Applicability of surface sampling and calculation of surface limits for pharmaceutical drug substances for occupational health purposes.

Within the context of Occupational Hygiene (OH), surface sampling has been employed as a method to assess surface levels of Active Pharmaceutical Ingredients (APIs). There are potentially a number of reasons surface samples are collected including assessing potential health risks, housekeeping and cleaning effectiveness. There are no internationally accepted standards relating to collecting or interpreting surface samples for OH purposes. In the past, surface sampling results have been applied not only for estimating risks due to dermal contact, but also for other routes of exposure (e.g. inhalation, ingestion, etc). In this publication, we provide a decision tree to support the decision and value of performing surface sampling. For scenarios without conceivable skin exposure due to applied risk mitigation measures or for substances that do not penetrate the skin, surface sampling may not be needed. If the workers' health is determined to be at risk for systemic effects via skin, we propose to use the skin Permitted Daily Exposure (PDEskin), a safe skin dose independent of the exposure scenario that takes into consideration skin absorption properties of substances. For the purpose of OH monitoring, the likelihood of dermal exposure has to be understood before taking any samples, using both the PDEskin to calculate the surface limit and appropriate validated monitoring method for the surface.

Guidance on classification for reproductive toxicity under the globally harmonized system of classification and labelling of chemicals (GHS).

The Globally Harmonised System of Classification (GHS) is a framework within which the intrinsic hazards of substances may be determined and communicated. It is not a legislative instrument per se, but is enacted into national legislation with the appropriate legislative instruments. GHS covers many aspects of effects upon health and the environment, including adverse effects upon sexual function and fertility or on development. Classification for these effects is based upon observations in humans or from properly designed experiments in animals, although only the latter is covered herein. The decision to classify a substance based upon experimental data, and the category of classification ascribed, is determined by the level of evidence that is available for an adverse effect on sexual function and fertility or on development that does not arise as a secondary non-specific consequence of other toxic effect. This document offers guidance on the determination of level of concern as a measure of adversity, and the level of evidence to ascribe classification based on data from tests in laboratory animals.