Abstract
This study aims to evaluate the risk assessment approach of the REACH legislation in industrial chemical departments with a focus on the use of three models to calculate exposures, and discuss those factors that can determine a bias between the estimated exposure (and therefore the expected risk) in the extended safety data sheets (e-SDS) and the expected exposure for the actual scenario. To purse this goal, the exposure estimates and risk characterization ratios (RCRs) of registered exposure scenarios (ES; “communicated exposure” and “communicated RCR”) were compared with the exposure estimates and the corresponding RCRs calculated for the actual, observed ES, using recommended tools for the evaluation of exposure assessment and in particular the following tools: (i) the European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment v.3.1 (ECETOC TRA), (ii) STOFFENMANAGER® v.8.0 and (iii) the Advanced REACH Tool (ART). We evaluated 49 scenarios in three companies handling chemicals. Risk characterization ratios (RCRs) were calculated by dividing estimated exposures by derived no-effect levels (DNELs). Although the calculated exposure and RCRs generally were lower than communicated, the correlation between communicated and calculated exposures and RCRs was generally poor, indicating that the generic registered scenarios do not reflect actual working, exposure and risk conditions. Further, some observed scenarios resulted in calculated exposure values and RCR higher than those communicated through chemicals’ e-SDSs; thus ‘false safe’ scenarios (calculated RCRs > 1) were also observed. Overall, the obtained evidences contribute to doubt about whether the risk assessment should be performed using generic (communicated by suppliers) ES with insufficient detail of the specific scenario at all companies. Contrariwise, evidences suggested that it would be safer for downstream users to perform scenario-specific evaluations, by means of proper scaling approach, to achieve more representative estimates of chemical risk.
Highlights
The exposure estimates and risk characterization ratios (RCRs) of registered exposure scenarios (ES) (“communicated exposure” and “communicated RCR”) were compared with the exposure estimates and the corresponding RCRs calculated for the actual, observed ESs, using recommended tools by European Chemical Agency (ECHA) for the evaluation of exposure assessment [1] and in particular the following tools: (i) the European Centre for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment v.3.1 (ECETOC TRA, Brussels, Belgium), (ii) STOFFENMANAGER® v.8.0 and (iii) the Advanced REACH Tool v.1.5 (ART, Zeist, the Netherlands; www.advancedreachtool.com)
Exposure estimates and corresponding RCRs communicated through extended safety data sheets (e-SDS) were compared with scenarios studied at actual workplaces
Basic information were preferably collected from the e-SDS for the exposure modeling: information about physico-chemical properties, was often missing. These missing data was collected by searching in databases: using faulty data for occupational exposure modeling could have a great impact on exposure calculations and can lead to unreliable estimates
Summary
The provisions that downstream users must follow to obtain a controlled risk are communicated through the extended safety data sheets (e-SDSs) of chemicals [3]. The e-SDSs consists of SDSs (safety data sheets), a technical information documents on substances and mixtures, and their exposure scenarios (ES) which describe the permitted uses, operating conditions (OCs) and risk management measures (RMMs) to be respected for each activity performed within and highlighted by process categories (PROCs). For each of the identified uses in the lifecycle of a substance, the operational conditions and risk management measures ensuring control of risk must be determined. This set of information is called an exposure scenario (ES). If there are any differences in the OCs and RMMs, the user is required to verify whether in these different conditions (i.e., in the actual scenario) the use of the substance is safe
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