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EC number: 233-653-7 | CAS number: 10294-26-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- In principle, the study results are well documented with one exception: histopathological effects are described only very briefly and it is not possible to evaluate whether the findings of bile duct hyperplasia in livers observed at all dose groups are of toxicological relevance.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Twenty-eight-day oral toxicity, genotoxicity, and gender-related tissue distribution of silver nanoparticles in Sprague-Dawely rats.
- Author:
- Kim, Y.S.; et al.
- Year:
- 2 008
- Bibliographic source:
- Inhalation Toxicology 20, 575-583
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Silver
- EC Number:
- 231-131-3
- EC Name:
- Silver
- Cas Number:
- 7440-22-4
- Molecular formula:
- Ag
- IUPAC Name:
- Silver
- Details on test material:
- - Name of test material (as cited in study report): silver nanoparticles
- Molecular formula (if other than submission substance): Ag
- Molecular weight (if other than submission substance): 107.87
- Physical state: solid
- Analytical purity: at least 99.98 % pure
- Other: silver nano particles (52.7 - 70.9 nm; average 60 nm), purchased form NAMATECH Co., Ltd. (Korea)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: OrientBio (Korea)
- Age at study initiation: 6 weeks old at start of exposure
- Weight at study initiation: about 283 g for the males and 192 g for the females
- Housing: polycarbonate cages (max. 3 rats per cage)
- Diet: rodent diet (Harlan Tek lab, Plaster International Co., Korea), ad libitum except before necropsy when food was withheld for 24 h
- Water: filtered water, ad libitum
- Acclimation period: 2 weeks before starting the experiment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23± 2 °C
- Humidity (%): 55 ± 7 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- aqueous, 0.5 % solution (from Sigma, USA)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: no details
VEHICLE
- Justification for use and choice of vehicle (if other than water): CMC is a standard vehicle in toxicity studies
- Amount of vehicle (if gavage): dosing volumes were 10 mL/kg - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
30 mg/kg/d (low dose)
Basis:
other: actual administered
- Remarks:
- Doses / Concentrations:
300 mg/kg/d (middle dose)
Basis:
other: actual administered
- Remarks:
- Doses / Concentrations:
1000 mg/kg/d (high dose)
Basis:
other: actual administered
- No. of animals per sex per dose:
- 10 male and 10 female rats per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: no data
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes, blood was drawn from the abdominal aorta
- Time schedule for collection of blood: after 28 days of exposure
- Anaesthetic used for blood collection: ether
- Animals fasted: for 24 hours
- How many animals: all
- Parameters checked: platelet counts, MPV, haemoglobin, haematocrit, RBC, WBC, MCV, MCH, MCHC, RDW, number of neutrophils, number of lymphocytes, numberof monocytes, number of eosinophils, percent of eosinophils, number of basophils, percent of basophils
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 28 days of exposure
- Animals fasted: for 24 hours
- How many animals: all
- Parameters checked: ALB, ALP, Ca, CHO, CRE, gamma-GT, GLU, GOT, GPT, inorg. phosphorus, LDH, Mg, total protein, uric acid, blood urea nitrogen, total bilirubin, creatine phosphokinase, Na, K, Cl, triglycerine, ratio of albumin to globulin
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- Before necropsy food was withheld for 24 hours. Rats were anesthetised with ether. After collection of blood rats were sacrificed by cervical dislocation.
GROSS PATHOLOGY: Yes
- The following organs were removed, weighed and fixed: adrenal glands, bladder, testes, ovaries, uterus, epididymis, seminal vesicle, heart, thymus, thyroid gland, trachea, esophagus, tongue, prostrate, lungs, nasal cavity, kidneys, spleen, liver, pancreas, and brain.
HISTOPATHOLOGY: Yes.
- The above mentioned organs were stained and examined under light microscope. - Other examinations:
- Silver distribution study:
- After wet digestion using a flameless method, the tissue concentration of silver was analysed by AAS. - Statistics:
- A multiple variance analysis and Duncan's multiple range tests were used to compare the body weights, organ weights, and results of the blood biochemistry and haematology for the three experimental groups with those of the fresh-air control rats. A value of p <0.05 indicated statistical significance.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- No distinct clinical signs were observed during the treatment period.
- No mortality occured.
BODY WEIGHT AND WEIGHT GAIN
- No significant changes of body weights were observed in male and female animals.
FOOD CONSUMPTION
- No significant differences were observed between treated and control animals.
HAEMATOLOGY
- In male rats, the mean corpuscular vlume (MCV) was significantly increased (p<0.05) in high dose males (1000 mg/kg bw/d) only.
- In female rats, red blood cells, hemoglobin and hematocrit were significantly increased (p<0.05) in mid and high dose animals (300, 1000 mg/kg bw/d).
- The active partial thromboplastine time (APTT) was significantly decreased (p<0.05) in high dose females.
CLINICAL CHEMISTRY
- Significantly increased levels of ALP were observed in high (1000 mg/kg bw/d) and mid dose (300 mg/kg bw/d) males (p<0.01 and 0.05, respectively) and high dose females (p<0.05).
- Cholesterol levels were increased in mid (not statistically significant) and high dose males (p<0.05) and mid and high dose females (p<0.01).
- Total protein was significantly decreased in high dose male rats (p<0.05).
ORGAN WEIGHTS
- No significant effects on organ weights were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
- Increesaed incidences of bile duct hyperplasia around the central vein were observed in livers of male and female animals in a dose-dependent way.
Effect levels
- Basis for effect level:
- other: no NOAEL identified; see details on results and conclusions in technical dossier
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Treatment of male and female rats with silver nanoparticles for 28 days revealed effects on red blood cell parameters at and above 300 mg/kg bw/d. Evidence of liver damage was observed by increases in alkaline phosphatase, cholesterol and total protein levels in mid and high dose animals treated with 300 or 1000 mg/kg bw/d. However, the information on histopathological findings is very limited, and it cannot be ruled out that bile duct hyperplasia in livers described already for low dose group animals are treatment-related. Thus, no NOAEL was defined based on the results of the study.
Silver deposits were observed dose-dependently in various organs of all treatment groups.
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