International Agency for Research on Cancer (IARC) - Summaries & Evaluations


VOL.: 2 (1973) (p. 161)

CAS No.: 9004-66-4
Chem. Abstr. Name: Iron-dextran complex

CAS No.: 9004-51-7
Chem. Abstr. Name: Iron-dextrin complex

CAS No.: 1338-16-5
Chem. Abstr. Name: Iron-sorbitol-citric acid complex

CAS No.: 8047-67-4
Chem. Abstr. Name: Saccharated iron oxide

5. Summary of Data Reported and Evaluation

5.1 Animal carcinogenicity data

Repeated i.m. or s.c. injections of iron-dextran induced local sarcomas in the mouse, rat, rabbit and hamster; tests of relatively short duration in squirrel monkeys gave negative results. No conclusive evidence of tumour formation at sites distant from the injection site has been obtained in animals. It would appear that the carcinogenic activity of certain iron macromolecular complexes after i.m. or s.c. injections into rodents is a property of the complex itself, since neither the iron nor the carbohydrate component alone induces sarcomas. The severity of the early tissue changes at the injection site, which is increased by iron overloading, probably increases the risk of sarcoma development at that site.

Neither s.c. nor i.m. injections of iron-sorbitol-citric acid complex induce local sarcomas in rats or mice. It has been suggested that the negative results obtained with this complex are due to its more rapid removal from the injection site as compared with other iron macromolecular complexes which produce sarcomas. The Working Group noted that this compound could not be tested at higher doses than those employed, on account of the toxic effects produced.

Both iron-dextrin complex and saccharated iron oxide produce local sarcomas in mice after repeated s.c. injections. Iron-dextrin also produces local sarcomas in rats after repeated i.m. injections.

5.2 Human carcinogenicity data

Iron-dextran was first introduced for clinical use during the 1950s, and other iron macromolecular complexes intended for parenteral administration were introduced subsequently. A single case of sarcoma at the site of repeated injections of iron-dextran has been described, but it is not known if the sarcoma was caused by the treatment. There is no other evidence to suggest that any of these agents under conditions of clinical use constitute a risk of cancer in man. The period since the introduction of parenteral iron therapy may, however, be too brief for sarcomas to have developed. No epidemiological studies have been reported.

Subsequent evaluation: Suppl. 7 (1987) (p. 226: Iron-dextran complex - Group 2B); (p. 64: Iron-dextrin complex - Group 3, Iron-sorbitol-citric acid complex - Group 3; p. 71: Saccharated iron oxide - Group 3)

For definition of Groups, see Preamble Evaluation.

Synonyms for Iron-dextran complex

Synonyms for Iron-dextrin complex

Synonyms for Iron-sorbitol-citric acid complex

Synonyms for Saccharated iron oxide

Last updated: 16 March 1998

    See Also:
       Toxicological Abbreviations