Update of the risk assessment of ‘wood flour and fibres, untreated’ (FCM No 96) for use in food contact materials, and criteria for future applications of materials from plant origin as additives for plastic food contact materials

Silano, Vittorio; Baviera, José Manuel Barat; Bolognesi, Claudia; Chesson, Andrew; Cocconcelli, Pier Sandro; Crebelli, Riccardo; Gott, David Michael; Grob, Konrad; Lampi, Evgenia; Mortensen, Alicja; Steffensen, Inger‐Lise; Tlustos, Christina; Loveren, Henk Van; Vernis, Laurence; Zorn, Holger; Castle, Laurence; Consiglio, Emma Di; Franz, Roland; Hellwig, Nicole; Milana, Maria Rosaria; Pfaff, Karla; Volk, Katharina; Rivière, Gilles

doi:10.2903/j.efsa.2019.5902

Cited by 6 publications

(4 citation statements)

References 5 publications

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“…Each experiment included 4–6 mice in each group, and each experiment was independently repeated 2–4 times. The mice were orally fed BBP (Sigma-Aldrich, St. Louis, MO, USA) daily to mimic human exposure based on the human tolerable daily intake (TDI) dose of 0.5 mg/kg body weight (BW)/day, as determined by the European Food Safety Authority [ 22 ], or were fed a 3-fold TDI dose, that is, 1.5 mg/kg BW/day. Before endometriosis induction by surgery, animals were orally fed BBP for 10 days, with surgery for endometriosis induction occurring on Day 11.…”

Section: Methodsmentioning

confidence: 99%

n-Butyl Benzyl Phthalate Exposure Promotes Lesion Survival in a Murine Endometriosis Model

Sharma

Lee

Tsai

et al. 2021

IJERPH

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Endometriosis is an inflammatory and estrogen-dependent gynecological disease associated with exposure to environmental endocrine disruptors. n-Butyl benzyl phthalate (BBP), a ubiquitous plasticizer, has weak estrogenic activity, and exposure to BBP is associated with endometriosis. We aimed to elucidate the immunomodulatory effect of BBP on endometriosis development. We previously established a surgery-induced endometriosis-like murine model. In the present study, we exposed those mice to BBP 10 days prior to surgery and 4 weeks after surgery at physiologically relevant doses to mimic human exposure. Chronic exposure to BBP did not promote the growth of endometriotic lesions; however, the lesion survival rate in BBP-treated mice did increase significantly compared with control mice. Multiparametric flow cytometry showed that BBP exposure did not affect the homeostasis of infiltrated immune subsets in lesions but did enhance CD44 (adhesion marker) expression on plasmacytoid dendritic cells (pDCs). Blocking CD44 interactions locally inhibited endometriotic lesion growth. Immunofluorescence results further confirmed that CD44 blocking inhibited pDC infiltration and reduced the frequency of CD44+ pDCs in endometriotic tissues. BBP also disrupted the estrus cycle in these mice. This study suggests that chronic exposure to low-dose BBP may promote survival of endometriotic tissue through CD44-expressing pDCs.

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Section: Methodsmentioning

confidence: 99%

n-Butyl Benzyl Phthalate Exposure Promotes Lesion Survival in a Murine Endometriosis Model

Sharma

Lee

Tsai

et al. 2021

IJERPH

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“…The control group was treated with the same volume of vehicle (corn oil). The exposure dosages in this study were designed according to the individual tolerable daily intakes (TDIs) and the possible occupational exposure levels of BBP reported in previous studies (Hines et al, 2011;Silano et al, 2019b). Body weight was quanti ed every three days.…”

Section: Animals and Treatmentsmentioning

confidence: 99%

Butyl benzyl phthalate as a key component of phthalate ester in relation to cognitive impairment in NHANES elderly individuals and experimental mice

