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Chlorpyrifos CI CI CI N O O O C 2H5 C 2H5 P Chlorpyrifos is an organophosphorus insecticide used for the control of various crop pests in soil and on foliage, household pests and aquatic larvae. C N S 2 Physiochemical Properties Vapour pressure 2.49 x 103 Pa at 250C Water Solubility 2 mgL at 250C Log octanolwater 4.82 5.11 (high) partition coefficient ƒ tightly absorbed by soil and is not expected to leach sig ynificantly ƒ persists in soil for 60 to 120 days ƒ rate of hydrolysis in water with pH and temperature, and is enhanced by the presence of copper ƒ between 30 and 60% of the total amount of chlorpyrifos in an aqueous phase may disappear within 24 hours, through adsorption, degradation and vaporization5 General Toxicology of Chlorpyrifos ƒ chlorpyrifos is a cholinesterase inhibitor ƒ it is readily absorbed from the gastrointestinal tract and is rapidly metabolized ƒ metabolites are excreted in the urine and to a l i h fesser extent in the feces ƒ the main metabolites are 3,5,6trichloro2 pyridylphosphate and 3,5,6trichloropyridinol ƒ small amounts of unmetabolized chlorpyrifos have been detected in the blood, brain, and liver after accidental human ing

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CI

CI

CI

O

O C2H5

C2H5 P

Chlorpyrifos is an organophosphorus

insecticide used for the control of various

crop pests in soil and on foliage, household

pests and aquatic larvae.

S

2 5

Physiochemical Properties

Vapour pressure 2.49 x 10 -3 Pa at 25 0 C Water Solubility 2 mg/L at 25 0 C Log octanol-water 4.82 - 5.11 (high) partition coefficient

ƒ tightly absorbed by soil and is not expected to leach significantly g y

ƒ persists in soil for 60 to 120 days

ƒ rate of hydrolysis in water with pH and temperature, and is enhanced by the presence of copper

ƒ between 30 and 60% of the total amount of chlorpyrifos in an aqueous phase may disappear within 24 hours, through adsorption, degradation and vaporization

Residue limits have been set for exposure to

chlorpyrifos through both food and water by a

Chlorpyrifos Exposure

series of laboratory exposure studies

General Toxicology of Chlorpyrifos

ƒ chlorpyrifos is a cholinesterase inhibitor

ƒ it is readily absorbed from the gastrointestinal

tract and is rapidly metabolized

ƒ metabolites are excreted in the urine and to a

lesser extent in the feces

ƒ the main metabolites are

3,5,6-trichloro-2-pyridylphosphate and 3,5,6-trichloro-pyridinol

ƒ small amounts of unmetabolized chlorpyrifos have

been detected in the blood, brain, and liver after accidental human ingestion

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Toxicological Studies

Teratogenicity/Reproduction

ƒ chlorpyrifos was not teratogenic to mice at doses up to

and including 25 mg/kg bw/day, although severe

maternal toxicity and fetotoxicity were evident at that

dose

ƒ some malformations were observed among litters of

mice given 1 mg/kg chlorpyrifos; however, a

dose-related teratogenic response was not observed, nor

repeated in additional mice given the same dose

ƒ no evidence of a teratogenic response was observed in

mice given 0.1, 1, 10 or 25 mg/kg of chlorpyrifos during

the critical period of organogenesis

From Deacon et al 1979

Teratogenicity/Reproduction

ƒ reproduction performance was not affected by

chlorpyrifos at any dose level administered to mice

ƒ fetotoxicity, as evidenced by increased occurrence of

minor skeletal variants, and decreased fetal body weight measurements was noted at a dose level of 25 /k d i i

mg/kg dose in mice

Neurotoxicity

ƒ groups of rats were administered chlorpyrifos orally at

dosage levels of 0, 0.5, 1, 5, 10, 50 or 100 mg/kg/day

ƒ 28- 40% plasma cholinesterase inhibition (ChEI) was

observed 3-6 hours post exposure with chlorpyrifos

doses of 1 mg/kg/day or higher

ƒ Significant brain ChEI was observed with doses of Significant brain ChEI was observed with doses of

greater than 10 mg/kg/day

ƒ The NOAEL was determined to be 0.5 mg/kg/day

Neurotoxicity

ƒ groups of adult hens were administered chlorpyrifos

orally at dosage levels of 0, 25, 50, 100, 200 or 400 mg/kg bw/day, with atropine (30 mg/kg) being given to all birds prior to dosing

