Canavez Andrezza Di Pietro Micali, de Oliveira Prado Corrêa Gabriela, Isaac Vera Lucia Borges, Schuck Desiree Cigaran, Lorencini Marcio
Department of Safety Assessment, Grupo Boticário, São José dos Pinhais, PR, Brazil.
School of Pharmaceutical Sciences, UNESP - Univ Estadual Paulista, Araraquara, SP, Brazil.
J Appl Toxicol. 2021 Oct;41(10):1687-1699. doi: 10.1002/jat.4156. Epub 2021 Feb 24.
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.
化妆品的安全性评估基于成分的安全性，这需要有关化学结构、毒理学特征和暴露数据的信息。约6%的人群对化妆品成分敏感，尤其是防腐剂和香料。在此背景下，本研究的目的是对苯扎氯铵（BAC）、苯甲醇（BA）、辛酰二醇（CG）、乙基己基甘油（EG）、氯苯甘醚（CP）、脱氢乙酸（DHA）、脱氢乙酸钠（SDH）、碘丙炔醇丁基氨甲酸酯（IPBC）、甲基氯异噻唑啉酮和甲基异噻唑啉酮（MCI/MIT）、甲基异噻唑啉酮（MIT）、苯氧乙醇（PE）、山梨酸钾（PS）和苯甲酸钠（SB）进行危害评估和风险特征描述。基于已发表的安全报告，将测试和评估的综合方法（IATA）和证据权重（WoE）视为决策树。危害评估由一个毒理学矩阵组成，该矩阵将毒性水平定义为低（L）、中（M）或高（H），并考虑皮肤致敏、皮肤刺激、眼睛刺激、光毒性、急性口服毒性、致癌性、诱变性/遗传毒性和内分泌活性等终点，关联局部或全身暴露情况。在风险评估方法中，考虑最坏情况（100%皮肤吸收）时，除DHA、SDH和EG外，大多数防腐剂的安全边际（MoS）高于100。然而，孤立的数据无法建立安全性评估。有必要基于产品中的浓度、使用频率、产品类型、暴露途径、体表位置和目标人群，考虑危害和暴露评估进行合理的风险特征描述，以估计不良健康后果的风险水平。
