conclusion is confirmed by the literature on oral absorption of insoluble bismuth compounds.
The physical state, the molecular weight, the water solubility, the vapour pressure, but mainly the absence of toxicity in acute dermal animal testing and the absence of irritating or corrosive and sensitizing potential the dermal absorption of dibismuth trisulfide is assumed to be very low.
The low vapour pressure and the tendency of dibismuth trisulfide particles to agglomerate and deposit do not favour the respiratory uptake, whereas the particle size and the low water solubility favour the assumption that particle can be absorbed on different stages of the stages of the respiratory tract and via the gastrointestinal tract. However, the absence of toxicity in acute inhalation toxicity and acute and repeated dose oral toxicity studies, the respiratory and oral absorption of dibismuth trisulfide is assumed to be very low.
Based on the low water solubility, but mainly based on the absence of target organs or signs of toxicity in a repeated dose toxicity study with the Read-Across substance bismuth in rats up to the limit concentration, distribution was considered minimal. Data from literature indicates accumulation in the kidney, however this is not considered to be relevant since the absorption of poorly water-soluble inorganic bismuth compounds is considered to be low.
There is no direct indication of bioaccumulation potential of dibismuth trisulfide in lung, adipose tissue, bone or stratum corneum. However, literature describes that bismuth compounds may accumulate in the kidney. Taking into account that absorption of dibismuth trisulfide is considered to be very low, accumulation is not considered to be relevant.
Since the oral absorption of dibismuth trisulfide is very low, therefore the estimated favoured excretion route is the faecal route. However, very small quantities of absorbed and therefore dissolved parts are excreted via urine.
For detailed information please refer to the attached statement. - Executive summary:
Based on the physical form and low water solubility, but mainly on the absence of toxicity in acute and repeated dose oral toxicity studies, oral absorption of dibismuth trisulfide is assumed to be very low. This conclusion is confirmed by the literature on oral absorption of insoluble bismuth compounds.
The physical state, the molecular weight, the water solubility, the vapour pressure, but mainly the absence of toxicity in acute dermal animal testing and the absence of irritating or corrosive and sensitizing potential the dermal absorption of dibismuth trisulfide is assumed to be very low.
The low vapour pressure and the tendency of dibismuth trisulfide particles to agglomerate and deposit do not favour the respiratory uptake, whereas the particle size and the low water solubility favour the assumption that particle can be absorbed on different stages of the stages of the respiratory tract and via the gastrointestinal tract. However,the absence of toxicity in acute inhalation toxicity and acute and repeated dose oral toxicity studies, the respiratory and oral absorption of dibismuth trisulfide is assumed to be very low.
Based on the low water solubility, but mainly based on the absence of target organs or signs of toxicity in a repeated dose toxicity study with the Read-Across substance bismuth in rats up to the limit concentration, distribution was considered minimal. Data from literature indicates accumulation in the kidney, however this is not considered to be relevant since the absorption of poorly water-soluble inorganic bismuth compounds is considered to be low.
There is no direct indication of bioaccumulation potential of dibismuth trisulfide in lung, adipose tissue, bone or stratum corneum. However, literature describes that bismuth compounds may accumulate in the kidney. Taking into account that absorption of dibismuth trisulfide is considered to be very low, accumulation is not considered to be relevant.
Since the oral absorption of dibismuth trisulfide is very low, therefore the estimated favoured excretion route is the faecal route. However, very small quantities of absorbed and therefore dissolved parts are excreted via urine.
For detailed information please refer to the attached statement.
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