Alternative Methodologies For The Safety Evaluation Of Chemicals In The Cosmetic Industry
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Alternative Methodologies For The Safety Evaluation Of Chemicals In The Cosmetic Industry
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Author : Nicola Loprieno
language : en
Publisher: CRC Press
Release Date : 2019-08-15
Alternative Methodologies For The Safety Evaluation Of Chemicals In The Cosmetic Industry written by Nicola Loprieno and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-15 with Medical categories.
First published in 1995: Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industry presents a categorization and collection of information available for the evaluation of safety using in vitro techniques. It offers a comprehensive and complete look at the entire field. In doing so, the author provides the foundation for the next phase of significant growth for this discipline.
The Sccs Notes Of Guidance For The Testing Of Cosmetic Ingredients And Their Safety Evaluation
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Author :
language : en
Publisher:
Release Date : 2022
The Sccs Notes Of Guidance For The Testing Of Cosmetic Ingredients And Their Safety Evaluation written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022 with categories.
In the present update, the state-of-the-art with respect to the validated methods of the 3Rs (Refinement, Reduction and Replacement) strategy of Russell et al. (1959), is incorporated with emphasis on New Approach Methodologies (NAMs). In view of the testing and marketing bans in the cosmetic regulation, the SCCS gives special attention to those alternative methods that are suitable for the safety testing of cosmetic substances. New methodologies for risk assessment of chemicals without using animal experimentation are worldwide being explored. Attention is given here to Next-Generation Risk Assessment (NGRA) as a possible framework for the safety evaluation of cosmetic ingredients and the NAMs that would fit into this structure (Rogiers et al., 2020). Risk assessment of cosmetics and their ingredients is shifting towards a strategic combination of NAMs and new technology with historical animal data, if available, to come to a Weight of Evidence (WoE) decision making approach. Although the "Notes of Guidance" are concerned with the testing and safety evaluation of the cosmetic substances listed in the Annexes of Regulation (EC) No 1223/2009 and those for which safety concerns have been expressed, they could be also of interest for all substances intended to be incorporated in a cosmetic product. Even though the "Notes of Guidance" have not been written for the latter purpose, they can indeed be of practical use in making a Product Information File (PIF) for a finished cosmetic product as currently required by Regulation (EC) No 1223/2009.
The Sccs Notes Of Guidance For The Testing Of Cosmetic Ingredients And Their Safety Evaluation
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Author :
language : en
Publisher:
Release Date : 2018
The Sccs Notes Of Guidance For The Testing Of Cosmetic Ingredients And Their Safety Evaluation written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.
Since July 2013, Regulation (EC) No 1223/2009 applies for cosmetic products. Their safety-in-use is, as was also the case for Directive 76/768/EEC, established by controlling the safety of the ingredients. For those ingredients for which some concern exists with respect to human health (e.g. colourants, preservatives, UV-filters, hair dyes), safety evaluation is done at the Commission level by the Scientific Committee on Consumer Safety (SCCS). These substances are addressed in the Annexes of Regulation (EC) No 1223/2009. For the safety evaluation of cosmetic ingredients, all available scientific data are considered, taking into account the testing and marketing bans in force under Regulation (EC) No 1223/2009. This includes the physical and chemical properties of the compounds under investigation, in silico data such as results obtained from (Q)SAR {(Quantitative) Structure Activity Relationship} modelling, chemical categories, grouping, read-across, Physiologically-Based PharmacoKinetics (PBPK) / ToxicoKinetics (PBTK) modelling, in vitro and ex vivo experimental results and data obtained from animal studies (in vivo) that have been carried out for the purpose of cosmetics before the testing and marketing bans. The animal testing ban on finished cosmetic products applies since 11 September 2004; the testing ban on ingredients or combination of ingredients applies since 11 March 2009. The marketing ban applies since 11 March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity, and toxicokinetics. For these specific health effects, the marketing ban applies since 11 March 2013, irrespective of the availability of alternative non-animal methods. In addition, clinical data, epidemiological studies, information derived from accidents, data from Post-Marketing Surveillance (PMS) or other human data are also taken into consideration. In the present update, the state-of-the-art with respect to the validated methods of the 3Rs (Refinement, Reduction and Replacement) strategy of Russell et al. (1959), is incorporated with emphasis on New Approach Methodologies (NAMs). In view of the testing and marketing bans in the cosmetic regulation, the SCCS gives special attention to those alternative methods that are suitable for the safety testing of cosmetic substances. Although the "Notes of Guidance" are concerned with the testing and safety evaluation of the cosmetic substances listed in the Annexes of Regulation (EC) No 1223/2009 and those for which safety concerns have been expressed, they could be also of interest for all substances intended to be incorporated in a cosmetic product. Even though the "Notes of Guidance" have not been written for the latter purpose, they can indeed be of practical use in making a Product Information File (PIF) for a finished cosmetic product as currently required by Regulation (EC) No 1223/2009. The "Notes of Guidance" should not be seen as a prescriptive procedure, but rather as an approach that may need to be adapted on a case-by-case basis when evaluating the safety of the Annex substances. However, when major deviations from standardised protocols/procedures in the safety evaluation process have been adopted, it is essential that Applicants provide scientific justification. The "Notes of Guidance" will be revised as scientifically required on the basis of scientific advances in toxicology and validated alternative methods or legislative changes.
