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Table 2 Studies involving human volunteers evaluated by the JMPR*

From: The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas

Compound Group Year Number of toxicity studies Number of ADME studies Used for ADI Used for ARfD Comments
Carbaryl Carb-amate 1996 3 1 (same study) NO NO Carcinogenicity in mice
Dimethoate OP 1996 1 (1967)   NO NO Reproductive toxicity
Mevinphos OP 1996 2 (1975)   YES YES SF of 20 because N = 8
Fenthion OP 1997 1 (1979)   YES (in 1995) NO Not suitable for ARfD because no effects in rats after a single much higher dose
Malathion OP 1997 1 (1962)   NO NO Old study, possibly containing impurities, NOAEL in rats much higher
Methidathion OP 1997 1 (1970)   NA YES SF of 10 despite N = 8 because supported by data in rats with a SF of 100
Amitraz   1998 3 (1984) 1 (1984) (same study) NA YES  
Dichloran   1998 1 (1962)   NO NA Supportive of data in dogs with a SF of 200 because of data gaps
Chlorpyrifos OP 1999 7 (1971-1999) 1 (1999) (same study) YES YES ADI based on data in animals with a SF of 100 and in humans with a SF of 10 (N = 4-6) giving the same ADI
Ethoprophos OP 1999 1 (1986) 1 (1986, same study) NA NA Study performed to assess occupational exposure
Permethrin Pyre-throid 1999   1 (1985) NO NA  
Fenitrothion OP 2000 3 (1968-1999) 1 (1999) (same study) NO YES Too short duration (4 days) for setting the ADI
Imazalil Azole 2000 1 (1979)   NO NA Skin irritation study
Diazinon OP 2001 2 (1999)   NA NO Only in male and studies in animals showed sex difference
Methomyl Carbamate 2001 1 (1998)   YES YES SF of 5 because of rapid reversibility of effects, used although N = 5 because supported by data in animals
Acephate OP 2002 2 (1972-2000) 1 (2000) (same study) NO NO Not used because brain AChE more sensitive to inhibition than RBC AChE
Ethephon   2002 3 (1971-1977)   NA YES  
Methamidophos OP 2002 2 (1973)   NO NO Studies considered supportive (giving similar ADI or ARfD)
Oxamyl Carb-amate 2002 1 (1999)   YES YES Although N = 5, data in animals were supportive
Oxydemeton methyl OP 2002 2 (1973)   NA NO Not used because of methodological problems
Tolylfluanid Sulf-amide fun-gicide 2002 1 (1968)   NA NA Skin irritation study
Triazophos OP 2002 4 (1971-1973)   YES YES N = 5-25, acceptable because performed according to the standard of the time
Malathion OP 2003 1 (2000) 1 (2000) (same study) NA YES N = 14
Paraquat   2003   1 (1984) NO NO Poor skin absorption
Phospmet OP 2003 1 (1999)   NA YES N = 12
Propiconazole Azole 2004 1 (1991   NA NA Study for skin sensitisation
Acephate OP 2005 2 (2000-2003) 2 (2000-2003) (same studies) YES YES N = 7-14, more data on brain vs RBC AChE allowed the use of human data. Comparative metabolism data also allowed the use of a chemical specific assessment factor
Pirimiphos-methyl OP 2006 2 (1974-1976)   NA NO Considered supportive since it would have given a slightly lower ARfD
Temephos OP 2006 1 (1967)   NA NO Poor quality of reporting
Thiabedazole Azole 2006 1 (1965)   NO NO Relevant parameters could not be assessed in humans
  1. * Note: malathion and acephate have been evaluated twice
  2. AChE = Acetyl Cholinesterase
  3. ADME = Absorption, Distribution, Metabolism and Excretion
  4. ADI = Acceptable Daily Intake
  5. ARfD = Acute Reference Dose
  6. NOAEL = No Observed Adverse Effect Level
  7. RBC = Red Blood Cell
  8. SF = Safety Factor