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)
BIOSOLUBILITY
Solubility of inhaled particles has great implication on its mode of action and subsequent risk assessment thereof. The term "poorly soluble particles”, is often used without being specified. Further to the definition given in Section 1.3, we aim to give some guidance for the applicability of this term in this chapter.