Title
Use of read-across and tiered exposure assessment in risk assessment under REACH - A case study on a phase-in substance
Author
Vink, S.R.
Mikkers, J.
Bouwman, T.
Marquart, H.
Kroese, E.D.
TNO Kwaliteit van Leven
Publication year
2010
Abstract
REACH requests the exploration of alternative strategies for hazard identification before resorting to (in vivo) testing. Here, we combined read-across as non-testing strategy with a tiered exposure assessment for the risk characterisation of 1-methoxypropan-2-ol (PGME) as a representative for phase-in substances to be registered under REACH. Read-across from the selected source substances provided data which were comparable with experimental data available for target substance PGME, resulting in a realistic starting point for both qualitative and quantitative risk assessment. Greater variability was observed in the exposure estimates from a first Tier model (ECETOC TRA) or less conservative further Tier models (Stoffenmanager; RISKOFDERM), when these results were compared with results from a data-rich approach using measured data.When safe use of chemicals cannot be demonstrated with these approaches, refinement can be introduced in the estimation of hazard and exposure, or both. In view of the variability associated with exposure modeling, it may often add more value to invest in realistic exposure data than in toxicity studies, apart from animal welfare considerations. © 2010 Elsevier Inc.
Subject
Biology
Biomedical Research
Grouping
REACH
Read-across
Risk assessment
Tiered exposure assessment
1 methoxypropan 2 ol
chemical compound
unclassified drug
analytic method
article
chemical analysis
data analysis
European Union
experimental animal welfare
health hazard
occupational exposure
physical chemistry
priority journal
qualitative analysis
quantitative analysis
risk assessment
standardization
statistical model
toxicity testing
Animalia
To reference this document use:
http://resolver.tudelft.nl/uuid:db146651-64e2-40d0-a467-377a53c4843c
TNO identifier
409232
ISSN
0273-2300
Source
Regulatory Toxicology and Pharmacology, 58 (1), 64-71
Document type
article