The laboratory toxicologist is frequently faced with the challenge of selecting appropriate vehicles or developing utilitarian formulations for use in in vivo nonclinical safety assessment studies. Although there are many vehicles available that may meet physical and chemical requirements for chemical or pharmaceutical formulation, there are wide differences in species and route of administration specific to tolerances to these vehicles. In current practice, these differences are largely approached on a basis of individual experience as there is only scattered literature on individual vehicles and no comprehensive treatment or information source. This approach leads to excessive animal use and unplanned delays in testing and development. To address this need, a consulting firm and three contract research organizations conducted a rigorous data mining operation of control (vehicle) data from studies dating from 1991 to present. The results identified 65 single component vehicles used in 368 studies across multiple species (dog, primate, rat, mouse, rabbit, guinea pig, minipig, chick embryo, and cat) by multiple routes. Reported here are the results of this effort, including maximum tolerated use levels by species, route, and duration of study, with accompanying dose limiting toxicity. Also included are basic chemical information and a review of available literature on each vehicle, as well as guidance on volume limits and pH by route and some basic guidance on nonclinical formulation development.

/pdf/nonclinical-vehicle-use-in-studies-by-multiple-routes-in-3tagfs1xth.pdf

Nonclinical vehicle use in studies by multiple routes in multiple species.

In this review many examples are given of the complexities involved in using some biomarkers in relation to assessing the effects of dietary exposure, when there is frequently a need to determine changes following long-term low level exposure to dietary components. These range from understanding why the biomarker might be valuable and how best it can be measured, to the pitfalls which can occur in the interpretation of data. Analytical technique is considered in relation to folate and selenium, and flavonoid and carotenoid species are used to illustrate how the metabolism of a compound may alter the validity or adequacy of a marker. Vitamin A is discussed in relation to the difficulties which can arise when there are several biomarkers that may be available to assess exposure to one nutrient. Vitamin B12 is discussed in relation to the dietary choices made by individuals. Possible interactions and the role of measuring total antioxidant capacity is considered in some detail. In contrast to most nutrients, there is a marked lack of biomarkers of either exposure or effect for most non-nutrients. The role of biological effect monitoring is considered for dietary contaminants, fumonisins and polyhalogenated aromatic hydrocarbons. Aflatoxins are discussed to exemplify food contaminants for which the biomarker approach has been extensively studied. Finally some compounds which are deliberately added to foods and some which appear as processing contaminants are each considered briefly in relation to the requirement for a biomarker of exposure to be developed.

/pdf/a-critical-assessment-of-some-biomarker-approaches-linked-38e9oixepl.pdf

A critical assessment of some biomarker approaches linked with dietary intake.

Synopsis
This review was initially prepared in 2011 before Professor Johann Wiechers tragically passed away. It has been updated and is being published in his memory. It discusses the importance of mineral oil and its benefits to skin. Its source, structure, properties and efficacy are discussed. Mineral oil has been shown to improve skin softness and barrier function better than some other emollients using the gas-bearing dynamometer and standard water vapour transmission testing as well as in vivo studies showing its effects on suppressing transepidermal water loss (TEWL). It has also been subjected to the rigour of the newer in vivo confocal microscopic measurements now used for testing the performance of moisturizers by following the swelling characteristics of the stratum corneum and been found favourable compared with many vegetable oils. Its introduction as a cosmetic oil was in the late 1800s, and still today, it is used as one of the main components of moisturizers, a true testament to its cost to efficacy window. Naturally, it has physical effects on the stratum corneum, but it is expected that these will translate into biological effects simply through its mechanism of hydrating and occluding the stratum corneum from which many benefits are derived.

/pdf/a-review-on-the-extensive-skin-benefits-of-mineral-oil-41hinashy1.pdf

A review on the extensive skin benefits of mineral oil.

Review of data on the dermal penetration of mineral oils and waxes used in cosmetic applications.

http://www.dr-baumann-international.co.uk/science/Autoimmune%20Response%20Induced%20by%20Mineral%20Oil%202004.pdf

Distinctive patterns of autoimmune response induced by different types of mineral oil.

A toxicological review of topical exposure to white mineral oils.

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A toxicological review of topical exposure to white mineral oils.