Comparative testing for the identification of skin-sensitizing potentials of nonionic sugar lipid surfactants

Garcia, Christine; Ball, Nicholas; Cagen, Stuart Z.; Carrillo, Juan-Carlos; Certa, Hans; Eigler, Dorothea; Esch, Harald L.; Graham, Cynthia; Haux, Carl; Kreiling, Reinhard; Mehling, Annette

doi:10.1016/j.yrtph.2010.06.016

Cited by 25 publications

(15 citation statements)

References 17 publications

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“…This has led to the development of a range of practical experiences, from both industry and regulatory bodies. As the LLNA is now the prescribed method under REACH, for the first of these groups, a dominant issue has been the reliable identification of a sensitization hazard without the generation of an excessive number of false positive results (Basketter et al, 1998(Basketter et al, , 2009aVohr and Ahr, 2005;Kreiling et al, 2008;Garcia et al, 2010;Ball et al, 2011). For the latter, there has been a more general sharing of the experience with the variety of challenges presented by regulatory submissions (Cockshott et al, 2006;McGarry, 2007;Angers-Loustau et al, 2011).…”

Section: Experience Of Use Of the Llna In Practisementioning

confidence: 99%

Optimised testing strategies for skin sensitization – The LLNA and beyond

Basketter

Crozier²,

Hubesch

et al. 2012

Regulatory Toxicology and Pharmacology

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Section: Experience Of Use Of the Llna In Practisementioning

confidence: 99%

Optimised testing strategies for skin sensitization – The LLNA and beyond

Basketter

Crozier²,

Hubesch

et al. 2012

Regulatory Toxicology and Pharmacology

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“…Consequently, it remains necessary to address limitations of the in vivo method, not least as understanding them may well help to ensure that the eventual replacement will offer scientific as well as ethical benefits. Issues identified with the LLNA have included the question of false–positive responses with certain classes of substance (Ball et al ., ; Garcia et al ., ; Kreiling et al ., ), which has driven strongly the argument that skin sensitization classification should be determined on a weight of evidence basis (Ball et al ., ; Basketter et al ., ). However, in the present study a different issue has been addressed – the use of radioactivity in the standard LLNA and whether deployment of an alternative endpoint, lymph node cell counts, can offer not only a similar quality of hazard identification, but also deliver an estimation of the relative potency of an identified skin sensitizer.…”

Section: Discussionmentioning

confidence: 99%

Further experience with the local lymph node assay using standard radioactive and nonradioactive cell count measurements

Kolle

Basketter

Schrage

et al. 2012

J of Applied Toxicology

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In a previous study, the predictive capacity of a modified local lymph node assay (LLNA) based on cell counts, the LNCC, was demonstrated to be closely similar to that of the original assay. In addition, a range of substances, including some technical/commercial materials and a range of agrochemical formulations (n = 180) have also been assessed in both methods in parallel. The results in the LNCC and LLNA were generally consistent, with 86% yielding an identical classification outcome. Discordant results were associated with borderline data and were evenly distributed between the two methods. Potency information derived from each method also demonstrated good consistency (n = 101), with 93% of predictions being close. Skin irritation was observed only infrequently and was most commonly associated with positive results; it was not associated with the discordant results. Where different vehicles were used with the same test material, the effect on sensitizing activity was modest, consistent with historical data. Analysis of positive control data indicated that the LNCC and LLNA displayed similar levels of biological variation. When taken in combination with the previously published results on LLNA Performance Standard chemicals, it is concluded that the LNCC provides a viable non-radioactive alternative to the LLNA for the assessment of substances, including potency predictions, as well as for the evaluation of preparations.

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“…Octyldodecyl xyloside is present in a number of currently available cosmetic products (1). Structurally, it belongs to the glycoside group, a family of small organic molecules in which a sugar component (glycone) is bound to a non‐carbohydrate component (aglycone) by a glycosidic bond.…”

Section: Discussionmentioning

confidence: 99%

“…A recent animal study using the local lymph node assay (LLNA), a method of assessing the skin‐sensitizing capabilities of a chemical, reported that octyldodecyl xyloside (referred to as C18 branched glucoside) invoked a response. However, the response was not dose‐related, and it was felt that this might reflect an irritant reaction similar to that seen with other surfactants in the LLNA (1). Another report concluded that there was no evidence of reactions indicative of skin sensitization to octyldodecyl xyloside in animal studies (4).…”

Section: Discussionmentioning

confidence: 99%