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Showing 1 to 12 of 122 entries
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Innovative Strategies to Develop Chemical Categories Using a Combination of Structural and Toxicological Properties.

Frontiers in pharmacology

Batke M, Gütlein M, Partosch F, Gundert-Remy U, Helma C, Kramer S, Maunz A, Seeland M, Bitsch A.
PMID: 27708580
Front Pharmacol. 2016 Sep 21;7:321. doi: 10.3389/fphar.2016.00321. eCollection 2016.

Interest is increasing in the development of non-animal methods for toxicological evaluations. These methods are however, particularly challenging for complex toxicological endpoints such as repeated dose toxicity. European Legislation, e.g., the European Union's Cosmetic Directive and REACH, demands the...

Physiologically based toxicokinetic modelling as a tool to support risk assessment: three case studies.

Journal of toxicology

Mielke H, Gundert-Remy U.
PMID: 22649449
J Toxicol. 2012;2012:359471. doi: 10.1155/2012/359471. Epub 2012 May 09.

In this contribution we present three case studies of physiologically based toxicokinetic (PBTK) modelling in regulatory risk assessment. (1) Age-dependent lower enzyme expression in the newborn leads to bisphenol A (BPA) blood levels which are near the levels of...

The Use of (Q)SAR Methods in the Context of REACH.

Toxicology mechanisms and methods

Lahl U, Gundert-Remy U.
PMID: 20020911
Toxicol Mech Methods. 2008;18(2):149-58. doi: 10.1080/15376510701857288.

ABSTRACT The new European REACH (Registration, Evaluation, Authorisation of Chemicals) legislation requires new information on chemicals, which is tiered according to production volume. The need for data promotes the use of (quantitative) structure-activity relationships ([Q]SARs) in order to meet...

Exposure of Infants to Isoniazid via Breast Milk After Maternal Drug Intake of Recommended Doses Is Clinically Insignificant Irrespective of Metaboliser Status. A Physiologically-Based Pharmacokinetic (PBPK) Modelling Approach to Estimate Drug Exposure of Infants via Breast-Feeding.

Frontiers in pharmacology

Garessus EDG, Mielke H, Gundert-Remy U.
PMID: 30723406
Front Pharmacol. 2019 Jan 22;10:5. doi: 10.3389/fphar.2019.00005. eCollection 2019.

Isoniazid is a first-line anti-tuberculosis drug recommended for treatment of drug-susceptible

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use.

EFSA journal. European Food Safety Authority

, Younes M, Aquilina G, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gürtler R, Gundert-Remy U, Husøy T, Mennes W, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Gott D, Leblanc JC, Smeraldi C, Tard A, Castle L.
PMID: 32626247
EFSA J. 2019 Mar 08;17(3):e05621. doi: 10.2903/j.efsa.2019.5621. eCollection 2019 Mar.

The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes...

Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19.

EFSA journal. European Food Safety Authority

, Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Vianello G, Mennes W.
PMID: 32626370
EFSA J. 2019 Jul 17;17(7):e05750. doi: 10.2903/j.efsa.2019.5750. eCollection 2019 Jul.

The Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority was requested to evaluate the genotoxic potential of the flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204 (FGE.204). In...

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19.

EFSA journal. European Food Safety Authority

, Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Husøy T, Mennes W, Moldeus P, Oskarsson A, Rainieri S, Shah R, Waalkens-Berendsen I, Wölfle D, Binderup ML, Bolognesi C, Marcon F, Marzin D, Mosesso P, Carfì M, Vianello G, Gürtler R.
PMID: 32625707
EFSA J. 2018 Oct 19;16(10):e05422. doi: 10.2903/j.efsa.2018.5422. eCollection 2018 Oct.

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1)....

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2-alkylated, aliphatic, acyclic alpha,beta-unsaturated aldehydes and precursors, with or without additional double-bonds, from chemical subgroup 1.1.2 of FGE.19.

EFSA journal. European Food Safety Authority

, Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Husøy T, Mennes W, Moldeus P, Oskarsson A, Rainieri S, Shah R, Waalkens-Berendsen I, Wölfle D, Binderup ML, Bolognesi C, Marcon F, Marzin D, Mosesso P, Anastassiadou M, Carfì M, Vianello G, Gürtler R.
PMID: 32625708
EFSA J. 2018 Oct 17;16(10):e05423. doi: 10.2903/j.efsa.2018.5423. eCollection 2018 Oct.

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2-methylpent-2-enal...

Re-evaluation of gellan gum (E 418) as food additive.

EFSA journal. European Food Safety Authority

, Younes M, Aggett P, Aguilar F, Crebelli R, Filipic M, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Kuhnle GG, Lambré C, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Wright M, Brimer L, Mosesso P, Christodoulidou A, Cascio C, Tard A, Lodi F, Dusemund B.
PMID: 32625935
EFSA J. 2018 Jun 20;16(6):e05296. doi: 10.2903/j.efsa.2018.5296. eCollection 2018 Jun.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of gellan gum (E 418) as a food additive. Following the conceptual framework for the risk assessment of certain food...

Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171).

EFSA journal. European Food Safety Authority

, Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, Filipič M, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Kuhnle GG, Lambré C, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Wright M, Lodi F, Rincon AM, Smeraldi C, Woutersen RA.
PMID: 32625996
EFSA J. 2018 Jul 04;16(7):e05366. doi: 10.2903/j.efsa.2018.5366. eCollection 2018 Jul.

The European Commission requested EFSA to carry out a scientific evaluation on four studies on the potential toxicity of titanium dioxide (TiO

Re-evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) as food additives.

EFSA journal. European Food Safety Authority

, Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, Filipič M, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Kuhnle GG, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Wright M, Boon P, Gürtler R, Mosesso P, Parent-Massin D, Tobback P, Chrysafidis D, Rincon AM, Tard A, Lambré C.
PMID: 32626019
EFSA J. 2018 Aug 02;16(8):e05375. doi: 10.2903/j.efsa.2018.5375. eCollection 2018 Aug.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) when used as food additives. In...

Scientific Opinion on Flavouring Group Evaluation 71 Revision 1 (FGE.71Rev1): consideration of aliphatic, linear, α,β-unsaturated alcohols, aldehydes, carboxylic acids, and related esters evaluated by JECFA (63rd and 69th meeting) structurally related to flavouring substances evaluated in FGE.05Rev3.

EFSA journal. European Food Safety Authority

, Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Martino C, Mennes W.
PMID: 32626481
EFSA J. 2020 Jan 09;18(1):e05924. doi: 10.2903/j.efsa.2020.5924. eCollection 2020 Jan.

The EFSA Panel on Food Additives and Flavourings was requested to evaluate 39 flavouring substances assigned to the Flavouring Group Evaluation 71 (FGE.71), using the Procedure in Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in...

Showing 1 to 12 of 122 entries