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1.
Regul Toxicol Pharmacol ; 146: 105527, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38056706

ABSTRACT

The Opinion of the Scientific Committee on Health, Environmental and Emerging Risks advises the European Commission on whether the uses of titanium dioxide in toys and toy materials can be considered to be safe in light of the identified exposure, and the classification of titanium dioxide as carcinogenic category 2 after inhalation. Four toy products including casting kits, chalk, powder paints and white colour pencils containing various amounts of TiO2 as colouring agent were evaluated for inhalation risks. For the oral route, childrens' lip gloss/lipstick, finger paint and white colour pencils were evaluated. When it can be demonstrated with high certainty that no ultrafine fraction is present in pigmentary TiO2 preparations used in toys and toy materials, safe use with no or negligible risk for all products considered is indicated based on the exposure estimations of this Opinion. However, if an ultrafine fraction is assumed to be present, safe use is not indicated, except for white colour pencils.


Subject(s)
Coloring Agents , Titanium , Child , Humans , Play and Playthings , Environmental Health
2.
Regul Toxicol Pharmacol ; 125: 104982, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34214611

ABSTRACT

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.


Subject(s)
Breast Implants/statistics & numerical data , Lymphoma, Large-Cell, Anaplastic/epidemiology , Causality , Humans , Risk Assessment , Risk Factors , Time Factors
3.
J Chem Phys ; 146(19): 194703, 2017 May 21.
Article in English | MEDLINE | ID: mdl-28527468

ABSTRACT

This paper presents a model, which we have designed to get insight into the development of electro-induced instability of a thin toluene emulsion film in contact with the saline aqueous phase. Molecular dynamics (MD) simulations demonstrate the role of charge accumulation in the toluene-film rupture induced by a DC electric field. Two ensembles-NVT and NPT-are used to determine the critical value of the external field at which the film ruptures, the charge distribution and capacitance of the thin film, number densities, and the film structure. The rupture mechanism as seen from this model is the following: in both NVT and NPT ensembles, condenser plates, where the charge density is maximal, are situated at the very border between the bulk aqueous (water) phase and the mixed layer. No ion penetration is observed within the toluene core, thus leaving all the distribution of charges within the mixed zone and the bulk phase that could be attributed to the formation of hydration shells. When the critical electric field is reached within a certain time after the field application, electric discharge occurs indicating the beginning of the rupturing process. The MD simulations indicate that the NPT ensemble predicts a value of the critical field that is closer to the experimental finding.

4.
Int J Pharm ; 509(1-2): 95-106, 2016 Jul 25.
Article in English | MEDLINE | ID: mdl-27184102

ABSTRACT

In recent years, nanotechnology has become increasingly important for global industries. Today, many nanomaterials are used as ingredients in cosmetics, food products, medical devices and pharmaceuticals. In some cases they exert unexpected risks and potentially pose a threat to human health and the environment. Regulatory authorities all over the world carefully observe recent developments in this area, striving to find a balance between consumer safety and the interests of the industry. In the following, the current legislation in the United States of America, the European Union, Asia and Brazil will be presented. Further, the requirements defined by these different authorities and methodology to investigate relevant characteristics of nanomaterials will be discussed.


Subject(s)
Global Health/legislation & jurisprudence , Nanostructures/adverse effects , Asia , Brazil , Consumer Product Safety/legislation & jurisprudence , European Union , Humans , Nanotechnology/legislation & jurisprudence , Nanotechnology/methods , United States
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