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Book ; Online: < > development and evaluation of a probabilistic model for aggregate exposure assessment to chemicals in cosmetics and personal care products

Dudzina, Tatsiana

2014

Abstract: Diss., Eidgenössische Technische Hochschule ETH Zürich, Nr. ... ...

Abstract	Diss., Eidgenössische Technische Hochschule ETH Zürich, Nr. 22314
Keywords	TOILETTENARTIKEL + KOSMETIKA ; CHEMISCHE ZUSAMMENSETZUNG CHEMISCHER PRODUKTE ; TOXIKOLOGIE ; EXPOSITIONSBESTIMMUNG + EXPOSITIONSBEWERTUNG (UMWELTMEDIZIN UND GEWERBEHYGIENE) ; STATISTISCHE UND MATHEMATISCHE METHODEN (TOXIKOLOGIE)
Language	English
Publisher	Zürich, ETH-Zürich
Publishing country	ch
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Thesis ; Online: The Development and Evaluation of a Probabilistic Model for Aggregate Exposure Assessment to Chemicals in Cosmetics and Personal Care Products

Dudzina, Tatsiana

2014

Keywords	TOILETTENARTIKEL + KOSMETIKA ; CHEMISCHE ZUSAMMENSETZUNG CHEMISCHER PRODUKTE ; EXPOSURE ASSESSMENT + EXPOSURE EVALUATION (ENVIRONMENTAL HEALTH AND OCCUPATIONAL HYGIENE) ; COSMETICS + TOILETRIES ; TOXIKOLOGIE ; STATISTISCHE UND MATHEMATISCHE METHODEN (TOXIKOLOGIE) ; STATISTICAL AND MATHEMATICAL METHODS (TOXICOLOGY) ; TOXICOLOGY ; CHEMICAL COMPOSITION OF CHEMICAL PRODUCTS ; EXPOSITIONSBESTIMMUNG + EXPOSITIONSBEWERTUNG (UMWELTMEDIZIN UND GEWERBEHYGIENE) ; info:eu-repo/classification/ddc/660 ; info:eu-repo/classification/ddc/610 ; Chemical engineering ; Medical sciences ; medicine
Language	English
Publisher	ETH Zurich
Publishing country	ch
Document type	Thesis ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: An assessment of the ECETOC TRA Consumer tool performance as a screening level tool.

Zaleski, Rosemary T / Dudzina, Tatsiana / Keller, Detlef / Money, Chris / Qian, Hua / Rodriguez, Carlos / Schnöder, Frank

Journal of exposure science & environmental epidemiology

2023 Volume 33, Issue 6, Page(s) 980–993

Abstract: Background: The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Targeted Risk Assessment (TRA) Consumer tool was developed to fill in a methodology gap for a high throughput, screening level tool to support industry compliance ... ...

Abstract	Background: The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Targeted Risk Assessment (TRA) Consumer tool was developed to fill in a methodology gap for a high throughput, screening level tool to support industry compliance with the European Union's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation. Objective: To evaluate if the TRA Consumer tool has met its design of being a screening level tool (i.e., one which does not under-predict potential exposures). Methods: The TRA Consumer tool algorithms and defaults were reviewed and performance benchmarked vs. other consumer models and/or empirical data. Findings from existing reviews of the TRA consumer tool were also considered and addressed. Results: TRA predictions based on its default inputs exceeded measured exposures when available, typically by orders of magnitude, and were generally greater than or similar to those of other consumer exposure tools. For dermal exposure from articles, there was no evidence that a diffusivity approach would provide more appropriate exposure estimates than those of the TRA. When default values are refined using more specific data, the refined values must be considered holistically to reflect the situation being modeled as some parameters may be correlated. Significance: This is the first evaluation of the ECETOC TRA consumer tool in its entirety, considering algorithms, input defaults, and associated predictions for consumer products and articles. The evaluation confirmed its design as a screening level tool. Impact statement: The ECETOC TRA Consumer tool has been widely applied to generate exposure estimates to support chemical registrations under the EU REACH regulation. This evaluation supports the appropriateness of the TRA as a screening level exposure assessment tool. It also warrants additional measurements of consumer exposure, especially for article use scenarios, to aid the development of consumer exposure tools and chemical risk assessment.
MeSH term(s)	Humans ; Ecotoxicology ; Occupational Exposure/analysis ; Algorithms ; Risk Assessment/methods ; Industry
Language	English
Publishing date	2023-01-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2218551-3
ISSN	1559-064X ; 1559-0631
ISSN (online)	1559-064X
ISSN	1559-0631
DOI	10.1038/s41370-022-00510-0
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Article ; Online: A framework for chemical safety assessment incorporating new approach methodologies within REACH.

