Harmonization Project Document No . 2 CHEMICAL-SPECIFIC ADJUSTMENT FACTORS FOR INTERSPECIES DIFFERENCES AND HUMAN VARIABILITY : GUIDANCE DOCUMENT FOR USE OF DATA IN DOSE / CONCENTRATION – RESPONSE ASSESSMENT

The overall objectives of the IPCS are to establish the scientific basis for assessment of the risk to human health and the environment from exposure to chemicals, through international peer review processes, as a prerequisite for the promotion of chemical safety, and to provide technical assistance in strengthening national capacities for the sound management of chemicals. Organisation for Economic Cooperation and Development (Participating Organizations), following recommendations made by the 1992 UN Conference on Environment and Development to strengthen cooperation and increase coordination in the field of chemical safety. The purpose of the IOMC is to promote coordination of the policies and activities pursued by the Participating Organizations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment. WHO Library Cataloguing-in-Publication Data Chemical-specific adjustment factors for interspecies differences and human variability : guidance document for use of data in dose/concentration-response assessment.

[1]  A. Renwick Data-derived safety factors for the evaluation of food additives and environmental contaminants. , 1993, Food additives and contaminants.

[2]  Arun Sharma Evaluation of certain food additives and contaminants. , 2001, World Health Organization technical report series.

[3]  Ipcs,et al.  Principles for the assessment of risks to human health from exposure to chemicals , 1999 .

[4]  Tim Morris,et al.  Physiological Parameters in Laboratory Animals and Humans , 1993, Pharmaceutical Research.

[5]  K Walton,et al.  Human variability in xenobiotic metabolism and pathway-related uncertainty factors for chemical risk assessment: a review. , 2005, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[6]  A G Renwick,et al.  Human variability and noncancer risk assessment--an analysis of the default uncertainty factor. , 1998, Regulatory toxicology and pharmacology : RTP.

[7]  M Younes,et al.  IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis. , 2001, Regulatory toxicology and pharmacology : RTP.

[8]  REVISED OPINION ON CYCLAMIC ACID AND ITS SODIUM AND CALCIUM SALTS ( Expressed on 9 March 2000 ) , 2022 .

[9]  K Walton,et al.  Species-specific uncertainty factors for compounds eliminated principally by renal excretion in humans. , 2004, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[10]  W. Slob,et al.  Mathematical modelling and quantitative methods. , 2002, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[11]  D J Rance,et al.  The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. , 1997, The Journal of pharmacology and experimental therapeutics.

[12]  K Walton,et al.  Human variability in polymorphic CYP2D6 metabolism: is the kinetic default uncertainty factor adequate? , 2002, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[13]  Ipcs,et al.  Assessing human health risks of chemicals; derivation of guidance values for health based exposure limits , 1994 .

[14]  A. Renwick,et al.  The use of surrogate endpoints to assess potential toxicity in humans. , 2001, Toxicology letters.

[15]  G. L. Kedderis,et al.  Incorporating human interindividual biotransformation variance in health risk assessment. , 2002, The Science of the total environment.

[16]  K Walton,et al.  Pathway-Related Factors: The Potential for Human Data to Improve the Scientific Basis of Risk Assessment , 2001 .

[17]  L. Lave Risk Assessment and Management , 2013, Advances in Risk Analysis.