Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: not relevant - coated iron oxides were used in the studies

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1989
Reference Type:
publication
Title:
Unnamed
Year:
1991
Reference Type:
publication
Title:
Unnamed
Year:
1988
Reference Type:
publication
Title:
Unnamed
Year:
1995
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Study type:
clinical case study
Principles of method if other than guideline:
Superparamagnetic particles were used as contrast medium in MRI (Magnetic Resonance Imaging)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lönnemark et al. used polymeric particles coated with magnetite (Fe3O4) and gamma Fe2O3
Magin et al. used dextran coated iron oxide (magnetite)

Method

Subjects:
Humans and laboratory animals (rats)
Reason of exposure:
other: as contrast medium in MRI

Results and discussion

Applicant's summary and conclusion

Executive summary:

Magnetic iron oxides demonstrated a significantly increase in dectability of some

abdominal tumors by MR