ƒ there were dose-dependent, acute cholinergic effects

observed for the chlorpyrifos treated groups Symptoms

i l d d included:

- transient signs of ataxia

- CNS depression and paralysis (reversible)

ƒ histologic evaluation revealed no evidence of neurotoxic

effects in chlorpyrifos treated hens

ƒ the acute dose of 100 mg/kg bw/day of chlorpyrifos did

not induce a delayed neurotoxic response in hens

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ƒ groups of CD-1 mice were fed chlorpyrifos in the diet at dosage

levels of 0, 0.05, 0.5 and 1.5 mg/kg/day for a period of 105 weeks

ƒ histological examination revealed a significant difference between

control and mid-dose males for the incidence of hyperplastic

nodules of the liver

ƒ there was a significant increase in the incidence of spindle cell

hyperplasia of the adrenal gland for male mice at low and mid-dose

levels, and in female mice at low dose

ƒ there were no other significant lesions or increased hyperplastic

and/or nodular lesions

ƒ the results of this study demonstrate that chlorpyrifos is not

oncogenic in mice at a dietary level up to and including 1.5

mg/kg/day

ƒ human volunteers were administered oral doses of

0.014 mg/kg bw/day of chlorpyrifos for 27 days, 0.03 mg/kg bw/day for 20 days or 0.10 mg/kg bw/day for nine days

ƒ red blood cell cholinesterase activity was not

affected at any level

Short-Term Toxicity

affected at any level

ƒ in a more recent study, human volunteers were administered a

single 0.5 mg/kg oral dose of chlorpyrifos, followed two or more

weeks later by a 0.5 or 5.0 mg/kg dermal dose of chlorpyrifos

ƒ no signs or symptoms of toxicity or changes in erythrocyte

cholinesterase were observed

ƒ plasma cholinesterase was depressed to 15% of predose levels by

Short-Term Toxicity

plasma cholinesterase was depressed to 15% of predose levels by

the 0.5 mg/kg oral dose, but was essentially unchanged following

the 5.0 mg/kg dermal dose

ƒ 0.5 mg/kg was considered a NOE(A)L for cholinergic signs in

humans, because all studies in laboratory animals indicate that

extensive inhibition of both RBC and plasma cholinesterase occur

before there are any actual expressions of cholinergic signs

ƒ Beagle dogs were fed diets containing chlorpyrofos at

dose levels of 0, 0.01, 0.03, 0.1, 1, or 3 mg/kg bw/day for two years

ƒ red blood cell cholinesterase was inhibited in males and

females at 0.1, 1.0 and 3.0 mg/kg bw/day

ƒ in a similar study, rats were fed diets containing

Chronic Toxicity

in a similar study, rats were fed diets containing chlorpyrifos at concentrations of 0, 0.01, 0.03, 0.1, 1 and

3 mg/kg bw/day for two years

ƒ brain cholinesterase activity was inhibited at 3.0 mg/kg

bw/day, and slightly depressed at 1.0 mg/kg bw/day

ƒ based on these results, the no-observed-adverse- effect

level (NOAEL) for red blood cell and brain cholinesterase inhibition is considered to be 0.1 mg/kg bw/day

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Chlorpyrifos Study NOAEL Endpoint

mg/kg/day Short-term toxicity (human) 0.1 AChE depr.

(human) 0.5 Chol Symp

(monkey) 0.1 AChE depr.

Chronic toxicity (dog) 0.03 AChE depr.

(rat) 0.1 AChE depr.

Reproduction (mouse) 1.0 Implantation, resorption sites

and live young Teratology (mouse) 25 Malformations

Neurotoxicity (rats) 0.5 AChE depr.

