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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: little details reported, few animals, low maximal dose

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1989

Materials and methods

Principles of method if other than guideline:
Animals were injected 500 or 3000 µM Fe/kg bw (28 or 168 mg Fe/kg) and observed for 14 days. Control animals were sham-treated. Parameters: Mortality, observation, body weight, food consumption, necropsy
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Superparamagnetic iron oxide provided as an aqueous colloid with a concentration of 200 µM Fe/ml (11.2 mg/ml). The volume median diameter of particles was 80 nm (no data on composition or purity).


AMI 25 = superparamagnetic iron oxide provided as an aqueous colloid with a concentration of 200 µM Fe/ml (11.2 mg/ml). The volume median diameter of particles was 80 nm.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified

Administration / exposure

Route of administration:
intravenous
Vehicle:
not specified
Doses:
500 - 3000 µM Fe/ kg bw (28 - 168 mg Fe/kg bw)
No. of animals per sex per dose:
18
Control animals:
yes

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 168 mg/kg bw

Any other information on results incl. tables

Mortality: none
Body weight: no effect
Food consumption: no effect
Observation: no effects
Necropsy: no findings reported

Applicant's summary and conclusion

Conclusions:
No standard test method - no mortality occured, real LD50 probably much higher than maximum applied dose
Executive summary:
Animals were injected 500 or 3000 µM Fe/kg bw (28 or 168 mg Fe/kg) and observed for 14 days. No toxic effects were obseved.