When should a substance be designated as sensitizing for the skin (`Sh’) or for the airways (`Sa’)?

Abstract

<jats:p> In the List of MAK and BAT Values compounds are designated with `Sa’ (`sensitizing for the airways’) or `Sh’ (`sensitizing for the skin’) if, according to scientific evidence, they are allergens. Mainly based on suggestions by a WHO working group and based on our own experience, extended criteria have been elaborated by the working group `skin and allergy’ of the Commission of the Deutsche Forschungsgemeinschaft for the Investigation of Health Hazards of Chemical Compounds in the Work Area, which are presented in this article. They serve as guidelines for deciding which substances have to be labelled `Sa’ and `Sh’, respectively, for the prevention of sensitization and subsequent allergic diseases in workers. Although in some special cases their strict application may not be deemed necessary or possible, the proposed new criteria should be used to make the procedure of classification of substances: 1) more rational, 2) more consistent, 3) more comprehensible, and 4) more transparent. This paper informs readers working scientifically or administratively in this field and invites a critical discussion of the issue. </jats:p>

Primary prevention of occupational asthma: identifying and controlling exposures to asthma‐causing agents

“…Formaldehyde, the only substance regulated with a comprehensive standard to prevent asthma in the US, is not designated as an occupational asthmagen by NIOSH, the UK, and Germany. In addition to establishing identification criteria, periodic evaluation of the criteria to determine if they are effective in meeting occupational asthma prevention goals, and making necessary adjustments [Schnuch et al, 2002] is also critical.…”

“…Table IV shows the substances designated by the MAK Commission as respiratory allergens. The MAK designations are based upon established criteria ( Table I) that are an extended version of the European Union identification criteria [Schnuch et al, 2002]. Similar to the US, and in contrast to the UK, the majority of the identified respiratory allergens are industrial chemicals.…”

Chemical and biological work-related risks across occupations in Europe: a review

“…The identification of sensitising substances was based on the list of compounds published in 2013 by the German Commission for the Investigation of Health Hazards of Chemical Compounds (MAK-Commission) [15,16]. Sensitising substances, i.e.…”

Classification of dermal sensitizers in pharmaceutical manufacturing

“…A comparison between classifications of skin sensitizing substances by the German DFG-MAK commission (Deutsche Forschungsgemeinschaft, Maximale Arbeitsplatz Konzentrationen; Commission for the investigation of health hazards of chemical compounds in the work area) and by the EU legislation has been published by Lessmann et al (2011). Although the DFG-MAK commission uses its own criteria regarding the validity of available human and animal studies, weight of scientific evidence and presumed occupational exposure, there are few differences between the two classification schemes (Schnuch et al, 2002;Lessmann et al, 2011).…”

“…= not available. Gould and Taylor (2011) occupational exposure is taken into account (Schnuch et al, 2002). This is in line with the European Chemicals Agency (ECHA) guidance on information requirements and chemical safety assessment Part E: Risk characterization, which states that ''Since sensitisation is essentially systemic in nature, it is important for the purposes of risk management to acknowledge that skin sensitisation may be acquired by other routes of exposure than dermal.…”