Strategic hierarchical approaches to acute toxicity testing

Basketter, David A.

doi:10.1016/0887-2333(94)90086-8

Cited by 9 publications

(7 citation statements)

References 24 publications

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“…To replace the Draize rabbit skin irritation test, it is necessary to have an alternative that provides at least a similar type and quality of data. In this case, there is the special opportunity to use human volunteers, since it is both possible and practical to test skin irritation potential in an ethical manner in man (12)(13)(14)(15)(16)(17)(18). However, for global acceptance of data produced in a prospective human study and to provide reassurance of its broad relevance across ethnic, climatic and other divides, a number of studies have been put into place (reviewed in 16).…”

Section: Discussionmentioning

confidence: 99%

“…However, there is an increasing reluctance to use animals for this type of toxicology testing (6)(7)(8) and the rabbit model has been criticised for its poor predictive quality (9)(10)(11). Consequently, to avoid these problems, an alternative strategy has been proposed (12,13). This strategy involves the use of human volunteers for the identification of skin irritation hazard potential in a protocol that has been described previously (14,15).…”

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confidence: 99%

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The impact of atopic status on a predictive human test of skin irritation potential

1996

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There has been much interest in recent years in the replacement of the Draize rabbit skin test for the identification of chemical skin irritants. A considerable effort has gone into the development of cell culture based assays. However, where ethical and safety considerations permit, the most obvious alternative is to use man himself. Data obtained using a suitable assay based on the endpoint of concern in the species of concern should be accurate and will represent a vital data base on which to develop sound in vitro assays. Thus, it is important to ensure the data produced in human assays is representative for man generally. To this end we have chosen to examine a number of variables and in this work report the effect of atopic status on the results obtained in a recently described human 4-h patch test. 30 atopic (defined by specific IgE to common allergens and by elevated total IgE) and 28 non-atopic volunteers were tested in this human 4-h patch test using 20% sodium dodecyl sulfate (SDS), 10% hydrochloric acid (HCl) and undiluted cocotrimethyl ammonium chloride (coco TAC). The level of irritant reaction was higher for SDS in the atopic panel, but was similar for HCl and coco TAC. The rank order of irritancy was the same in both panels. The results indicate that, whilst the intensity of reactions may be higher in atopics, their pattern of responses is similar to non-atopics. There is no evidence to indicate that they should either be deliberately included or excluded from the test panels recruited on a routine basis.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

The impact of atopic status on a predictive human test of skin irritation potential

1996

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“…The idea of applying multiple testing strategies for hazard and safety assessment started more than twenty years ago (Basketter, 1994). The reasons why a single in vitro test may hardly replace a full in vivo test are explained by Natsch (2014), and may be summarized as follows: 1.…”

Section: Introductionmentioning

confidence: 99%

Integrated testing strategies (ITS) for safety assessment

Rovida

2015

ALTEX

147

128

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SummaryIntegrated testing strategies (ITS), as opposed to a single definitive test or fixed batteries of tests, are expected to efficiently combine different information sources in a quantifiable fashion to satisfy an information need, in this case for regulatory safety assessments. With increasing awareness of the limitations of each individual tool and the development of highly targeted tests and predictions, the need for combining pieces of evidence increases. The discussions that took place during this workshop, which brought together a group of experts coming from different related areas, illustrate the current state of the art of ITS, as well as promising developments and identifiable challenges. The case of skin sensitization was taken as an example to understand how possible ITS can be constructed, optimized and validated. This will require embracing and developing new concepts such as adverse outcome pathways (AOP), advanced statistical learning algorithms and machine learning, mechanistic validation and "Good ITS Practices".Keywords: in vitro methods, testing strategy, Tox21c, skin sensitization, computational toxicology this is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International license (http://creativecommons.org/ licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is appropriately cited. *A report of t 4 -the transatlantic think tank for toxicology, a collaboration of the toxicologically oriented chairs in Baltimore, Konstanz and Utrecht sponsored by the Doerenkamp-Zbinden Foundation; participants do not represent their institutions and do not necessarily endorse all recommendations made.

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“…6,11 Currently EC rules for the classification of substances and preparations rely primarily on the Draize rabbit skin test, the predictive value of which has been criticised on a number of counts.…”

Section: Discussionmentioning

confidence: 99%

Skin irritation testing in man for hazard assessment — evaluation of four patch systems

et al. 1995

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1 The limitations of the Draize rabbit skin irritation test for hazard evaluation for man are widely documented. Nevertheless it remains the prescribed method for deter mining acute skin irritation hazard. 2 While the use of human testing for risk assessment of irritants is well established, the use of predictive testing in man for hazard identification has not been explored widely, and this is the object of the research programme. 3 The experiment described in this report evaluates the sensitivity of four patch testing systems (Finn chamber, Hill Top patch, Van der Bend chamber, and Webril patch) using a total of six irritant substances. 4 Following preliminary range-finding experiments, test materials were applied to the upper outer arm for up to 4 h. Assessments were performed immediately after patch removal and at 1, 24, 48 and 72 h. 5 Webril and Hill Top patches generated the greatest lev els of response, although responses with Finn and Van der Bend were observed. Hill Top patches are recom mended for future development work. 6 The use of very small preliminary panels to predict the effects in larger panels using different volunteers was only of limited value as each volunteer was found to have different irritant thresholds.

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Strategic hierarchical approaches to acute toxicity testing

Cited by 9 publications

References 24 publications

The impact of atopic status on a predictive human test of skin irritation potential

The impact of atopic status on a predictive human test of skin irritation potential

Integrated testing strategies (ITS) for safety assessment

Skin irritation testing in man for hazard assessment — evaluation of four patch systems

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