Registration Dossier
Registration Dossier
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EC number: 232-076-8 | CAS number: 7785-23-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: reasonably well described study, according to GLP, with minor limitations: no positive control included, no signs of bone marrow toxicity observed, no analytical verification of silver in bone marrow , no individual raw data reported
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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Silver
- EC Number:
- 231-131-3
- EC Name:
- Silver
- Cas Number:
- 7440-22-4
- IUPAC Name:
- silver(1+)
- Details on test material:
- Silver nanoparticles (diameter 52.7-70.9 nm, average 60nm), purchased from NAMATECH Co. Ltd. (Korea). Purity at least 99.98%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5% carboxymethylcellulose
- Details on exposure:
- Dosing regimen: per gavage, daily for 28 days in total (in 0,5% carboxymethylcellulose)
- low-dose 30 mg/kg bw/day
- mid-dose 300 mg/kg bw/day
- high dose 1000 mg/kg bw/day
- negative (vehicle) control group included
- No. of animals per sex per dose:
- 10 m/f per group
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- Animals were sacrificed 24 after final dose; bone marrow smears from femur, acridine orange staining; 2000 polychromatic erythrocytes (PCEs) per animal werescored for micronuclei.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Additional information on results:
- The results of the study showed that silver nanoparticles did not affect either the frequency of micronucleated polychromatic erythrocytes, taken as an indicator of DNA damage, or the PCE/(PCE+NCE) ratio, an indicator of toxicity to bone marrow.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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