Ball, Nicholas / Bars, Remi / Botham, Philip A / Cuciureanu, Andreea / Cronin, Mark T D / Doe, John E / Dudzina, Tatsiana / Gant, Timothy W / Leist, Marcel / van Ravenzwaay, Bennard

Archives of toxicology

2022 Volume 96, Issue 3, Page(s) 743–766

Abstract: The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety ... ...

Abstract	The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety of chemicals. However, this methodology is being adopted very slowly for regulatory purposes. Here, we have developed a framework incorporating in silico, in vitro and in vivo methods designed to meet the requirements of REACH in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers. We have exemplified the use of the framework with three examples. The outputs were the same or more conservative than parallel assessments based on conventional studies. The framework allows a transparent and phased introduction of NAMs in chemical safety assessment and enables science-based safety decisions which provide the same level of public health protection using fewer animals, taking less time, and using less financial and expert resource. Furthermore, it would also allow new methods to be incorporated as they develop through continuous selective evolution rather than periodic revolution.
MeSH term(s)	Animal Testing Alternatives ; Animals ; Chemical Safety/legislation & jurisprudence ; Chemical Safety/methods ; Computer Simulation ; Environmental Exposure/prevention & control ; Humans ; Risk Assessment/legislation & jurisprudence ; Risk Assessment/methods ; Toxicity Tests/methods
Language	English
Publishing date	2022-02-01
Publishing country	Germany
Document type	Journal Article
ZDB-ID	124992-7
ISSN	1432-0738 ; 0340-5761
ISSN (online)	1432-0738
ISSN	0340-5761
DOI	10.1007/s00204-021-03215-9
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Article ; Online: The European exposure science strategy 2020-2030.

Fantke, Peter / Bruinen de Bruin, Yuri / Schlüter, Urs / Connolly, Alison / Bessems, Jos / Kephalopoulos, Stylianos / Zare Jeddi, Maryam / van Nieuwenhuyse, An / Dudzina, Tatsiana / Scheepers, Paul T J / von Goetz, Natalie

Environment international

2022 Volume 170, Page(s) 107555

Abstract: Exposure science is an emerging and rapidly growing field dedicated to all aspects concerning the contact between chemical, biological, physical or psycho-social stressors and human and ecological receptors. With that, exposure science plays a central ... ...

Abstract	Exposure science is an emerging and rapidly growing field dedicated to all aspects concerning the contact between chemical, biological, physical or psycho-social stressors and human and ecological receptors. With that, exposure science plays a central role in protecting human and ecosystem health, and contributes to the global transition towards a green and sustainable society. In Europe, however, exposure science is currently not sufficiently recognised as a scientific field, resulting in inefficient uptake into policies. In response, the wider European exposure science community developed elements and actions under the auspices of the Europe Regional Chapter of the International Society of Exposure Science (ISES Europe), for identified priority areas, namely education, exposure models, exposure data, human biomonitoring, and policy uptake. In the present document, we synthesize these strategic elements into an overarching 'European Exposure Science Strategy 2020-2030', following three strategic objectives that focus on acknowledging exposure science as an independent and interconnected field, harmonizing approaches and tools across regulations, and exploring collaboration, education and funding mechanisms. To operationalise this strategy, we present concrete key actions and propose initiatives and funding options for advancing the underlying science, cultivating broader education and cross-sector exposure knowledge transfer, and fostering effective uptake of exposure information into policy. We aim at anchoring European efforts in the global exposure science context, with a special focus on the interface between scientific advancements, application in decision support, and dissemination and training. This will help to develop exposure science as a strong scientific field with the ultimate goal to successfully assess and manage various stressors across sectors and geographic scales.
MeSH term(s)	Humans ; Ecosystem ; Europe ; European Union
Language	English
Publishing date	2022-09-30
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	554791-x
ISSN	1873-6750 ; 0160-4120
ISSN (online)	1873-6750
ISSN	0160-4120
DOI	10.1016/j.envint.2022.107555
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Article ; Online: The European exposure science strategy 2020–2030

