Volatile N-
nitrosamines have been found in rubber products including gloves, balloons, toys, baby bottle teats, soothers, and
condoms. N-
Nitrosamines are potent
carcinogens, and therefore, European legislation has limited the release of N-
nitrosamines and N-nitrosatable compounds in teats and soothers to 0.01-0.1 mg/kg rubber, respectively. Previously, endogenous
nitrosamine formation in the vagina has been suggested as a cause of
cervical cancer. It was speculated that exogenous N-
nitrosamines and N-nitrosatable compounds from
condoms may also lead to genital
cancer. Therefore, we reviewed the literature and calculated the risk for the induction of
tumors by
nitrosamines from
condoms. In vitro Biaudet et al. (1997) found up to 88 ng nitrosatable compounds migrating from
condoms to cervical mucous within 24 hrs. During sexual intercourse about 0.6 ng may migrate in the female genital mucous membranes because of the short contact to the
condom, e.g. 10 min. Comparable amounts of
nitrosamines may also migrate in the penile skin. Estimating 1500 contacts to
condoms during lifetime (50
condoms/year for 30 years) this may result in the adsorption of up to 0.9 microgram
nitrosamines in total. Animal studies in Syrian hamsters showed the induction of local and/or systemic
tumors, in particular liver
tumors, after topical application of
nitrosamines to the skin or mucous membrane at a total dose of about 1 g. This dose exceeds the dose to be expected from contact with
condoms by more than 1 million. Also, epidemiological studies do not support a role for
condoms in the induction of
cancer. The incidence of
cervical cancer and liver
tumors is high in developing countries, where
condoms are seldom used. In addition, humans are regularly exposed to
nitrosamines from food and tobacco
smoke at a dose which is 1,000 to 10,000 fold higher than expected from
condom use. In summary, the risk for the induction of
tumors from
nitrosamines in
condoms is very low.