OECD Flashcards

(30 cards)

1
Q

Measures the adverse effects that occur within a short period of time

A

ACUTE TOXICITY TESTS

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2
Q

ACUTE TOXICITY TESTS endpoint

A

Death and signs of toxicity

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3
Q

Information gained from these ACUTE TOXICITY TESTS:

  • Basis for _________________
  • Identify the mode of ___________ of a substance
  • Information on ____________ associated with target-organ toxicity
  • For use in___________ and ___________t of toxic reactions in humans
A
  • Basis for hazard classification
  • Identify the mode of toxic action of a substance
  • Information on doses associated with target-organ toxicity
  • For use in diagnosis and treatment of toxic reactions in humans
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4
Q

Problems in extrapolation from experimental animals to humans:

A
  • Differences in
  • metabolic pathways * dermal penetration * mode of action
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5
Q

Advantages of using experimental animals in testing procedures:
* possibility of clearly defined ________________
* amenity to controlled ____________ and controlled _________________ of exposure
* possibility of ________________ examination of all tissues following necropsy

A
  • possibility of clearly defined genetic constitution
  • amenity to controlled exposure and controlled duration of exposure * possibility of detailed examination of all tissues following necropsy
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6
Q

This focuses on the Determination of the median lethal dose (LD50)

A

Acute oral testing

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7
Q

This focuses on the Timing of lethality following acute chemical exposure

A

Acute oral testing

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8
Q

This focuses on the Observation of the onset, nature, severity, and reversibility of toxicity

A

Acute oral testing

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9
Q

Logarithmic expansion from a starting dose

A

CLASSICAL LD50 TEST

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10
Q

CLASSICAL LD50 TEST starting dose

A

10 mg/kg.

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11
Q

T/F: In Classical LD50 Test, each dose level necessitates the use of a group of test animals

A

True

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12
Q

If many dose levels are to be tested, then the classical LD50 test presents the following disadvantages:

A

expensive and time consuming

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13
Q

OECD methods are employed to

A
  1. Decrease the number of animals necessary
  2. Reduce study duration
  3. Reduce the amount of test substance needed
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14
Q

Aims to identify the appropriate hazard class for new chemicals

A

FIXED DOSE PROCEDURE

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15
Q

T/F: FIXED DOSE PROCEDURE does not provide a point estimate of the LD50.

A

True

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16
Q

T/F: In Fixed Dose Procedure, Animals are tested sequentially at one of four doses (5, 50, 300, or 2000
mg/kg BW).

17
Q

In Fixed Dose Procedure, Once clear signs of ___________ appear, additional animals (females or the more ___________ sex) are dosed at that level

A

toxicity; sensitive

18
Q

T/F: In Fixed dose procedure, Subsequent groups of animals may receive doses at higher or lower levels, if necessary, depending on the outcome of the previous group

19
Q

Aims to identify the appropriate hazard and labeling classification

A

ACUTE TOXIC CLASS METHOD

20
Q

Provides a RANGE for lethality rather than a point estimate of the LD50

A

ACUTE TOXIC CLASS METHOD

21
Q

In ACUTE TOXIC CLASS METHOD, Groups of three animals receive one of the four or five doses:

A

5, 50,
300, 2000 and, if necessary, 5000 mg/kg body weight.

22
Q

In Acute toxic class method, Depending on the _________________ of the first group of animals, three or more animals may receive the same or a higher or lower dose.

A

survival or mortality

23
Q

The number of animals that ______________determines the classification decisions. in acute toxic class method

A

survive or die

24
Q

Employs sequential dosing, using only a single animal at each step.

A

UP AND DOWN PROCEDURE

25
The dosage depends on whether the previously dosed animal lives or dies.
UP AND DOWN PROCEDURE
26
This test provides a point estimate of lethality and confidence intervals and can be used to evaluate lethality up to 5000 mg/kg.
UP AND DOWN PROCEDURE
27
UP AND DOWN PROCEDURE is a equential limit test uses up to __________ animals.
five
28
in UP AND DOWN PROCEDURE Default dose spacing is
3.2 times the previous dose.
29
The starting dose should be slightly below the estimated LD50
UP AND DOWN PROCEDURE
30
In UP AND DOWN PROCEDURE, If no data are available to estimate the LD50, the starting dose is
175 mg/kg