Fantke, Peter / Bruinen De Bruin, Yuri / Schlüter, Urs / Connolly, Alison / Bessems, Jos / Kephalopoulos, Stylianos / Zare Jeddi, Maryam / van Nieuwenhuyse, An / Dudzina, Tatsiana / Scheepers, Paul T.J. / von Götz, Natalie

Environment International, 170

2022

Abstract	Exposure science is an emerging and rapidly growing field dedicated to all aspects concerning the contact between chemical, biological, physical or psycho-social stressors and human and ecological receptors. With that, exposure science plays a central role in protecting human and ecosystem health, and contributes to the global transition towards a green and sustainable society. In Europe, however, exposure science is currently not sufficiently recognised as a scientific field, resulting in inefficient uptake into policies. In response, the wider European exposure science community developed elements and actions under the auspices of the Europe Regional Chapter of the International Society of Exposure Science (ISES Europe), for identified priority areas, namely education, exposure models, exposure data, human biomonitoring, and policy uptake. In the present document, we synthesize these strategic elements into an overarching ‘European Exposure Science Strategy 2020–2030’, following three strategic objectives that focus on acknowledging exposure science as an independent and interconnected field, harmonizing approaches and tools across regulations, and exploring collaboration, education and funding mechanisms. To operationalise this strategy, we present concrete key actions and propose initiatives and funding options for advancing the underlying science, cultivating broader education and cross-sector exposure knowledge transfer, and fostering effective uptake of exposure information into policy. We aim at anchoring European efforts in the global exposure science context, with a special focus on the interface between scientific advancements, application in decision support, and dissemination and training. This will help to develop exposure science as a strong scientific field with the ultimate goal to successfully assess and manage various stressors across sectors and geographic scales. ISSN:0160-4120 ISSN:1873-6750
Keywords	Human exposure ; Ecosystem exposure ; Exposure assessment ; Risk assessment ; Safe and sustainable-by-design (SSbD) ; International Society of Exposure Science
Subject code	333
Language	English
Publisher	Elsevier
Publishing country	ch
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Evaporation of decamethylcyclopentasiloxane (D5) from selected cosmetic products: Implications for consumer exposure modeling

Dudzina, Tatsiana / Christian Bogdal / Elena Garcia Hidalgo / Konrad Hungerbuehler / Natalie von Goetz

Environment international. 2015 Nov., v. 84

2015

Abstract: Consumer exposure to leave-on cosmetics and personal care products (C&PCPs) ingredients of low or moderate volatility is often assumed to occur primarily via dermal absorption. In reality they may volatilize from skin and represent a significant source ... ...

Abstract	Consumer exposure to leave-on cosmetics and personal care products (C&PCPs) ingredients of low or moderate volatility is often assumed to occur primarily via dermal absorption. In reality they may volatilize from skin and represent a significant source for inhalation exposure. Often, evaporation rates of pure substances from inert surfaces are used as a surrogate for evaporation from more complex product matrices. Also the influence of partitioning to skin is neglected and the resulting inaccuracies are not known. In this paper we describe a novel approach for measuring chemical evaporation rates from C&PCPs under realistic consumer exposure conditions. Series of experiments were carried out in a custom-made ventilated chamber fitted with a vapor trap to study the disposition of a volatile cosmetic ingredient, decamethylcyclopentasiloxane (D5), after its topical application on either aluminum foil or porcine skin in vitro. Single doses were applied neat and in commercial deodorant and face cream formulations at normal room (23Â°C) and skin temperature (32Â°C). The condition-specific evaporation rates were determined as the chemical mass loss per unit surface area at different time intervals over 1â1.25h post-dose. Product weight loss was monitored gravimetrically and the residual D5 concentrations were analyzed with GC/FID. The release of D5 from exposed surfaces of aluminum occurred very fast with mean rates of 0.029mgcmâ2minâ1 and 0.060mgcmâ2minâ1 at 23Â°C and 32Â°C, respectively. Statistical analysis of experimental data confirmed a significant effect of cosmetic formulations on the evaporation of D5 with the largest effect (2-fold decrease of the evaporation rate) observed for the neat face cream pair at 32Â°C. The developed approach explicitly considers the initial penetration and evaporation of a substance from the Stratum Corneum and has the potential for application in dermal exposure modeling, product emission tests and the formulation of C&PCPs.
Keywords	absorption ; aluminum ; aluminum foil ; deodorants ; dermal exposure ; evaporation rate ; exposure models ; ingredients ; inhalation exposure ; skin temperature ; statistical analysis ; surface area ; swine ; topical application ; vapors ; weight loss
Language	English
Dates of publication	2015-11
Size	p. 55-63.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	554791-x
ISSN	1873-6750 ; 0160-4120
ISSN (online)	1873-6750
ISSN	0160-4120
DOI	10.1016/j.envint.2015.07.013
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Exposure modelling in Europe: how to pave the road for the future as part of the European Exposure Science Strategy 2020-2030.

