Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives

Abstract

The safety assessment of cosmetic products is based on the safety of the ingredients, which requires information on chemical structures, toxicological profiles, and exposure data. Approximately 6% of the population is sensitized to cosmetic ingredients, especially preservatives and fragrances. In this context, the aim of this study was to perform a hazard assessment and risk characterization of benzalkonium chloride (BAC), benzyl alcohol (BA), caprylyl glycol (CG), ethylhexylglycerin (EG), chlorphenesin (CP), dehydroacetic acid (DHA), sodium dehydroacetate (SDH), iodopropynyl butylcarbamate (IPBC), methylchloroisothiazolinone and methylisothiazolinone (MCI/MIT), methylisothiazolinone (MIT), phenoxyethanol (PE), potassium sorbate (PS), and sodium benzoate (SB). Considering the integrated approaches to testing and assessment (IATA) and weight of evidence (WoE) as a decision tree, based on published safety reports. The hazard assessment was composed of a toxicological matrix correlating the toxicity level, defined as low (L), moderate (M), or high (H) and local or systemic exposure, considering the endpoints of skin sensitization, skin irritation, eye irritation, phototoxicity, acute oral toxicity, carcinogenicity, mutagenicity/genotoxicity, and endocrine activity. In a risk assessment approach, most preservatives had a margin of safety (MoS) above 100, except for DHA, SDH, and EG, considering the worst‐case scenario (100% dermal absorption). However, isolated data do not set up a safety assessment. It is necessary to carry out a rational risk characterization considering hazard and exposure assessment to estimate the level of risk of an adverse health outcome, based on the concentration in a product, frequency of use, type of product, route of exposure, body surface location, and target population.

The application of non-oxidizing biocides to prevent biofouling in reverse osmosis polyamide membrane systems: a review

“…The researchers also reported that the Kathon biocide (400 mg/L) did not present dermal carcinogenic effects in mice in a 30 months experiment. Similar results were reported by Burnett et al (2010) and Canavez et al (2021).…”

“…Besides skin irritation and allergies, human exposure to isothiazolinone biocides might cause respiratory problems (Bourke et al 1997;Lee et al 2018;Silva et al 2020). Regarding the carcinogenic risk of MIT, recent studies show that MIT is not carcinogenic (Burnett et al 2010;Canavez et al 2021). assessed the potential risks to human health of the CMIT/MIT biocide (Kathon™ brand).…”

“…2-phenoxyethanol has a large spectrum of antimicrobial activity and is effective against Gram-negative, Gram-positive, molds, and yeast (Dréno et al 2019;Canavez et al 2021). It is noted that PE is more effective against Gram-positive than Gram-negative bacteria (Paulus 2005).…”

Enzyme-treated chicory for cosmetics: application assessment and techno-economic analysis

“…Microbial contamination in cosmetic products can lead to changes in the structure that are perceived as differences in viscosity, color and odor. However, ~ 6% of the population is sensitized to cosmetic ingredients, especially preservatives and fragrances (Canavez et al 2021 ). Preservatives may cause skin irritation, erythema, contact allergy, contact sensitization, and contact dermatitis (Halla et al 2018 ).…”

An overview of current alternative models in the context of ocular surface toxicity

“…Since 2013, in Europe, the cosmetic industry has been confronted with strict prohibition of evaluating its products on animals. Integrated approaches of testing and assessment (IATA), promoted by the OECD (Organisation for Economic Cooperation and Development), might enable validation of new compounds in this sector (Canavez et al, 2021).…”