Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
Endpoint summary
Administrative data
Description of key information
Additional information
(Q)SAR models are indicating a possible risk for respiratory sensitisation of chlorhexidine digluconate, but there is at present no generally accepted tool/model available for this specific endpoint and the predictions in general are contradictory to human and in vitro data. Only extremely rare cases concerning possible respiratory sensitisation in humans caused by chlorhexidine digluconate have been described in the literature. Furthermore, experimental in vitro studies such as the Peroxidase Peptide Reactivity Assay or the Direct Peptide Reactivity Assay gave no indication for respiratory sensitising properties.
The toxicological properties of this substance have been extensively investigated in the past and recently also for the notification according to the BPR for its use as a biocidal active substance in different product types. Chlorhexidine digluconate is also on the essential medicines list of the WHO (e.g. in cases of umbilical cord care in newborn) and is used since decades in human and veterinary drug products.
Chlorhexidine digluconate has been widely used for more than 50 years as hand and skin disinfectant, in cosmetic products and for oral care in millions of consumers. For oral care products, such as mouthwashs, a droplet formation and potential aspiration during use has to be expected. Due to this, contact with the epithelial layer of the respiratory tract is very likely, but up to now no indications for sensitising properties of chlorhexidine digluconate in this regard are known.
Regarding the relevance of human data the REACH guidance "Guidance on Information Requirements and Chemical Safety Assessment R.7a (chapter 7.3.4.2 Human data on skin sensitization) defines the following requirements: "Ultimately, where a very large number of individuals (e.g. 10E+5) have frequent (daily) skin exposure for at least two years and there is an active system in place to pick up complaints and adverse reaction reports (including via dermatology clinics), and where no or only a very few isolated cases of allergic contact dermatitis are observed then the substance is unlikely to be a significant skin sensitizer. However, information from other sources should also be considered in making a judgement on the substance's ability to induce skin sensitisation." As the complexity of the induction of respiratory sensitization is similar to skin sensitization, the above stated requirements for the relevance of human data are also applicable for respiratory sensitisation. Even more in the absence of a reliable test system for respiratory sensitisation. Therefore, in the case of chlorhexidine digluconate the data base does not fulfil the requirements stated above.
In total it can be concluded that based on the long-term experience during production and handling of chlorhexidine digluconate at workplaces and also on the widespread and worldwide use over several decades as an active pharmaceutical ingredient (API) and biocidal active substance, a relevant risk for respiratory sensitisation in humans is not evident.
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