Journal of exposure science & environmental epidemiology

2022 Volume 32, Issue 4, Page(s) 499–512

Abstract: Exposure models are essential in almost all relevant contexts for exposure science. To address the numerous challenges and gaps that exist, exposure modelling is one of the priority areas of the European Exposure Science Strategy developed by the ... ...

Abstract	Exposure models are essential in almost all relevant contexts for exposure science. To address the numerous challenges and gaps that exist, exposure modelling is one of the priority areas of the European Exposure Science Strategy developed by the European Chapter of the International Society of Exposure Science (ISES Europe). A strategy was developed for the priority area of exposure modelling in Europe with four strategic objectives. These objectives are (1) improvement of models and tools, (2) development of new methodologies and support for understudied fields, (3) improvement of model use and (4) regulatory needs for modelling. In a bottom-up approach, exposure modellers from different European countries and institutions who are active in the fields of occupational, population and environmental exposure science pooled their expertise under the umbrella of the ISES Europe Working Group on exposure models. This working group assessed the state-of-the-art of exposure modelling in Europe by developing an inventory of exposure models used in Europe and reviewing the existing literature on pitfalls for exposure modelling, in order to identify crucial modelling-related strategy elements. Decisive actions were defined for ISES Europe stakeholders, including collecting available models and accompanying information in a living document curated and published by ISES Europe, as well as a long-term goal of developing a best-practices handbook. Alongside these actions, recommendations were developed and addressed to stakeholders outside of ISES Europe. Four strategic objectives were identified with an associated action plan and roadmap for the implementation of the European Exposure Science Strategy for exposure modelling. This strategic plan will foster a common understanding of modelling-related methodology, terminology and future research in Europe, and have a broader impact on strategic considerations globally.
MeSH term(s)	Environmental Exposure ; Europe ; Humans
Language	English
Publishing date	2022-08-02
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2218551-3
ISSN	1559-064X ; 1559-0631
ISSN (online)	1559-064X
ISSN	1559-0631
DOI	10.1038/s41370-022-00455-4
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Article ; Online: Evaporation of decamethylcyclopentasiloxane (D5) from selected cosmetic products: Implications for consumer exposure modeling.

Dudzina, Tatsiana / Garcia Hidalgo, Elena / von Goetz, Natalie / Bogdal, Christian / Hungerbuehler, Konrad

