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EC number: 215-136-8 | CAS number: 1304-85-4
- 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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 68.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step, followed by a correction for the difference between respiratory rates of workers under standard conditions and under light activity in the second step. NAECcorr_inh = oral NOAEL (1000) x 1/0.38 m3/kg bw x 6.7 m3/10 m3 = 1763 mg/m3. Oral absorption is very low in rats and can per default be assumed at about 0.5 % (D’Souza and Francis, 1987). The estimated percentage of bismuth subnitrate absorbed via inhalation is in the range 1.0% to 12.9% (see Chapter 7.1 Toxicokinetics for explanation). Therefore, correction factor for differences in the rates of absorption for the oral and the inhalation routes in rats and humans is: ABS human-inhalation ÷ ABS rat-oral = 12.9/0.5 = 25.8. Therefore, NAECcorr_inh = 1763 mg/m3/25.8 = 68.3 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
There is a 90 day repeated dose oral toxicity study (OECD 408) available, which characterised the potential toxic effects of bismuth subnitrate. A NOAEL of 1000 mg/kg bw/day was established for bismuth subnitrate in this study based on the lack of toxicologically relevant effects at the highest dose tested. There is also a prenatal developmental toxicity study (OECD 414) available for bismuth subnitrate. In this study, the NOEL for maternal toxicity was considered to be 1000 mg/kg bw/day. No treatment-related changes were detected in the offspring parameters measured therefore the NOEL for developmental toxicity was also considered to be 1000 mg/kg bw/day. The NOAEL from the 90 day study is selected as the starting point for DNEL derivation for long-term systemic effects via inhalation because this is the study with the longest duration.
No dermal DNELs were derived as dermal absorption of bismuth is expected to be negligible and bismuth subnitrate was shown to be not irritating to the skin in an in vitro test. Local and acute inhalation DNELs were not derived because an acute inhalation study with read-across substance, dibismuth trioxide, in rats did not indicate any significant systemic or local effects up to the threshold of 5 mg/l air.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 33.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step. NAECcorr_inh = oral NOAEL (1000) x 1/1.15 m3/kg bw = 869.6 mg/m3. Oral absorption is very low in rats and can per default be assumed at about 0.5 % (D’Souza and Francis, 1987). The estimated percentage of bismuth subnitrate absorbed via inhalation is in the range 1.0% to 12.9% (see Chapter 7.1 Toxicokinetics for explanation). Therefore, correction factor for differences in the rates of absorption for the oral and the inhalation routes in rats and humans is: ABS human-inhalation ÷ ABS rat-oral = 12.9/0.5 = 25.8. Therefore, NAECcorr_inh = 869.6 mg/m3/25.8 = 33.7 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor of 10 for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation required. Assuming that oral absorption in rats = oral absorption in humans.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default assessment factor for extrapolation from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Factor for allometric scaling for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor for good/standard quality of database (Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 1
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There is a 90 day repeated dose oral toxicity study (OECD 408) available, which characterised the potential toxic effects of bismuth subnitrate. A NOAEL of 1000 mg/kg bw/day was established for bismuth subnitrate in this study based on the lack of toxicologically relevant effects at the highest dose tested. There is also a prenatal developmental toxicity study (OECD 414) available for bismuth subnitrate. In this study, the NOEL for maternal toxicity was considered to be 1000 mg/kg bw/day. No treatment-related changes were detected in the offspring parameters measured therefore the NOEL for developmental toxicity was also considered to be 1000 mg/kg bw/day. The NOAEL from the 90 day study is selected as the starting point for DNEL derivation for long-term systemic effects via inhalation and long-term oral systemic effects because this is the study with the longest duration.
No acute oral systemic DNEL was derived because an acute oral toxicity study with read-across substance, bismuth subsalicylate, in rats did not indicate any systemic effects up to the threshold of 2000 mg/kg bw/day. No dermal DNELs were derived as dermal absorption of bismuth is expected to be negligible and bismuth subnitrate was shown to be not irritating to the skin in an in vitro test. Local and acute inhalation DNELs were not derived because an acute inhalation study with read-across substance, dibismuth trioxide, in rats did not indicate any significant systemic or local effects up to the threshold of 5 mg/l air; in addition, the general population is not expected to be at risk by this route of exposure.
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