Ribavirin

In the present report the Health Council of the Netherlands reviewed ribavirin. Ribavirin is an antiviral drug, active against DNA and RNA viruses. This report is part of a series, in which the Health Council evaluates the effects of substances on reproduction, at request of the Minister of Social affairs and Employment. It mainly concerns substances to which man can be occupationally exposed. The Subcommittee on the Classification of Reproduction toxic substances of the Dutch Expert Committee on Occupational Safety of the Health Council, hereafter called the committee, evaluates the effects on male and female fertility and on the development of the progeny. Moreover, the effects of exposure on lactation are considered.

According to the Directive 93/21/EEC of the European Union, the committee recommends a classification. The committee’s recommendations for ribavirin are:

• For effects on fertility, the committee is of the opinion that due to a lack of appropriate data ribavirin should not be classified.
• For developmental toxicity, the committee recommends classifying ribavirin in category 3 (substances which cause concern for humans owing to possible developmental toxic effects) and to label ribavirin with Xn; R63.
• For effects during lactation, the committee is of the opinion that due to a lack of appropriate data ribavirin should not be labeled.