Risk assessment Flashcards

1
Q

What is the definition of Risk Assessment?

A

Process in which the hazard and risks of negative effects on humans
and/or the environment as a result of exposure to substances are
evaluated

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2
Q

What is a hazard?

A

something that has the potential to cause unwanted consequences

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3
Q

What is a risk?

A

the chance that undesirable consequences will occur

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4
Q

How is risk calculated?

A

Risk = hazard x exposure

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5
Q

What is researched with a hazard assessment?

A

Has the compound the potency to
cause an adverse effect?

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6
Q

What is researched with a Dosis-effect assessment?

A

What is the relationship between
the dose and manifestation of
the effect in humans?

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7
Q

What 3 assessment does risk assessment consist of?

A

Hazard assessment
Dosis-effect assesment
exposure assessment

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8
Q

What does risk characterisation determine?

A

The estimated
occurrence of a
negative effect in a
given population

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9
Q

What aspects determine experience of risks?

A

-risk of health damage
-consequences of health damage
-voluntary exposure
-attention in media
-trust in responsible authorities

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10
Q

What is LD50?

A

Dose at which 50% lethality occurs
(=acute toxicity value)

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11
Q

What are the 2 classification types of substances?

A
  • non-genotoxic substances = threshold
    -genotoxic carcinogens = non-threshold
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12
Q

What are steps to derive a standard for threshold?

A
  1. Toxicity tests
  2. Point of Departure (PoD)
  3. Establish critical effect
  4. From PoD to standard
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13
Q

What is the purpose of a chronic test?

A

estimate NOAEL

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14
Q

What is TDI?

A

Tolerable Daily Intake
- unavoidable compounds

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15
Q

What is ADI?

A

Acceptable Daily Intake
- avoidable compounds

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16
Q

Wat is de formule voor TDI?

A

NOAEL / UF x UF
(UF = uncertainty factors)

17
Q

What are 4 uncertainty factors?

A

Semichronic => chronic
- LOAEL => NOAEL
- Limited dataset
- Type laboratory animal

18
Q

What are disadvantages of NOAEL?

A
  1. NOAEL must be one of the doses tested
  2. Except NOAEL, the rest of the dose response curve is ignored
19
Q

What is an alternative to NOAEL?

A

BMD = Benchmark Dose

20
Q

What is BMD?

A

a dose or concentration that produces a predetermined change
in the response rate of an adverse effect

21
Q

What is MOE?

A

Margin of Exposure
MOE of 100 or more is safe

22
Q

What is the MOE formula?

A

TD10 / exposure dose

23
Q

What is the mutage of acrylamide?

A

Glycidamine

24
Q

What is MOS?

A

Margin of Safety = toxic value/dose

25
Q

What are uncertainties/considerations for risk assessment with animals?

A
  • Extrapolation animal -> humans
  • Different diet groups
  • other pathways
  • bioavailibility is lower in humans
  • humans metabolise less and excrete more = less exposure
26
Q

What is ED?

A

Effective Dose

27
Q

What is TD?

A

Toxic dose effect

28
Q

What is TI?

A

Therapeutic Index = measure of relative drug safety

29
Q

What is disadvantage of TI? What is a alternative?

A

Slope dose-respons curve ED and TD

MOS