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Diss Factsheets

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:
2008
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

Constituent 1
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%.

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