Abstract
Phthalates are diesters of phthalic acid and have been widely used as plasticizers in polyvinyl chloride (PVC) plastics. Phthalates are also used as excipients in pharmaceuticals and personal care products (PCPs). Phthalates can migrate from the plastic into the air, water and food, and humans can be exposed via multiple pathways such as dermal, oral and inhalation. There is evidence that phthalates can induce reproductive and developmental toxicity not only in experimental animals but also in humans through disruption of estrogenic activity. The aim of this study was to collect concentration data on five phthalates in foods and PCPs from the scientific literature and combine these with food consumption data and PCP use frequency data from the EuroMix biomonitoring (BM) study in order to assess exposure. Probabilistic exposure assessments of phthalates were performed from foods and PCPs. Due to the very limited data available in the literature for DINCH, an exposure assessment was not carried out for this compound. The food groups with the highest contribution to phthalates exposure were: beverages, dairy, bread and meat products. The exposure estimates were compared with the measured phthalate metabolite levels from 24-hour urine samples. Regarding the oral route, measured phthalate exposure was between the lower bound (LB) and medium bound (MB) estimated exposure for all phthalates, except for DEP. The measured exposure from urine correlated with the estimated exposure from food for DEHP and DBP, while for BBP and DEP it correlated with the exposure estimates from PCPs. There were no significant differences between the BM data and the estimated exposure, except for DINP for males (p = 0.01). The LB and MB phthalate exposures estimated from foods and PCPs and the measured exposure from the urine were considerably lower than their respective tolerable daily intake (TDI) values established by the European Food Safety Authority (EFSA) and the World Health Organization (WHO). For the upper bound (UB), the exposure estimates are approximately double the TDI; however, this is regarded as a worst-case estimate and has low correlation with the measured exposure.
Highlights
Phthalates are a group of several diesters of phthalic acid and have been widely used as plasticizers giving flexibility and durability to polyvinyl chloride (PVC) plastics
Di-2-ethylhexyl phthalate (DEHP), one of the most widely used phthalates, has been linked with liver carcinogenicity in rodents and was initially classified by the International Agency for Research on Cancer (IARC) as possibly carcinogenic in humans (Category 2B), but, in a more recent evaluation, DEHP was in the un classified group of compounds (Category 3) (IARC, 2013)
The estimates for the upper bound (UB) are significantly higher in our study, which can be attributed to a variety of factors such as: limited concentration data base, cases where only limited descriptive values were available, the addition of water to the beverages food group leading to high consumption values and very high exposure estimates when combined with the P95 concentration values used for the calculation of the UB
Summary
Phthalates are a group of several diesters of phthalic acid and have been widely used as plasticizers giving flexibility and durability to PVC plastics Their use commonly ranges from plasticizers in plastics, including food contact materials and toys, to emulsifying agents and Abbreviations: ABS, dermal absorption factor; B&A, Bland-Altman; BBP, butyl-benzyl-phthalate; BM, biomonitoring; BW, body weight; cx-MiNP, mono-4-methyl7-carboxyoctyl phthalate; DBP, di-n-butyl phthalate; DEHP, di (2-ethylhexyl) phthalate; DEP, diethyl phthalate; DiBP, Diisobutyl phthalate; DINCH, di(isononyl) cyclohexane-1,2-clicarboxylate; DINP, di-iso-nonyl phthalate; EFSA, European Food Safety Authority; HBGV, health-based guidance values; LB, lower bound; LOD, limit of detection; LOQ, limit of quantification; MB, medium bound; MBzP, monobenzyl phthalate; MECPP, mono-2-ethyl 5-carboxypentyl phthalate; MEHHP, mono2-ethyl-5-hydroxyhexyl phthalate; MEHP, mono-2-ethylhexyl phthalate; MEOHP, mono-2-ethyl-5-oxohexyl phthalate; MEP, monoethyl phthalate; MiBP, mono-isobutyl phthalate; MMCHP, mono-2-carboxymethyl hexyl phthalate; oh-MINCH, 2-(((hydroxy-4-methyloctyl)oxy)carbonyl)-cyclohexanecarboxylic acid; oh-MiNP, mono-4-methyl-7-hydroxyoctyl phthalate; oh-MPHP, 6-hydroxy monopropylheptylphthalate; oxo-MINCH, 2-(((4-Methyl-7-oxyooctyl)oxy)carbonyl)-cyclo hexanecarboxylic acid; oxo-MiNP, mono-4-methyl-7-oxooctyl phthalate; MnBP, mono-n-butyl phthalate; ND, non-detects; PCPs, personal care products; PVC, polyvinyl chloride; RPF, Relative Potency Factor; TDI, tolerable daily intake; TDS, total diet study; UB, upper bound; WHO, World Health Organization. In order to es timate human exposure to a chemical, concentration data in food and PCPs are needed, in addition to data on consumption, and use frequency
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