Pesticide residues in food — 2006: Toxicological ... - ipcs inchem

312
Human
a
Dietary administration
b
Gavage administration
c
Highest tested dose
37 days
No inhibition of
0.025 c —
34 days cholinesterase in 0.03 c
28 days
erythrocytes
0.03 c
The Meeting reaffirmed the ARfD of 0.03 mg/kg bw established by the 2001 JMPR. This ARfD
was based on the NOAEL of 2.5 mg/kg bw identified in studies of acute toxicity and neurotoxicity in
rats, and a safety factor of 100. This ARfD was supported by the NOAEL of 0.21 mg/kg bw identified
in the study in humans given a single dose of diazinon, and a safety factor of 10.
Estimate of acceptable daily intake for humans
0–0.005 mg/kg bw
Estimate of acute reference dose
0.03 mg/kg bw
Information that would be useful for the continued evaluation of the compound
Results from epidemiological, occupational health and other such observational studies of
human exposure
References
Anderson, G.D. (2000) A randomized, double-blind ascending, acute, oral dose study of diazinon to determine the
no effect level (NOEL) for plasma and red blood cell cholinesterase activity in normal, healthy volunteers.
Unpublished report No. NCP-8373 from Covance Clinical Research Unit Inc., Madison, Wisconsin, USA.
Submitted to WHO by Huntingdon Research Centre Ltd, Huntingdon, Cambridgeshire, England on behalf
of Makhteshim Chemical Works Ltd, Beer-Sheva, Israel. Consistent with the Declaration of Helsinki, GCP
compliant 21 CFR 50, 54, 56, 312, 314 and GLP compliant.
Barnes, T.B., Arthur, A.T. & Hazelette, J.R. (1988) Diazinon (MG-8): 90-day oral toxicity study in dogs. Number
882012. Unpublished report prepared by Ciba-Geigy Corporation, Greensboro, NC, USA. Submitted to
WHO by Novartis Crop Protection AG, Basel, Switzerland. GLP statement provided.
Bathe, R. (1980) Acute oral LD 50
in the rat of technical G 24480. Number 800478. Unpublished report
from Ciba-Geigy Ltd, Sisseln, Switzerland. Submitted to WHO by Novartis Crop Protection AG, Basel,
Switzerland. Pre-GLP requirements.
Bathe, R. (1972a) Acute oral LD 50
of technical diazinon in the mouse. Number Siss 1679. Unpublished report
prepared by Ciba-Geigy Ltd, Sisseln, Switzerland. Submitted to WHO by Novartis Crop Protection AG,
Basel, Switzerland. Pre-GLP requirements.
Bathe, R. (1972b) Acute dermal LD 50
of technical diazinon (G-24480) in the rat. Number Siss 1679. Unpublished
report prepared by Ciba-Geigy Ltd, Sisseln, Switzerland. Submitted to WHO by Novartis Crop Protection
AG, Basel, Switzerland. Pre-GLP requirements.
Beilstein, P. (1998) Tolerance study in Novartis managers upon repeated oral administration of diazinon.
Unpublished report No. 972019. Novartis Crop Safety/Human Safety Assessment, CH-4002 Basel,
Switzerland Submitted to WHO by Huntingdon Research Centre Ltd, Huntingdon, Cambridgeshire,
DIAZINON X-X JMPR 2006