Notes Of Guidance For The Testing Of Cosmetic Ingredients And Their Safety Evaluation
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Author :
language : en
Publisher:
Release Date : 2016
Notes Of Guidance For The Testing Of Cosmetic Ingredients And Their Safety Evaluation written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with categories.
The "Notes of Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS" is a document compiled by the members of the Scientific Committee on Consumer Safety (SCCS, replacing the former SCCP, SCCNFP and SCC). The document contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of this guidance is on cosmetic ingredients, although some guidance is also given for the safety assessment of finished products. It is designed to provide guidance to public authorities and to the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation. An important development was the 2009 legislative recast, which transformed the cosmetic Directive 76/768/EEC into a Regulation. It is emphasised that from 11 July 2013 onwards this Regulation (2009/1223/EC) was fully applicable. The European cosmetic legislation prohibits the marketing of finished products containing ingredients or combinations of ingredients that have been subject to animal testing after 2013. Therefore the SCCS has closely followed the progress made with regard to the development and validation of alternative methods.
Clinical Safety And Efficacy Testing Of Cosmetics
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Author : William Waggoner
language : en
Publisher: CRC Press
Release Date : 1989-11-27
Clinical Safety And Efficacy Testing Of Cosmetics written by William Waggoner and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989-11-27 with Medical categories.
American Book Publishing Record
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Author :
language : en
Publisher:
Release Date : 1995
American Book Publishing Record written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with American literature categories.
In Silico Toxicology
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Author : Mark T. D. Cronin
language : en
Publisher: Royal Society of Chemistry
Release Date : 2010
In Silico Toxicology written by Mark T. D. Cronin and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical categories.
This book defines the use of computational approaches to predict the environmental toxicity and human health effects of organic chemicals.
Animal Cell Culture Techniques
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Author : Martin Clynes
language : en
Publisher: Springer
Release Date : 1998-06-16
Animal Cell Culture Techniques written by Martin Clynes and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-06-16 with Medical categories.
Laboratory manual on cell culture techniques. Includes: cell proliferation and death; in vitro models for cell differentiation, toxicology, and pharmacology; industrial applications; genetic manipulation and analysis of human and animal cells in culture. Halftone and color illustrations.
Validation And Regulatory Acceptance Of Toxicological Test Methods
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Author :
language : en
Publisher:
Release Date : 1997
Validation And Regulatory Acceptance Of Toxicological Test Methods written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Toxicity testing categories.
Antisense Oligodeoxynucleotides And Antisense Rna
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Author : Benjamin Weiss
language : en
Publisher: CRC Press
Release Date : 1997-06-23
Antisense Oligodeoxynucleotides And Antisense Rna written by Benjamin Weiss and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-06-23 with Medical categories.
A practical, up-to-date treatise on this technology and its potential application in therapeutics. It features critical analyses of the specificity of the agents, and the possibility of antisense oligomers acting through non-antisense mechanisms. The history of early development of antisense oligodeoxynucleotides and their chemical modification to increase their stability is followed by delivery and penetration into cells, non-antisense effects of antisense oligonucleotides, pharmacokinetic properties; in vitro and in vivo model systems, and clinical trials.