Environment international

2015 Volume 84, Page(s) 55–63

Abstract	Consumer exposure to leave-on cosmetics and personal care products (C&PCPs) ingredients of low or moderate volatility is often assumed to occur primarily via dermal absorption. In reality they may volatilize from skin and represent a significant source for inhalation exposure. Often, evaporation rates of pure substances from inert surfaces are used as a surrogate for evaporation from more complex product matrices. Also the influence of partitioning to skin is neglected and the resulting inaccuracies are not known. In this paper we describe a novel approach for measuring chemical evaporation rates from C&PCPs under realistic consumer exposure conditions. Series of experiments were carried out in a custom-made ventilated chamber fitted with a vapor trap to study the disposition of a volatile cosmetic ingredient, decamethylcyclopentasiloxane (D5), after its topical application on either aluminum foil or porcine skin in vitro. Single doses were applied neat and in commercial deodorant and face cream formulations at normal room (23°C) and skin temperature (32°C). The condition-specific evaporation rates were determined as the chemical mass loss per unit surface area at different time intervals over 1-1.25h post-dose. Product weight loss was monitored gravimetrically and the residual D5 concentrations were analyzed with GC/FID. The release of D5 from exposed surfaces of aluminum occurred very fast with mean rates of 0.029 mg cm(-2)min(-1) and 0.060 mg cm(-2)min(-1) at 23°C and 32°C, respectively. Statistical analysis of experimental data confirmed a significant effect of cosmetic formulations on the evaporation of D5 with the largest effect (2-fold decrease of the evaporation rate) observed for the neat face cream pair at 32°C. The developed approach explicitly considers the initial penetration and evaporation of a substance from the Stratum Corneum and has the potential for application in dermal exposure modeling, product emission tests and the formulation of C&PCPs.
MeSH term(s)	Administration, Cutaneous ; Animals ; Cosmetics/analysis ; Cosmetics/pharmacokinetics ; Humans ; In Vitro Techniques ; Inhalation Exposure/analysis ; Models, Biological ; Siloxanes/analysis ; Siloxanes/pharmacokinetics ; Skin ; Skin Absorption ; Swine ; Volatilization
Chemical Substances	Cosmetics ; Siloxanes ; decamethylcyclopentasiloxane (0THT5PCI0R)
Language	English
Publishing date	2015-11
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	554791-x
ISSN	1873-6750 ; 0160-4120
ISSN (online)	1873-6750
ISSN	0160-4120
DOI	10.1016/j.envint.2015.07.013
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Article ; Online: Concentrations of cyclic volatile methylsiloxanes in European cosmetics and personal care products: prerequisite for human and environmental exposure assessment.

Dudzina, Tatsiana / von Goetz, Natalie / Bogdal, Christian / Biesterbos, Jacqueline W H / Hungerbühler, Konrad

Environment international

2014 Volume 62, Page(s) 86–94

Abstract: Low molecular weight cyclic volatile methylsiloxanes (cVMSs) are widely employed as emollients and carrier solvents in personal care formulations in order to acquire desired performance benefits owing to their distinctive physicochemical properties. ... ...

Abstract	Low molecular weight cyclic volatile methylsiloxanes (cVMSs) are widely employed as emollients and carrier solvents in personal care formulations in order to acquire desired performance benefits owing to their distinctive physicochemical properties. Under current European legislation cosmetic ingredients such as cVMSs are required to be labeled on the product package only qualitatively, while for the assessment of environmental and consumer exposure quantitative information is needed. The aim of this study was therefore to measure concentrations of three cVMSs, namely octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) in 51 cosmetics and personal care products (C&PCPs) that are currently available on the European market. The list of selected articles comprised a variety of hair and sun care products, skin creams and lotions, deodorants including antiperspirants, liquid foundations and a toothpaste. The target compounds were extracted from the products with different organic solvents dependent on the product matrix, followed by gas chromatography analysis with flame ionization detection (GC-FID). D5 was the predominant cVMS with the highest mean and median concentrations in all the C&PCP categories. The median concentrations of D5, D6 and D4 were 142, 2.3 and 0.053 mg/g in deodorants/antiperspirants (n = 11); 44.6, 30.0mg/g and below the limit of quantification (<LOQ; LOQ for D4 = 0.00071 mg/g) in cosmetics (n = 5); 8.4, 0.32 mg/g and <LOQ in skin care (n = 16); 9.6, 0.18 and 0.0055 mg/g in hair care (n = 10); and, 34.8, 0.53 and 0.0085 mg/g in sun care (n = 8) products, respectively. The calculated median aggregate daily dermal exposure to D4 and D5 from multiple C&PCPs was approximately 100 times lower than the current NOAEL derived from chronic inhalation rat studies.<br />
MeSH term(s)	Administration, Cutaneous ; Cosmetics/chemistry ; Environmental Exposure ; Europe ; Humans ; Siloxanes/analysis ; Siloxanes/chemistry
Chemical Substances	Cosmetics ; Siloxanes
Language	English
Publishing date	2014-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	554791-x
ISSN	1873-6750 ; 0160-4120
ISSN (online)	1873-6750
ISSN	0160-4120
DOI	10.1016/j.envint.2013.10.002
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