OECD

Question 1

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

Answer 1

ACUTE TOXICITY TESTS

Question 2

ACUTE TOXICITY TESTS endpoint

Answer 2

Death and signs of toxicity

Question 3

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

Answer 3

• 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

Question 4

Problems in extrapolation from experimental animals to humans:

Answer 4

• Differences in
• metabolic pathways * dermal penetration * mode of action

Question 5

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

Answer 5

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

Question 6

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

Answer 6

Acute oral testing

Question 7

This focuses on the Timing of lethality following acute chemical exposure

Answer 7

Acute oral testing

Question 8

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

Answer 8

Acute oral testing

Question 9

Logarithmic expansion from a starting dose

Answer 9

CLASSICAL LD50 TEST

Question 10

CLASSICAL LD50 TEST starting dose

Answer 10

10 mg/kg.

Question 11

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

Answer 11

True

Question 12

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

Answer 12

expensive and time consuming

Question 13

OECD methods are employed to

Answer 13

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

Question 14

Aims to identify the appropriate hazard class for new chemicals

Answer 14

FIXED DOSE PROCEDURE

Question 15

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

Answer 15

True

Question 16

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

Answer 16

True

Question 17

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

Answer 17

toxicity; sensitive

Question 18

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

Answer 18

True

Question 19

Aims to identify the appropriate hazard and labeling classification

Answer 19

ACUTE TOXIC CLASS METHOD

Question 20

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

Answer 20

ACUTE TOXIC CLASS METHOD

Question 21

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

Answer 21

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

Question 22

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.

Answer 22

survival or mortality

Question 23

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

Answer 23

survive or die

Question 24

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

Answer 24

UP AND DOWN PROCEDURE

Question 25

The dosage depends on whether the previously dosed animal lives or dies.

Answer 25

UP AND DOWN PROCEDURE

Question 26

This test provides a point estimate of lethality and confidence intervals and can be used to evaluate lethality up to 5000 mg/kg.

Answer 26

UP AND DOWN PROCEDURE

Question 27

UP AND DOWN PROCEDURE is a equential limit test uses up to __________ animals.

Answer 27

five

Question 28

in UP AND DOWN PROCEDURE Default dose spacing is

Answer 28

3.2 times the previous dose.

Question 29

The starting dose should be slightly below the estimated LD50

Answer 29

UP AND DOWN PROCEDURE

Question 30

In UP AND DOWN PROCEDURE, If no data are available to estimate the LD50, the starting dose is

Answer 30

175 mg/kg