Risk assessment of local dermal effects and skin sensitisation under the EU Chemicals Regulation REACH: A proposal for a qualitative, exposure scenario specific, approach

Risk assessment of local dermal effects and skin sensitisation under the EU Chemicals Regulation REACH: A proposal for a qualitative, exposure scenario specific, approach

Schaafsma, G.
Hertsenberg, A.J.
Marquart, J.

2011

Within the framework of REACH, an assessment regarding local dermal effects and skin sensitisation should be performed for substances. Quantitative hazard information for these effects is often not available. Furthermore, it is difficult to relate the way in which animals are exposed in dermal toxicity studies directly to dermal exposure in practice. In the absence of quantitative information, a qualitative assessment for dermal effects is the most reasonable option. The qualitative approach as proposed in the REACH guidance recommends only general risk management measures (RMM) for three categories with a low, moderate and high identified hazard, without specifying which RMM are needed for a specific exposure scenario. We propose to differentiate frequency of exposure based on differences in activities and to compare measured and estimated local skin exposure levels with rules of thumb for evaluation of control of risks per hazard category. For workers, specific RMM regimes are assigned to each combination of hazard category and process category (PROC). For consumers, a strategy in which RMM are arranged from product-integrated measures to the use of personal protective equipment (PPE) is presented. Our approach may be transferred into automated assessment tools like Chesar and CEFIC GES. © 2011 Elsevier Inc.

Triskelion BV
CRA - Chemical Risk Analysis
EELS - Earth, Environmental and Life Sciences
Dermal exposure
Exposure scenario
Local dermal effects
Qualitative risk assessment
REACH
Risk management measures (RMM)
Skin irritation
Skin sensitisation

http://resolver.tudelft.nl/uuid:a61b87f6-c94b-426b-a07c-34c083492a52

https://doi.org/10.1016/j.yrtph.2011.04.007

431368

0273-2300

Regulatory Toxicology and Pharmacology, 60 (3), 308-317

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