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Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
publication
Title:
Subchronic systemic toxicity and bioaccumulation of Fe3O4 nano- and microparticles following repeated intraperitoneal administration to rats
Author:
Katnelson et al.,
Year:
2011
Bibliographic source:
International Journal of Toxicology 30(1) 59-68

Materials and methods

Principles of method if other than guideline:
Aqueous suspensions of 10 nm, 50 nm, or 1 µm Fe3O4 particles were injected intraperitoneally (ip) to rats at a dose of 500 mg/kg in 4 mL of sterile deionized water 3 times a week for 5 weeks.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: nano-sized and micro-sized particles
Details on test material:
10, 50, and 1000 nm (1µm)

Test animals

Species:
rat
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Duration of treatment / exposure:
5 weeks
Frequency of treatment:
3 times a week for 5 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
500 mg/kg bw
No. of animals per sex per dose:
12 animals
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

It was found that, given equal mass doses, Fe3O4 nanoparticles possess considerably higher systemic toxicity than microparticles, but within the nanometric range the relationship between particle size and resorptive toxicity is intricate and nonunique. The latter fact may be attributed to differences in different nanoparticles’ toxicokinetics, which are controlled by both more or less substantial direct penetration of nanoparticles through biological barriers and their unequal solubility.

Applicant's summary and conclusion

Executive summary:

Aqueous suspensions of 10 nm, 50 nm, or 1 µm Fe3O4 particles were injected intraperitoneally (ip) to rats at a dose of 500 mg/kg in 4 mL of sterile deionized water 3 times a week for 5 weeks. Following exposure, functional and biochemical indices and histopathological examinations of spleen and liver tissues of exposed rats were evaluated for signs of toxicity. The iron content of the blood was measured photometrically, and that of the liver and the spleen by atomic adsorption spectroscopy (AAS) and electron paramagnetic resonance (EPR) methods. It was found that, given equal mass doses, Fe3O4 nanoparticles possess considerably higher systemic toxicity than microparticles, but within the nanometric range the relationship between particle size and resorptive toxicity is intricate and nonunique. The latter fact may be attributed to differences in different nanoparticles’ toxicokinetics, which are controlled by both more or less substantial direct penetration of nanoparticles through biological barriers and their unequal solubility.