Wang

Dong

et al. 2023

Environ Sci Pollut Res

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Phthalates are a group of neurotoxicants with cognitive-disrupting potentials. Given the structural diversity of phthalates, the corresponding neurotoxicity is dramatically altered. To identify the potential contributions of different phthalates on the process of cognitive impairment, data of 836 elders from the NHANES 2011-2014 cycles were used. Survey-weighted logistic regression and principal component analysis-weighted quantile sum regression (PCA-WQSR) models were applied to estimate the independent and combined associations of 11 urinary phthalate metabolites with cognitive de cit [assessed by 4 tests: Immediate Recall (IR), Delayed Recall (DR), Animal Fluency (AF), and Digit Symbol Substitution test (DSST] and to identify the potential phthalate with high weight. Laboratory mice were further used to examine the effect of phthalates on cognitive function and to explore the potential mechanisms. In logistic regression models, MBzP was the only metabolite positively correlated with four tests, with ORs of 2.53 [quartile 3 (Q3)], 2.26 (Q3), 2.89 (Q4) and 2.45 (Q2), 2.82 (Q4) for IR, DR, AF and DSST respectively. In PCA-WQSR co-exposure models, low-molecular-weight (LMW) phthalates were the only PC positively linked to DSST de cit (OR: 1.93), which was further validated in WQSR analysis (WQS OR 7 − phthalates : 1.56 and WQS OR 8 − phthalates : 1.55); consistent with the results of logistic regression, MBzP was the dominant phthalate. In mice, butyl benzyl phthalate (BBP), the parent phthalate of MBzP, dose-dependently reduced cognitive function and disrupted hippocampal neurons. Additionally, the hippocampal transcriptome analysis identi ed 431 differential expression genes, among which most were involved in inhibiting the neuroactive ligand-receptor interaction pathway and activating the cytokine-cytokine receptor interaction pathway. Our study indicates the critical role of BBP in the association of phthalates and cognitive de cits among elderly individuals, which might be speculated that BBP could disrupt hippocampal neurons, activate neuroin ammation and inhibit neuroactive receptors. Our ndings provide new insight into the cognitive-disrupting potential of BBP.

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“…96 (CAS 65996‐61‐4) without restrictions. However, a recent EFSA opinion (EFSA CEP Panel, 2019 ) stated that ‘there is insufficient information to support that the current authorisation of ‘wood flour and fibres, untreated’ is still in accordance with Regulation (EC) No 1935/2004’.…”

Section: Assessmentmentioning

confidence: 99%

Safety assessment of bleached cellulose pulp for use in plastic food contact materials

Lambré¹,

Baviera²,

Bolognesi³

et al. 2022

EFS2

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The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids assessed the safety of the substance bleached cellulose pulp, consisting of cellulose fibres (70–92%) and hemicellulose (8–30%) obtained from pine and spruce wood. The substance is intended to be used ■■■■■ in polyethylene and polypropylene food contact materials. The final articles are intended to be used for all food types and for long‐term storage at room temperature, with or without a short time at higher temperature, including hot‐fill. Low‐density polyethylene samples containing ■■■■■ of the substance were subjected to a broad set of migration tests with food simulants and extraction tests with dichloromethane. The limits of detection ranged from ■■■■■ (when specified). The Panel noted that they do not ensure the detection of genotoxic substances at a concentration leading to a human exposure above the Threshold of Toxicological Concern. Moreover, not all possibly migrating substances were identified or amenable to the analytical methods applied. No toxicological data were provided for the substance itself, as its migration into food is not expected. The safety of the potentially migrating substances of low molecular mass detected was addressed individually and was considered adequate. However, the Panel considered this approach insufficient owing to a substantial fraction of unidentified components. The Panel concluded that the information provided by the applicant does not allow the safety assessment of the substances below 1,000 Da from bleached cellulose pulp from pine and spruce wood used in plastic food contact materials potentially migrating into food. Therefore, the Panel could not conclude on the safety of the use of bleached cellulose pulp from pine and spruce wood as a plastic additive.

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Update of the risk assessment of ‘wood flour and fibres, untreated’ (FCM No 96) for use in food contact materials, and criteria for future applications of materials from plant origin as additives for plastic food contact materials

Cited by 6 publications

References 5 publications

n-Butyl Benzyl Phthalate Exposure Promotes Lesion Survival in a Murine Endometriosis Model

n-Butyl Benzyl Phthalate Exposure Promotes Lesion Survival in a Murine Endometriosis Model

Butyl benzyl phthalate as a key component of phthalate ester in relation to cognitive impairment in NHANES elderly individuals and experimental mice

Safety assessment of bleached cellulose pulp for use in plastic food contact materials

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