The Effects of Chemicals on Mammalian Fertility

Bremer, Susanne; Balduzzi, Donatella; Cortvrindt, R.; Daston, George P.; Eletti, Brighitta; Galli, Andrea; Huhtaniemi, Ilpo; Laws, Susan C.; Lazzari, Giovanna; Liminga, Ulla; Smitz, Johan; Spanò, Marcello; Themmen, Axel P. N.; Tilloy, Anne; Waalkens-Behrends, Ine

doi:10.1177/026119290503300406

Cited by 17 publications

(1 citation statement)

References 125 publications

(51 reference statements)

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“…The creation of an alternative testing strategy for reproductive toxicity was tasked to the Integrated Project ReProTect, a consortium set up by the ECVAM [109]. This project identified four research areas of interest: three coinciding with the different phases of the reproductive cycle, and a fourth dedicated to the identification of endocrine disrupters [110]. During its final year, this project conducted a ring trial where blinded chemicals with welldocumented toxicological profiles underwent a battery of 14 in vitro tests developed within ReProTect.…”

Section: Reproductive Toxicity/endocrine Disruptionmentioning

confidence: 99%

A State-of-the-Art Review on the Alternatives to Animal Testing for the Safety Assessment of Cosmetics

Silva

Tamburić

2022

Cosmetics

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Almost a decade after the stipulated deadline in the 7th amendment to the EU Cosmetics Directive, which bans the marketing of animal-tested cosmetics in the EU from 2013, animal experimentation for cosmetic-related purposes remains a topic of animated debate. Cosmetic industry continues to be scrutinised for the practice, despite its leading role in funding and adopting innovation in this field. This paper aims to provide a state-of-the-art review of the field on alternative testing methods, also known as New Approach Methodologies (NAMs), with the focus on assessing the safety of cosmetic ingredients and products. It starts with innovation drivers and global regulatory responses, followed by an extensive, endpoint-specific overview of accepted/prospective NAMs. The overview covers main developments in acute toxicity, skin corrosion/irritation, serious eye damage/irritation, skin sensitisation, repeated dose toxicity, reproductive toxicity/endocrine disruption, mutagenicity/genotoxicity, carcinogenicity, photo-induced toxicity, and toxicokinetics. Specific attention was paid to the emerging in silico methodology. This paper also provides a brief overview of the studies on public perception of animal testing in cosmetics. It concludes with a view that educating consumers and inviting them to take part in advocacy could be an effective tool to achieve policy changes, regulatory acceptance, and investment in innovation.

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Section: Reproductive Toxicity/endocrine Disruptionmentioning

confidence: 99%

A State-of-the-Art Review on the Alternatives to Animal Testing for the Safety Assessment of Cosmetics

Silva

Tamburić

2022

Cosmetics

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ECVAM and New Technologies for Toxicity Testing

d’Yvoire

Bremer

Casati

et al. 2012

Advances in Experimental Medicine and Biology

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Alternative methods to safety studies in experimental animals: role in the risk assessment of chemicals under the new European Chemicals Legislation (REACH)

Lilienblum¹,

Dekant

Foth³

et al. 2008

Arch Toxicol

253

122

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During the last two decades, substantial efforts have been made towards the development and international acceptance of alternative methods to safety studies using laboratory animals. In the EU, challenging timelines for phasing out of many standard tests using laboratory animals were established in the seventh Amending Directive 2003/15/EC to Cosmetics Directive 76/768/EEC. In continuation of this policy, the new European Chemicals Legislation (REACH) favours alternative methods to conventional in vivo testing, if validated and appropriate. Even alternative methods in the status of prevalidation or validation, but without scientific or regulatory acceptance may be used under certain conditions. Considerable progress in the establishment of alternative methods has been made in some fields, in particular with respect to methods predicting local toxic effects and genotoxicity. In more complex important fields of safety and risk assessment such as systemic single and repeated dose toxicity, toxicokinetics, sensitisation, reproductive toxicity and carcinogenicity, it is expected that the development and validation of in silico methods, testing batteries (in vitro and in silico) and tiered testing systems will have to overcome many scientific and regulatory obstacles which makes it extremely difficult to predict the outcome and the time needed. The main reasons are the complexity and limited knowledge of the biological processes involved on one hand and the long time frame until validation and regulatory acceptance of an alternative method on the other. New approaches in safety testing and evaluation using "Integrated Testing Strategies" (ITS) (including combinations of existing data, the use of chemical categories/grouping, in vitro tests and QSAR) that have not been validated or not gained wide acceptance in the scientific community and by regulatory authorities will need a thorough justification of their appropriateness for a given purpose. This requires the availability of knowledge and experience of experts in toxicology. The challenging deadlines for phasing out of in vivo tests in the Cosmetics Amending Directive 2003/15/EC appear unrealistic. Likewise, we expect that the application of validated alternative methods will only have a small or moderate impact on the reduction of in vivo tests under the regimen of REACH, provided that at least the same level of protection of human health as in the past is envisaged. As a consequence, under safety aspects, it appears wise to consider established in vivo tests to be indispensable as basic tools for hazard and risk assessment with respect to systemic single and repeated dose toxicity, sensitisation, carcinogenicity and reproductive toxicity, especially regarding quantitative aspects of risk assessment such as NOAELs, LOAELs and health-related limit values derived from them. Based on the overall evaluation in this review, the authors are of the opinion that in the short- and mid-term, the strategy of the development of alternative methods should be more directed towar...

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The Effects of Chemicals on Mammalian Fertility

Cited by 17 publications

References 125 publications

A State-of-the-Art Review on the Alternatives to Animal Testing for the Safety Assessment of Cosmetics

A State-of-the-Art Review on the Alternatives to Animal Testing for the Safety Assessment of Cosmetics

ECVAM and New Technologies for Toxicity Testing

Alternative methods to safety studies in experimental animals: role in the risk assessment of chemicals under the new European Chemicals Legislation (REACH)

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