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EC number: 947-037-7 | CAS number: -
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- At this tonnage band a expert statement is sufficient to fullfill the data requirements
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Evaluation of available toxicity studies with regard to toxico kinetic behaviour
- Objective of study:
- other: overall expert evaluation of available data
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Evaluation of available toxicity data with regard to toxicokinetic information.
- GLP compliance:
- no
- Remarks:
- not required
- Details on absorption:
- Based on the subacute (28-day) oral toxicity study absorption of toxicologically significant amounts of Sanodal Gold 4N via the gastrointestinal tract has to be assumed since effects in the stomach and kidneys were observed. Systemic availability seems to be negligible after dermal exposure since no systemic signs of intoxication were seen after occlusive administration of 5000 mg Sanodal Gold 4N per kg body weight in rats in the acute dermal toxicity study. Indications of a significant dermal absorptive potential were also not revealed by testing for primary irritation in rabbits. The notion of very limited dermal absorption is also corroborated by the high water solubility of 257 g/L.
- Details on distribution in tissues:
- Based on the results of the subacute oral toxicity study findings observed in the stomach and kidneys, it can be concluded, that Sanodal Gold 4N is absorbed through the gastrointestinal tract and systemically available within the organism. Histopathological findings do not indicate a deposition of the material as such in the affected tissues but the formation of oxalic acid and calcium oxalate in the kidneys.
There were no signs of bioaccumulation of the test material. This view is supported by the physical-chemical properties (high solubility in water) and the molecular structure. - Details on excretion:
- Taking into account the physico-chemical properties and the molecular structure of the material it can be assumed that the main route of excretion will be the kidney. Nevertheless, a significant part of the dose is expected to just pass through the digestive tract without being absorbed. This notion is confirmed by the high water solubility and the limited capacity of the mammalian organism to absorb highly charged ionic compounds
- Metabolites identified:
- no
- Details on metabolites:
- Sanodal Gold 4N proved to be inactive in the Ames-test with and without exogenous metabolic activation. It was not genotoxic in the HPRT and chromosomal aberration assay in vitro. This indicates that Sanodal Gold 4N does not form mutagenic metabolites. Probable metabolites are oxalic acid and the corresponding calcium salt. Modelling of the metabolic fate of the test material using NEXUS-METEOR did also give an indication of hydrolysis as the probable metabolism.
Effects were seen in the subacute study in directly (stomach) and indirectly (kidney) exposed tissues. Functional and structural impairments were detected. Therefore, Sanodal Gold 4N is considered to pass through the organism with significant metabolism. The interaction being attributed to hydrolysis with the formation of free iron3+ and oxalic acid giving rise to the effects observed in stomach and kidneys. Depending on the dose the capacity of the excretion mechanisms may become exhausted leading to a temporary deposition of the components, especially calcium oxalate crystals in the kidneys. - Conclusions:
- Based on all available data, Sanodal Gold 4N does not exhibit conspicuous toxicokinetic behaviour in the sense of accumulative and/or delayed effects with regard to the individual parameters absorption, distribution, metabolism and excretion.
The results from studies with dermal exposure do not indicate that Sanodal Gold 4N has a definite dermal absorptive potential. Sanodal Gold 4N is absorbed from the gastrointestinal tract in significant amounts.
Metabolism via hydrolysis to form oxalic acid is considered probable. A bio-accumulative potential is not expected as the material as well as the expected metabolites are water soluble and no delayed toxicity occurred. Additionally no increase in severity of systemic effects was observed in the subacute oral toxicity study compared to the acute studies, which points to no bio-accumulation potential as well as to effective excretion of Sanodal Gold 4N and/or metabolites. - Executive summary:
Based on the available data base on Sanodal Gold 4N relevant information exists to make a qualitative evaluation of the toxicokinetic profile of this compound. This is in line with animal welfare considerations because additional animal tests can be avoided by such an evaluation.
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Sanodal Gold 4N. The data indicate that there is no relevant dermal absorption. On the other hand, Sanodal Gold 4N is absorbed from the gastro-intestinal tract in toxicologically significant amounts. Metabolism via hydrolysis to form oxalic acid is considered probable. Indications of a bio-accumulative potential as well as a metabolism towards genotoxic sub-structures do not exist. Excretion of systemically available Sanodal Gold 4N and/or potential metabolites via the kidney can be assumed.
Reference
Toxicokinetic parameters such as uptake, distribution, metabolism and excretion form part of the essential toxicological profile of a substance. Although the toxicokinetic behaviour of substances does not describe a toxicological endpoint itself, an approximate indication of the individual toxicokinetic parameters absorption, distribution, metabolism and excretion (ADME) can be gained from the results of basic toxicity testing. In this respect, the following evaluation discusses results and observations from basic toxicity studies, which can be used as approximate indications for the description of the individual toxicokinetic parameters. Such an approach is justified by animal welfare considerations because additional animal testing can be avoided. The assessment of the toxicokinetic properties of Sanodal Gold 4N given below is based on the results obtained for the following toxicological endpoints:
· Acute oral toxicity
· Acute dermal toxicity
· Skin irritation
· Eye Irritation
· Skin sensitisation
· HGPRT-test
· In vitro cytogenetic assay
· Subacute (28-day) oral toxicity
· Reproductive toxicity screening
These studies mostly were carried out according to the principles of Good Laboratory Practice and met the requirements of the OECD and EU-Guidelines for the Testing of Chemicals.
Simultaneously reference to physico-chemical data such as solubility, log Powand hydrolytic stability are included in the evaluation. This information gives additional indications regarding special toxicokinetic parameters, e.g. distribution, metabolism and excretion.
Description of key information
Based on the available data base on Sanodal Gold 4N relevant information exists to make a qualitative evaluation of the toxicokinetic profile of this compound. This is in line with animal welfare considerations because additional animal tests can be avoided by such an evaluation.
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Sanodal Gold 4N. The data indicate that there is no relevant dermal absorption. On the other hand, Sanodal Gold 4N is absorbed from the gastro-intestinal tract in toxicologically significant amounts. Metabolism via hydrolysis to form oxalic acid is considered probable. Indications of a bio-accumulative potential as well as a metabolism towards genotoxic sub-structures do not exist. Excretion of systemically available Sanodal Gold 4N and/or potential metabolites via the kidney can be assumed.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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