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EC number: 243-957-1 | CAS number: 20667-12-3
- 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
Description of key information
Acute oral toxicity:
A reliable in-vivo acute toxicity study performed via oral route (OECD 401 – GLP) is available, solid powder of Ag2O (purity 93% of Ag) (Mayr, W et al. 1989). The study concluded that disilver oxide is not acute toxic via oral route. The LD50 was defined by the author at > 3804 mg/kg bw.
Acute inhalation toxicity:
The conduct of an acute inhalation study with disilver oxide is technically not feasible as shown in a feasibility test (Leuschner, 2010). Moreover, the study does not need to be conducted because exposure of humans via inhalation route is not likely to occur. The vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size limits the inhalation exposure.
Acute dermal toxicity:
The physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin (poorly water soluble). Moreover, the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 >3804 mg/kg bw) and no systemic effects have been observed in in-vivo studies with dermal exposure (nor skin irritant neither skin sensitizer).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-06-23 to 1989-07-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study. At the time of conduct, GLP was not compulsory. However, the study was conducted in accordance with the principles of GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Wistar Bor: WISW (SPFTNO)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co.KG, Borchen
- Age at study initiation: 7 - 8 weeks (males) and 9 - 10 weeks (females)
- Weight at study initiation: 132 - 189 g (males) and 138 - 167 g (females)
- Fasting period before study: 16 hours before treatment
- Housing: in Macrolon cages type II, individually housing
- Diet: ad libitum (standard diet, ssniff R, "Special Diet for Rats")
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 21
- Humidity (%): 50 - 65
- Photoperiod: 12 hours dark/light cycle - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: approx. 110, 162 and 237 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg - Doses:
- 2370 mg/kg body weight
3480 mg/kg body weight
5110 mg/kg body weight - No. of animals per sex per dose:
- 15 males and 15 females divided in 3 dosing groups, 5 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
The animals were continuously observed for the first 4 to 8 hours after administration and then once daily. The nature of the toxicity as well as the onset, the intensity and the duration of the signs were recorded.
Mortality was checkt twice daily. Time of death and number of dead animals per dose were documented.
The body weights were recorded at the beginning and also 7 and 14 days after administration or after death of the animals on days 2 to 14.
- Necropsy of survivors performed: yes; at the end of the observation period the animals were sacrificed with CO2.
Gross necropsy: was performed on all animals deceased intercurrently or sacrificed at the end of the observation period. Macroscopic examination included external appearance, body orifices, body cavities and their contents.
Histopathology: Samples of spleen and stomach were fixed in a 4% neutral buffered formaldehyde solution (10% formalin). The preserved tissues were trimmed, embedded in paraffin wax, sectioned at approximately 4 µm, stained with Hematoxylin and Eosin and examined microscopically. - Statistics:
- probit analysis
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 702 mg/kg bw
- 95% CL:
- 9.11
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 970 mg/kg bw
- 95% CL:
- 9.94
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 804 mg/kg bw
- 95% CL:
- 12.4
- Mortality:
- Deaths occurred 4 hours to 7 days after administration.
Mortality rates, males:
2370 mg/kg = 0%
3480 mg/kg = 20% (1 rat died on day 7 after exposure)
5110 mg/kg = 100% (2 animals died after 4 days and 6 days, respectively, and 1 rat died at day 5 after exposure)
Mortality rates, females:
2370 mg/kg = 0%
3480 mg/kg = 40% (1 rat died after 24 hours and another rats died on day 5 after exposure)
5110 mg/kg = 100% (2 animals died after 4 hours and 3 rats died after 2, 5 and 7 days after exposure, respectively) - Clinical signs:
- other: After administration of silver(I) oxide rats performed slight to severe hypokinesia, stilted gait, slight to moderate clonic convulsions, diarrhea, piloerection, sunken sides, cyanosis and strenuous respiration. In addition red nasal discharge and vocalis
- Gross pathology:
- At necropsy in deceased animals the forestomach was tightly filled, the glandular part was empty. The mucosa of glandular stomach and intestine was moderately to severly reddened. The small and large intestine contained yellow to black cloured mucous liquid. Additionally the spleen appeared small in two males. Sacrificed rats showed only thickening of the mucosa of the forestomach.
Microscopical examination revealed slight focal hyperkeratosis of the forestomach. In the glandular stomach focal submucosal edema, slight submucosal and mucosal mixed inflammatory cell infiltration and/or focal acute hemorrhages were found. The spleen exhibited slight to marked extramedullary hematopoiesis. In one intercurrently deceased male the spleen was markedly atrophic. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, silver(I) oxide, in the rat was found to be greater than 3804 mg/kg body weight. No symbol and risk phrase are required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 804 mg/kg bw
- Quality of whole database:
- good quality of the whole database
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
Reference
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- Justification for type of information:
- The physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin (poorly water soluble). Moreover, the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 >3804 mg/kg bw) and no systemic effects have been observed in in-vivo studies with dermal exposure (nor skin irritant neither skin sensitizer).
Reference
Additional information
Justification for classification or non-classification
A reliable study is available for acute oral toxicity of disilver oxide (rat, LD50 = 3804 mg/kg bw).
For disilver oxide, testing for acute inhalation is technically not feasible based on product characteristics (particles size, density) and coupled with the overall low systemic toxicity of silver substances, acute inhalation toxicity testing is not justified.
Acute dermal toxicity testing is not justified based on low overall systemic toxicity of silver compounds and low to negligible percutaneous absorption potential.
No hazard classification for acute toxicity is required for Ag2O.
Disilver oxide is not toxic after acute exposure via oral route. The inhalation acute toxicity study is technically not feasible and scientifically not necessary. The acute dermal
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