Occupational exposure limits for reproductive toxicants – A comparative analysis

• Published in: Reproductive toxicology (Elmsford, N.Y.) Vol. 128; p. 108649
• Main Authors: Schenk, Linda, Ho, Meng-Rung, Taxell, Piia, Huuskonen, Pasi, Leite, Mimmi, Martinsone, Inese, Nordby, Karl-Christian, Paegle, Linda, Strumylaite, Loreta
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2024
• Subjects: Animals; DNEL; Hazardous Substances - toxicity; Health risk assessment; Humans; Industrial hygiene; Inhalation Exposure - adverse effects; Maximum allowable concentration; Medicin och hälsovetenskap; No-Observed-Adverse-Effect Level; Occupational Exposure; Reproduction - drug effects; Reproductive toxicology; Risk Assessment; Route-to-route extrapolation; TLV; Uncertainty factors; IOELV; Route-to-route extrapolation; CMRD; PoD; wDNEL; CLP; MAK Commission; wDMEL; DMEL; DNEL; SCOEL; Uncertainty factors; TWA; TLV; BOELV; Maximum allowable concentration; EU; REACH; CAS; RAC; ECHA; OEL; Industrial hygiene; Health risk assessment; Reproductive toxicology
• ISSN: 0890-6238; 1873-1708; 1873-1708
• DOI: 10.1016/j.reprotox.2024.108649

We investigated the level of protection of reproductive and developmental toxicity offered through occupational exposure limits (OELs) and Derived No-Effect Levels for workers’ inhalation exposure (wDNELs). We compared coverage of substances that have a harmonised classification as reproductive toxicant 1 A or 1B (Repr.1 A/B), numerical values and scientific basis of 12 lists of OELs and wDNELs from REACH Registrants’ and the Committee for Risk Assessment. Across the 14 sources of OELs and wDNELs, 53 % of the Repr1A/B-substances had at least one exposure limit (counting groups of metals as one entry). Registrants’ wDNELs covered the largest share, 40 %. The numerical values could be highly variable for the same substance across the lists. How often reproductive toxicity is identified as the critical effect varies between the examined lists, both due to different assessments of the same substance and different substance coverage. Reviewing the margin of safety to reproductive toxicity cited in the documents, we found that 15 % of safety margins were lower to reproductive toxicity than the critical effect. To conclude, neither the REACH nor work environment legislation supply wDNELs or OELs for a substantial share of known reproductive toxicants. EU OELs cover among the fewest substances in the range, and in many cases national OELs or wDNELs are set at more conservative levels. •14 sources of exposure limits were investigated.•53 % of Repr1A/B-substances have >1 exposure limit (counting groups of metals once).•Numerical values could be highly variable for the same substances.•Weight given to reproductive toxicity in scientific basis varied.