Registration Dossier
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EC number: 231-131-3 | CAS number: 7440-22-4
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- other: Standard reliability rating not applicable: Non standard test (in-vitro bioaccessibility). Methodology and results are very well documented.
Data source
Reference
- Reference Type:
- publication
- Title:
- Short term serum pharmacokinetics of diammine silver fluoride after oral application
- Author:
- Vasquez, E. et al.
- Year:
- 2 012
- Bibliographic source:
- BMC Oral Health 12:60, 1 - 7
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- This preliminary study determined the applied doses (3 teeth treated with test item), maximum serum concentrations, and time to maximum serum concentration for fluoride and silver in 6 adults over 4 hours. Fluoride was determined using the indirect diffusion method with a fluoride selective electrode, and silver was determined using inductively coupled plasma-mass spectrometry. A mean amount of 7.57 mg (6.04 μL) diammine silver fluoride solution was applied to 3 teeth of the participants.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: dissolution
- Details on test material:
- - Name of test material (as cited in study report): Diammine silver fluoride (DSF)(Saforide, Toyo Seiyaku Kasei Co. Ltd. Osaka, Japan)
- Molecular formula: Ag(NH3)2F
- Physical state: clear and colourless, with a weak odour of ammonia
- Composition of test material, percentage of components: The 38% solution contains 24.9 (w/v) silver (Ag), and 5.5% fluoride (F).
- Lot No.: 155060
- Specific gravity: 1.253 (25°C):
Test animals
- Species:
- human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Six healthy volunteers (4 females, mean age 36.2, range 23 -52 years) were recruited from staff members of the Universidad Católica de Santa María, Arequipa, Peru. Each had gingival recession exposing non-carious cementum. Participant were taking no medications and had most permanent teeth present.
Administration / exposure
- Route of administration:
- other: Three maxillary teeth (cuspid and premolars) in the same quadrant were treated with diammine silver fluoride.
- Duration and frequency of treatment / exposure:
- one application followed by a 4 hour observation period
Doses / concentrations
- Remarks:
- Doses / Concentrations:
The mean amount of DSF solution applied to the 3 teeth was 7.57 mg (6.04 µL).
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- Over the 4 hour observation period, the mean maximum serum concentrations were 1.86 µmol/L for fluoride and 206 nmol/L for silver. These maximums were reached 3.0 hours and 2.5 hours for fluoride and silver, resectively.
Applicant's summary and conclusion
- Conclusions:
- Over the 4 hour observation period, the mean maximum serum concentrations were 1.86 µmol/L for fluoride and 206 nmol/L for silver. These maximums were reached after 3.0 hours and 2.5 hours for fluoride and silver, resectively.
According to the authors, this preliminary study suggests that serum concentrations of fluoride and silver after topical application of DSF should pose little toxicity risk when used in adults.
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