18th list of substances for food contact materials - Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food

Aguilar, Fernando; Autrup, Herman; Barlow, Sue; Castle, Laurence; Crebelli, Riccardo; Dekant, W.; Engel, Karl‐Heinz; Gontard, Nathalie; Gott, David Michael; Grilli, Sandro; Guertler, R.; Larsen, John Christian; Leblanc, Jean‐Charles; Leclercq, Catherine; Malcata, F; Mennes, Wim; Milana, Maria Rosaria; Pratt, Iona; Rietjens, Ivonne M.C.M.; Tobback, Paul; Toldrá, Fidel

doi:10.2903/j.efsa.2008.628

Cited by 9 publications

(2 citation statements)

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“…Toxicological studies with DEHTP have not demonstrated any of the critical effects linked with DEHP toxicity (“phthalate syndrome”) ( Topping et al, 1987 ; Barber and Topping 1995 ; Gray Jr et al, 2000 ). A tolerable daily intake (TDI) of 1000 μg/kg bw/day based upon a 2-year rodent combined toxicity/carcinogenicity study was derived by the European Food Safety Authority (EFSA) in 2008 ( EFSA 2008 ). The TDI for DEHTP is a factor of 20 higher than the TDI for DEHP of 50 μg/kg bw/day ( EFSA 2005 ) and a factor of 50 higher than the reference dose (RfD) of 20 μg/kg bw/d for DEHP ( US EPA 1987 ).…”

Section: Introductionmentioning

confidence: 99%

Development, testing, parameterisation, and calibration of a human PBPK model for the plasticiser, di-(2-ethylhexyl) terephthalate (DEHTP) using in silico, in vitro and human biomonitoring data

McNally

Sams²,

Hogg³

et al. 2023

Front. Pharmacol.

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A physiologically based pharmacokinetic model for di-(2-ethylhexyl) terephthalate (DEHTP) based on a refined model for di-(2-propylheptyl) phthalate (DPHP) was developed to interpret the metabolism and biokinetics of DEHTP following a single oral dose of 50 mg to three male volunteers. In vitro and in silico methods were used to generate parameters for the model. For example, measured intrinsic hepatic clearance scaled from in vitro to in vivo and plasma unbound fraction and tissue:blood partition coefficients (PCs) were predicted algorithmically. Whereas the development and calibration of the DPHP model was based upon two data streams, blood concentrations of parent chemical and first metabolite and the urinary excretion of metabolites, the model for DEHTP was calibrated against a single data stream, the urinary excretion of metabolites. Despite the model form and structure being identical significant quantitative differences in lymphatic uptake between the models were observed. In contrast to DPHP the fraction of ingested DEHTP entering lymphatic circulation was much greater and of a similar magnitude to that entering the liver with evidence for the dual uptake mechanisms discernible in the urinary excretion data. Further, the absolute amounts absorbed by the study participants, were much higher for DEHTP relative to DPHP. The in silico algorithm for predicting protein binding performed poorly with an error of more than two orders of magnitude. The extent of plasma protein binding has important implications for the persistence of parent chemical in venous blood—inferences on the behaviour of this class of highly lipophilic chemicals, based on calculations of chemical properties, should be made with extreme caution. Attempting read across for this class of highly lipophilic chemicals should be undertaken with caution since basic adjustments to PCs and metabolism parameters would be insufficient, even when the structure of the model itself is appropriate. Therefore, validation of a model parameterized entirely with in vitro and in silico derived parameters would need to be calibrated against several human biomonitoring data streams to constitute a data rich source chemical to afford confidence for future evaluations of other similar chemicals using the read-across approach.

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Section: Introductionmentioning

confidence: 99%

Development, testing, parameterisation, and calibration of a human PBPK model for the plasticiser, di-(2-ethylhexyl) terephthalate (DEHTP) using in silico, in vitro and human biomonitoring data

McNally

Sams²,

Hogg³

et al. 2023

Front. Pharmacol.

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show abstract

“…Regarding BP, the average dietary exposure ranged from 0.744 µg/kg bw per day (pool 10-17 years) to 2.25 µg/kg bw per day (pool 12-35 months), in all cases, was lower than the TDI (0.03 mg/kg bw per day) specified by EFSA [6]. The estimated dietary exposure to DEHT was also below TDI (1 mg/kg bw) in all age groups [40]. For 1,3-DPP, the estimated dietary exposure ranged from 0.372 µg/kg bw per day (pool 10-17 years) to 1.13 µg/kg bw per day (pool 12-35 months).…”

Section: Migrants Concentration In Food and Dietary Exposure Estimationmentioning

confidence: 74%

Dietary Exposure Estimation to Chemicals Transferred from Milk and Dairy Products Packaging Materials in Spanish Child and Adolescent Population

Lestido‐Cardama

Sendón

Bustos³

et al. 2020

Foods

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Packaging materials are subject to risk assessment since they can transfer their components to the food, and they may constitute a risk for the consumers’ health. Therefore, estimating the exposure to chemicals migrating from packaging is required. In this study, a novel approach based on a total diet study (TDS)-like investigation to evaluate the exposure to chemicals transferred from the packaging was presented. The proposed methodology involved a non-targeted gas chromatography coupled to mass spectrometry (GC-MS) method to identify potential migrants and the determination of the migrants in composite food samples. The method was applied to evaluate the dietary exposure to chemicals from food packaging materials used for milk and dairy products in the Spanish child and adolescent populations. Several migrants identified in packaging materials were selected to determine their concentration in composite food samples. These chemicals included diethyl phthalate (DEP), diisobutyl phthalate (DIBP), dibutyl phthalate (DBP), bis(2ethylhexyl) phthalate (DEHP), benzophenone (BP), 1,3-diphenylpropane (1,3-DPP), and bis(2-ethylhexyl) terephthalate (DEHT). The method exhibited a good sensitivity (limit of detection, LOD ≤ 0.05 µg/g) and a satisfactory recovery (78.4-124%). Finally, the exposure was estimated using the Spanish national dietary survey ENALIA. Phthalates DBP and DEHP showed the highest mean exposure, ranging from 2.42 (10–17 years)–4.40 (12–35 months) and 1.35 (10–17 years)–4.07 (12–35 months) µg/kg bw/day for DBP and DEHP, respectively.

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Exposure to 15 phthalates and two substitutes (DEHTP and DINCH) assessed in trios of infants and their parents as well as longitudinally in infants exclusively breastfed and after the introduction of a mixed diet

Frederiksen

Upners

Ljubicic

et al. 2022

Environment International

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18th list of substances for food contact materials - Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food

Cited by 9 publications

References 0 publications

Development, testing, parameterisation, and calibration of a human PBPK model for the plasticiser, di-(2-ethylhexyl) terephthalate (DEHTP) using in silico, in vitro and human biomonitoring data

Development, testing, parameterisation, and calibration of a human PBPK model for the plasticiser, di-(2-ethylhexyl) terephthalate (DEHTP) using in silico, in vitro and human biomonitoring data

Dietary Exposure Estimation to Chemicals Transferred from Milk and Dairy Products Packaging Materials in Spanish Child and Adolescent Population

Exposure to 15 phthalates and two substitutes (DEHTP and DINCH) assessed in trios of infants and their parents as well as longitudinally in infants exclusively breastfed and after the introduction of a mixed diet

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