Comparison of points of departure between subchronic and chronic toxicity studies on food additives, food contaminants and natural food constituents.

[1]  H. Spielmann,et al.  Use of the dog as non-rodent test species in the safety testing schedule associated with the registration of crop and plant protection products (pesticides): present status , 2005, Archives of Toxicology.

[2]  Paul Tobback,et al.  European Commission Health & Consumer Protection Directorate-general Directorate C -scientific Opinions C2 -management of Scientific Committee; Scientific Co-operation and Networks Guidance on Submissions for Food Additive Evaluations by the Scientific Committee on Food Contents Introductory Remarks , 2022 .

[3]  C. S. Weil,et al.  Safety Evaluation of Chemicals, Relationship between Short-and Long-Term Feeding Studies in Designing an Effective Toxicity Test , 1963 .

[4]  Barbara E Engeli,et al.  Study parameters influencing NOAEL and LOAEL in toxicity feeding studies for pesticides: exposure duration versus dose decrement, dose spacing, group size and chemical class. , 2011, Regulatory toxicology and pharmacology : RTP.

[5]  Sebastian Hoffmann,et al.  Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats. , 2009, Regulatory toxicology and pharmacology : RTP.

[6]  G Nano,et al.  [Chemical risk assessment]. , 2010, Giornale italiano di medicina del lavoro ed ergonomia.

[7]  J. Schlatter,et al.  The significance of the subchronic toxicity in the dietary risk assessment of pesticides. , 2010, Regulatory toxicology and pharmacology : RTP.

[8]  Katy Taylor,et al.  The added value of the 90-day repeated dose oral toxicity test for industrial chemicals with a low (sub)acute toxicity profile in a high quality dataset. , 2014, Regulatory toxicology and pharmacology : RTP.

[9]  Wout Slob,et al.  A comparison of ratio distributions based on the NOAEL and the benchmark approach for subchronic-to-chronic extrapolation. , 2005, Toxicological sciences : an official journal of the Society of Toxicology.

[10]  Andreas Karwath,et al.  Time extrapolation in regulatory risk assessment: The impact of study differences on the extrapolation factors. , 2020, Regulatory toxicology and pharmacology : RTP.

[11]  Alexandra Maertens,et al.  Analysis of Public Oral Toxicity Data from REACH Registrations 2008–2014 , 2016, ALTEX.

[12]  W Slob,et al.  Assessment factors for human health risk assessment: a discussion paper. , 1999, Critical reviews in toxicology.

[13]  J. Zarn,et al.  Current pesticide dietary risk assessment in light of comparable animal study NOAELs after chronic and short-termed exposure durations , 2017, Archives of Toxicology.

[14]  K. Taylor,et al.  The added value of the 90‐day repeated dose oral toxicity test for industrial chemicals with a low (sub)acute toxicity profile in a high quality dataset: An update , 2017, Regulatory toxicology and pharmacology : RTP.

[15]  V J Feron,et al.  Sub‐acute versus sub‐chronic oral toxicity study in rats: Comparative study of 82 compounds , 1984, Journal of applied toxicology : JAT.

[16]  A. Boobis,et al.  Target organ profiles in toxicity studies supporting human dosing: Does severity progress with longer duration of exposure? , 2015, Regulatory toxicology and pharmacology : RTP.

[17]  H R Pohl,et al.  Chemical risk assessment and uncertainty associated with extrapolation across exposure duration. , 2010, Regulatory toxicology and pharmacology : RTP.

[18]  M. Pieters,et al.  Evaluation of the uncertainty factor for subchronic-to-chronic extrapolation: statistical analysis of toxicity data. , 1998, Regulatory toxicology and pharmacology : RTP.

[19]  Kimmo Louekari,et al.  Alternative acute oral toxicity assessment under REACH based on sub-acute toxicity values. , 2017, ALTEX.

[20]  S. Kuppusamy,et al.  A quantitative comparison of points of departure between 28‐day and 90‐day repeated dose studies with a proposed extrapolation factor , 2018, Regulatory toxicology and pharmacology : RTP.

[21]  W Slob,et al.  Conversion factors estimating indicative chronic no-observed-adverse-effect levels from short-term toxicity data. , 1996, Regulatory toxicology and pharmacology : RTP.

[22]  P. Galtier,et al.  Calcium ascorbate, magnesium ascorbate and zinc ascorbate added for nutritional purposes in food supplements 1 Scientific Opinion of the Panel on Food Additives and Nutrient Sources added to Food , 2009 .

[23]  Barbara E Engeli,et al.  Characterization of the dose decrement in regulatory rat pesticide toxicity feeding studies. , 2013, Regulatory toxicology and pharmacology : RTP.

[24]  Angelo Moretto,et al.  A Tiered Approach to Systemic Toxicity Testing for Agricultural Chemical Safety Assessment , 2006, Critical reviews in toxicology.

[25]  Sally Robinson,et al.  Target organ profiles in toxicity studies supporting human dosing: an assessment of recovery and chronic dosing. , 2014, Regulatory toxicology and pharmacology : RTP.

[26]  I Mangelsdorf,et al.  Evaluation of time extrapolation factors based on the database RepDose. , 2011, Toxicology letters.

[27]  F Kalberlah,et al.  Time extrapolation and interspecies extrapolation for locally acting substances in case of limited toxicological data. , 2002, The Annals of occupational hygiene.

[28]  S Jacobi,et al.  REPDOSE: A database on repeated dose toxicity studies of commercial chemicals--A multifunctional tool. , 2006, Regulatory toxicology and pharmacology : RTP.

[29]  Richard W. Lewis,et al.  A 1-year toxicity study in dogs is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides , 2010, Critical reviews in toxicology.

[30]  W. H. Butler,et al.  Long-term toxicity study of amaranth in rats using animals exposed in utero. , 1987, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[31]  M. Gamo,et al.  Investigation of organ-specific assessment factors related to sub-acute and sub-chronic toxicity studies , 2014 .

[32]  B. Hakkert,et al.  Extrapolation for Exposure Duration in Oral Toxicity: A Quantitative Analysis of Historical Toxicity Data , 2004 .

[33]  Guidance on information requirements and chemical safety assessment , 2008 .

[34]  Wout Slob,et al.  A retrospective analysis of the added value of the rat two-generation reproductive toxicity study versus the rat subchronic toxicity study. , 2007, Reproductive toxicology.

[35]  Wout Slob,et al.  A retrospective analysis of the two-generation study: what is the added value of the second generation? , 2007, Reproductive toxicology.

[36]  R. Woutersen,et al.  Is current risk assessment of non-genotoxic carcinogens protective? , 2018, Critical reviews in toxicology.

[37]  H. Spielmann,et al.  The use of dogs as second species in regulatory testing of pesticides , 2001, Archives of Toxicology.

[38]  V. Dellarco,et al.  A retrospective analysis of toxicity studies in dogs and impact on the chronic reference dose for conventional pesticide chemicals , 2010, Critical reviews in toxicology.

[39]  Sally Robinson,et al.  Target organ toxicities in studies conducted to support first time in man dosing: an analysis across species and therapy areas. , 2013, Regulatory toxicology and pharmacology : RTP.

[40]  R. Tibshirani,et al.  (37) Medications as Independent Risk Factors of Delirium in Patients With COVID-19: A Retrospective Study , 2018, Journal of the Academy of Consultation-Liaison Psychiatry.

[41]  Wout Slob,et al.  Derivation of conversion factors to estimate an indicative chronic NOAEL from short-term toxicity data , 1995 .