Technical Report 122
- Pages
- Summary
- INTRODUCTION
- PHYSICO-CHEMICAL ASPECTS ASSOCIATED WITH `LUNG OVERLOAD`
- BIOSOLUBILITY
- PATHOBIOLOGY OF ʽLUNG OVERLOADʼ
- SPECIES DIFFERENCES AND MECHANISMS OF LUNG TUMOuR FORMATION IN RATS
- Subchronic inhalation studies
- Chronic inhalation studies
- Other mammalian species responses to inhaled particulates
- Understanding the mechanisms of the unique neoplastic rat lung responses to particle overload
- Conclusions
- Adverse outcome pathway
- Relevance of `Lung Overload` for humans
- Biomathematical modelling of respirable dust in human lungs
- INFLUENCE OF METHODOLOGY USED
- HUMAN DATA, INCLUDING EPIDEMIOLOGY
- REGULATORY CONSIDERATIONS
- Carcinogen classifications of relevance to inhalation exposure to PSP
- Other non-tumorigenic classifications of relevance to PSP inhalation exposure
- Proposed approaches to derive health based exposure limits for PSPs
- Conclusions on the rat lung overload issue from a regulatory perspective
- Recommendation from a regulatory perspective for classification and DNEL derivation
- CONCLUSIONS/DATA GAPS
- ABBREVIATIONS
- APPENDIX A: Test Methodology: BALF Study
- APPENDIX B: Derivation of a human no effect level (‘DNEL’) under REACH’
- BIBLIOGRAPHY
- MEMBERS OF THE TASK FORCE
- MEMBERS OF THE SCIENTIFIC COMMITTEE
- MEMBERS OF THE SCIENTIFIC COMMITTEE (cont’d)