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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