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

(Group 3)

For definition of Groups, see Preamble Evaluation.

VOL.: 50 (1990) (p. 153)

: 69-53-4

Ampicillin trihydrate
CAS No.: 7177-48-2

Ampicillin sodium salt
CAS No.: 69-52-3

5. Summary of Data Reported and Evaluation

5.1 Exposure data

Ampicillin is a broad-spectrum antibiotic and has been used extensively to treat bacterial infections since 1961.

5.2 Experimental carcinogenicity data

Ampicillin was tested for carcinogenicity by oral administration in mice and rats. It increased the incidences of mononuclear-cell leukaemia and of phaeochromocytomas of the adrenal medulla in male rats. A slight increase in the incidence of benign lung tumours was observed in female mice.

5.3 Human carcinogenicity data

In a hypothesis-generating cohort study, use of ampicillin was associated with the occurrence of lung and skin cancers, but these findings could have been due to chance.

5.4 Other relevant data

Use of ampicillin during the first trimester of pregnancy has not been associated with an increase in the incidence of major congenital malformations.

Ampicillin increased the frequency of chromosomal aberrations in human lymphocytes but not in human fibroblasts in vitro. It did not induce chromosomal aberrations in Chinese hamster cells, mutations in mouse lymphoma cells or sister chromatid exchange in human lymphocytes or in Chinese hamster cells. Ampicillin induced chromosomal aberrations in Vicia faba. It was not mutagenic to Salmonella typhimurium and did not induce differential toxicity in Escherichia coli strains.

5.5 Evaluation

There is inadequate evidence for the carcinogenicity of ampicillin in humans.

There is limited evidence for the carcinogenicity of ampicillin in experimental animals.

Overall evaluation

Ampicillin is not classifiable as to its carcinogenicity to humans (Group 3).

For definition of the italicized terms, see Preamble Evaluation.

Synonyms for Ampicillin

Synonyms for Ampicillin trihydrate

Synonyms for Ampicillin sodium salt

Synonyms for Ampicillin [mixture of tetrahydrate and sodium salt]

Last updated: 11 November 1997

    See Also:
       Toxicological Abbreviations