Dose-response relationship of 1,3-butadiene: A systematic review with quality assessment of study results

Rapport - 2021

Resume

Scientific risk assessment of chemicalagents is based on the probability that an adverse health effect occurs at a defined exposure level. Hence, it is essential to quantify the risk to human health of occupational exposures. The occupational safety and health community aims to improve the methodology for risk assessment and derivation of dose-response relationships (DRRs). The joint research program of the PEROSH institutes (Partnership for European Research in Occupational Safety and Health) launched a project on DRRs and collaborated
on the derivation of dose-response relationships for relevant chemical substances in order to promote knowledge transfer on risk assessment methodologies. Our Working Group DRR has developed a recommendation for the methodology for the derivation of dose-response relationships for chemical substances as part of risk assessment. In a pilot study, 1,3-butadiene (CAS 106-99-0), a substance used mainly in the manufacture of synthetic rubber, was chosen for application of the proposed DRR methodology. A systematic review was performed: the systematic identification and evaluation of toxicological and epidemiological studies on 1,3-butadiene and the consideration of the quality of the studies for study selection and analysis were essential steps for this review. We aimed to derive the DRRs for six specific outcomes: local effects on skin and mucous membranes, allergenic effects, reproductive toxicity, genotoxicity, mutagenicity and carcinogenicity. For animal studies, we summarized the available LOELs (Lowest Observed Effect Levels) for each outcome as medians, if possible, according to the quality score of the studies. We extracted LOELs from the studies because only few studies would have enabled NOELs (No Observed Effect Levels) to be extracted. For human studies, we summarized the available
risk estimates of high-quality studies for selected lymphohematopoietic cancers to derive DRRs. Overall, the results of toxicological studies on 1,3-butadiene show effects for most of the outcomes, but the effect levels are characterized by a high degree of heterogeneity. The results of the epidemiological studies show a trend for a dose-response relationship of 1,3-butadiene for some cancers of the lymphohematopoietic system. The developed methodology for derivation of DRRs proved useful and can be recommended for the research and regulatory community in occupational safety and health.

Reference

Dose-response relationship of 1,3-butadiene: A systematic review with quality assessment of study results. Partnership for European Research in Occupational Safety and Health - PEROSH, 2021.
doi: 10.23775/20210523

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