Carcinogenicity (mouse) 1.5 Tumorgenicity

aRfD = NO(A)EL

Uncertainty Factor The aRfD for methidathion has been derived by the U.S

EPA as follows:

Acute Reference Dose for Chlorpyrifos

aRfD = 0.5 mg/kg/day

100 where:

ƒ 0.5 mg/kg/day is the NOAEL derived from the neurotoxicity study in rats

ƒ 100 is the uncertainty factor

= 0.005 mg/kg/day

Acute Population Adjusted Dose

for Chlorpyrifos

ƒ The EPA found that in the case of chlorpyrifos the

default FQPA Safety Factor of 10 was required

ƒ Therefore, the acute Population Adjusted Dose (aPAD)is:

aPAD = aRfD

10

= 0.005 mg/kg/day = 0.0005 mg/kg/day

10

cRfD = NO(A)EL

Uncertainty Factor The cRfD for chlorpyriofs has been derived by the U.S

EPA as follows:

Chronic Reference Dose for Chlorpyrifos

cRfD = 0.03 mg/kg/day

100 where:

ƒ 0.03 mg/kg/day is the NOAEL derived from the chronic toxicity study in dogs

ƒ 100 is the uncertainty factor

= 0.0003 mg/kg/day

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Chronic Population Adjusted

Dose for Chlorpyrifos

ƒ Once again the FQPA Safety Factor of 10 has been

applied in calculating the chronic Population Adjusted

Dose (cPAD)

cPAD = aRfD

10

= 0.0003 mg/kg/day = 0.00003 mg/kg/day

10

Acute Dietary Risk Assessment

ƒ A revised acute dietary risk analysis was conducted

with the DEEM

ƒ The exposure at a maximum was to children (1-6 years

old) - 0.00041 mg/kg/day (99.9 th percentile of exposure)

aPAD = 0.0005 mg/kg/day and the Maximum 99.9 th percentile of exposure (acute food exposure) = 0.00041 mg/kg/day

aPAD > Acute food exposure, therefore the use is considered safe.

Chronic Dietary Risk Assessment

ƒ A chronic dietary risk analysis was conducted using the

DRES analysis

ƒ Using DRES, the Theoretical Maximum Daily Intake

(TMDI) was calculated, however it did incorporate data

from % treated crop, anticipated residue data and

market basket survey data

cPAD = 0.00003 mg/kg/day and the

TMDI = 0.0000153mg/kg/day

PAD > TMDI, therefore the use is considered safe.

y

Dietary Risk from Drinking Water

• The EPA determines the dietary risk based on modeling or from monitoring data from both surface and ground water

• To determine the maximum allowable contribution

of water-containing pesticide residues permitted in

of water containing pesticide residues permitted in the diet, EPA first looks at the risk from food and then determines a “drinking water level of comparison” (DWLOC) to determine whether modeled or monitoring levels exceed this level

• The DWLOC is the maximum concentration in drinking water which, when considered together with food exposure, does not exceed the PAD

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• For acute risk, the potential drinking water exposure

derived from either ground or surface water was

modeled resulting in an Estimated Environmental

Concentration (EEC) of 0.4 ppb for surface water

• Actual concentrations of chlorpyrifos in surface water

and finished drinking water are likely to be less

Acute Risk from Drinking Water

Acute Risk from Drinking Water

Calculating the DWLOC

= 0 0005 – 0 00041 (child 1-6 yrs) 0.0005 0.00041 (child, 1 6 yrs)

= 0.00009 mg/kg/day or 0.9 ppb

In comparing the DWLOC (0.9 ppb) with the EEC (0.4 ppb):

DWLOC > EEC, therefore the use is considered to be safe

Chronic Risk from Drinking

Water

• For chronic risk, the potential drinking water exposure

derived from either ground or surface water was

modeled resulting in an Estimated Environmental

Concentration (EEC) of 0.026 ppb for surface water ( ) pp

Chronic Risk from Drinking

Water

Calculating the DWLOC

= 0 00003 – 0 0000153 (child 1-6 yrs) 0.00003 0.0000153 (child, 1 6 yrs)

= 0.0000147 mg/kg/day or 14.7 ppb

In comparing the DWLOC (14.7 ppb) with the EEC (0.026 ppb):

DWLOC > EEC, therefore the use is considered to be safe

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