Replacing the no-effect level (NOEL) with bounded effect levels (OBEL and LEBEL)

Statistics in Medicine

Volumn 21, Issue 20, 2002, Pages 3071-3078

  Hansson, Sven Ove ^a  

^a ROYAL INSTITUTE OF TECHNOLOGY   (Sweden)

Author keywords

Bounded effects level; LEBEL; No effect level; NOEL; OBEL; Type II errors

Indexed keywords

TRICHLOROETHYLENE;

ANALYTICAL ERROR; ARTICLE; CONCENTRATION RESPONSE; DATA ANALYSIS; DECISION MAKING; EXPERIMENTATION; EXPOSURE; LIVER DISEASE; MATHEMATICAL COMPUTING; MESOTHELIOMA; OBSERVATION; RESPIRATORY TRACT CANCER; RISK ASSESSMENT; SAFETY;

ANIMALS; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; FATTY LIVER; HUMANS; INHALATION EXPOSURE; MESOTHELIOMA; NO-OBSERVED-ADVERSE-EFFECT LEVEL; OCCUPATIONAL EXPOSURE; RESPIRATORY TRACT NEOPLASMS; SOLVENTS; TOXICITY TESTS;

EID: 0037202108     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1220     Document Type: Article

References (23)

1. Dourson ML, Stara JF. Regulatory history and experimental support of uncertainty (safety) factors. Regulatory Toxicology and Pharmacology, 1983; 3: 224-238.
2. Weil CS. Statistics vs safety factors and scientific judgment in the evaluation of safety for man. Toxicology and Applied Pharmacology, 1972; 21: 454-463.
3. Barnes DG, Dourson M. Reference dose (RfD): description and use in health risk assessments. Regulatory Toxicology and Pharmacology 1988; 8: 471-486.
4. Marshall E. EPA's high-risk carcinogen policy. Science 1982; 218: 975-978.
5. Renwick AG. The use of an additional safety or uncertainty factor for nature of toxicity in the estimation of acceptable daily-intake and to tolerable daily intake values. Regulatory Toxicology and Pharmacology 1995; 22: 250-261.
6. Hansson SO. Critical effects and exposure limits. Risk Analysis 1997; 17: 227-236.
7. Hansson SO. Setting the Limit. Occupational Health Standards and the Limits of Science. Oxford University Press, 1998.
8. Zielhuis RL, van der Kreek FW. The use of a safety factor in setting health based permissible levels for occupational health. I. A proposal. International Archives of Occupational and Environmental Health 1979; 42:191-201.
9. Crump KS. A new method for determining allowable daily intakes. Fundamental and Applied Toxicology 1984; 4:854-871.
10. Brown KG, Erdreich LS. Statistical uncertainty in the no-observed-adverse-effect level. Fundamental and Applied Toxicology 1989; 13:235-244.
11. Leisenring W, Ryan L. Statistical properties of the NOAEL. Regulatory Toxicology and Pharmacology 1992; 15:161-171.
12. Haag-Grönlund M, Fransson-Steen R, Victorin K. Application of the benchmark method to risk assessment of trichloroethene. Requlatory Toxicology and Pharmacology 1995; 21:261-269.
13. Mantel N, Bryan WR. 'Safety' testing of carcinogenic agents. Journal of the National Cancer Institute 1961; 27:455-470.
14. Mantel N, Schneiderman MA. Estimating 'safe' levels, a hazardous undertaking. Cancer Research 1975; 35: 1379-1386.
15. Gaylor DW. Quantitative risk analysis for quantal reproductive and developmental effects. Environmental Health Perspectives 1989; 79:243-246.
16. Hansson SO. The detection level. Regulatory Toxicology and Phamacology 1995; 22:103-109.
17. Gardner. MJ, Altman DG. Statistics with Confidence. Confidence Intervals and Statistical Guidelines. British Medical Journal: London, 1989; 29.
18. Crawford. M, Wilson R. Low-dose linearity: the rule or the exception? Human and Ecological Risk Assessment 1996; 2:305-330.
19. Diem H (ed.). Chloressigsäuremethylester. Gesundheitsschädliche Arbeitsstoffe. Toxikologisch-arbeits-medizinische Begründung von MAK-Werten (Maximale Arbeitsplatzkonzentrationen). (Senatskommission zur Prüfung gesundheitsschädlicher Arbetsstoffe der Deutschen Forschungsgemeinschaft", München), Lieferung 20, 1994.
20. Bailar JC, Crouch EAC, Shaik R, Spiegelman D. One-hit models of carcinogenesis: conservative or not? Risk Analysis 1988; 8:485-497.
21. Bailar, JC, Crouch EAC, Spiegelman D, Shaikh R. Response to Park. Risk Analysis 1990; 10:211-212.
22. Park CN. 'Underestimation' of linear models. Risk Analysis 1990; 10:209-210.
23. Sielken RL. Driving cancer dose-response modeling with data, not assumptions. Risk Analysis 1990; 10: 207-208.