Review on butylparaben: exposure, toxicity and risk assessment with a focus on endocrine disrupting properties and cumulative risk assessment

ABSTRACT - Butylparaben is used as a preservative because it inhibits the growth of fungi and bacteria in, for example, personal care products. However, butylparaben, just like other parabens, is suspected of having endocrine-disrupting properties or, to put it another way, of being an endocrine disruptor. Endocrine disruptors can compromise the hormonal system in the human body.

As yet, RIVM has been unable to determine whether butylparaben must actually be considered an endocrine disruptor. Because of the likely limited extent to which consumers are exposed to butylparaben and the information currently available about its effect on health, there does not appear to be any reason for concern. Additional research is needed to reduce any uncertainties in this conclusion.

Personal care products are the most significant source of the total calculated amount of butylparaben with which consumers come into contact. For safety's sake, this calculation is based on worst-case scenarios. There are also indications that such products are far less likely to contain parabens these days. There is no relevant information available for estimating exposure via medicines. Intake via food does not play a role in exposure because, among other reasons, butylparaben's use as an additive in foods or in food contact materials, such as packaging, is forbidden in Europe.

Many studies on the properties of butylparaben show that it has an endocrine-related action or suggest that it is an endocrine disruptor. Experts will have to discuss further whether the data in question yields sufficient evidence to actually classify butylparaben is an endocrine disruptor. They will test whether the substance meets the criteria recently drawn up for endocrine disruptors. Additional evidence may also be necessary.

The risk assessment of butylparaben entails uncertainties. It is highly likely that the current calculated exposure is higher than is actually the case and, moreover, it is possible that the differences between the effects on humans and the effects on laboratory animals are not being taken sufficiently into account.

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