title: Assessing the risk of type 1 allergy to enzymes present in laundry and cleaning products: evidence from the clinical data.
abstract: Microbial enzymes have been used in laundry detergent products for several decades. These enzymes have also long been known to have the potential to give rise to occupational type 1 allergic responses. A few cases of allergy among consumers using dusty enzyme detergents were reported in the early 1970s. Encapsulation of the enzymes along with other formula changes were made to ensure that consumer exposure levels were sufficiently low that the likelihood of either the induction of IgE antibody (sensitization) or the elicitation of clinical symptoms be highly improbable. Understanding the consumer exposure to enzymes which are used in laundry and cleaning products is a key step to the risk management process. Validation of the risk assessment conclusions and the risk management process only comes with practical experience and evidence from the marketplace. In the present work, clinical data from a range of sources collected over the past 40 years have been analysed. These include data from peer reviewed literature and enzyme specific IgE antibody test results in detergent manufacturers' employees and from clinical study subjects. In total, enzyme specific IgE antibody data were available on 15,765 individuals. There were 37 individuals with IgE antibody. The majority of these cases were from the 1970s where 23 of 4687 subjects (0.49%) were IgE positive and 15 of the 23 were reported to have symptoms of allergy. The remaining 14 cases were identified post-1977 for a prevalence of 0.126% (14/11,078). No symptoms were reported and no relationship to exposure to laundry and cleaning products was found. There was a significant difference between the pre- and post-1977 cohorts in that the higher rates of sensitization with symptoms were associated with higher exposure to enzyme. The clinical testing revealed that the prevalence of enzyme specific IgE in the population is very rare (0.126% since 1977). This demonstrates that exposure to these strong respiratory allergens via use of laundry and cleaning products does not lead to the development of sensitization and disease. These data confirm that the risk to consumers has been properly assessed and managed and support the concept that thresholds of exposure exist for respiratory allergy. Expansion of enzyme use into new consumer product categories should follow completion of robust risk assessments in order to continue ensuring the safe use of enzymes among consumers.
authors.affiliation: The Procter & Gamble Company, Cincinnati, OH, United States. Sarlo.k@pg.com <Sarlo.k@pg.com>
authors.forename: Katherine
authors.initials: K
authors.lastname: Sarlo
authors.forename: Donald B
authors.initials: DB
authors.lastname: Kirchner
authors.forename: Esperanza
authors.initials: E
authors.lastname: Troyano
authors.forename: Larry A
authors.initials: LA
authors.lastname: Smith
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Carr
authors.forename: Carlos
authors.initials: C
authors.lastname: Rodriguez
mesh_terms: D000485:Allergens / Q000276:immunology; D003902:Detergents / Q000737:chemistry*; D004391:Dust / Q000276:immunology; D006801:Humans; D006967:Hypersensitivity / Q000453:epidemiology* / Q000276:immunology*; D006968:Hypersensitivity, Delayed / Q000276:immunology*; D006969:Hypersensitivity, Immediate / Q000276:immunology*; D015995:Prevalence; D012306:Risk; D018570:Risk Assessment
chemical_list: D000485:Allergens; D003902:Detergents; D004391:Dust