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MGT 3302, Introduction to Project Management 1
Course Learning Outcomes for Unit V
Upon completion of this unit, students should be able to:
1. Describe the components of a basic project schedule.
1.1 Illustrate components of a project schedule, including a
Gantt chart and network activity
diagram.
Course/Unit
Learning Outcomes
Learning Activity
1.1
Unit Lesson
Chapter 6, pp. 214–232
Unit V Course Project
Required Unit Resources
Chapter 6: Resource Utilization, pp. 214–232
Unit Lesson
In this unit, we are discussing resource planning and resource
utilization, which goes hand-in-hand with
creating and managing a Gantt chart. In order to efficiently
manage our resources and make full use of our
Gantt chart, we need to have finalized our estimated durations
and our predecessors. In this unit’s
assignment, you will create a finalized list of activities with
durations and predecessors, a network activity
diagram based on that finalized list, and a Gantt chart.
As a reminder, for our fair project, the predecessors and
durations are shown below.
Activity # Description Predecessors Estimated
Duration (days)
A Determine some potential dates for the fair. None 5
B Research potential available locations for a
tent and space for 300 employees.
A 3
C Discuss potential locations and cost. B 2
D Decide on a location. C 1
E Reserve the location. D 4
F Research companies that have fun day
activities, such as dunking booths.
A 1
G Discuss potential activities and cost. F 1
H Reserve the activities. G 2
I Gather a list of all other items needed (e.g.,
tables, chairs, garbage cans).
E, N, H 7
J Research potential companies that will
provide food, including lunch and fun fair
food.
A 1
K Discuss food options and cost. J 2
L Determine a potential menu. K 1
M Determine a company to hire. L 1
N Order food. M 1
O Communicate fun day to all employees. I 1
UNIT V STUDY GUIDE
Resource Utilization
MGT 3302, Introduction to Project Management 2
UNIT x STUDY GUIDE
Title
Our simplified activity network sequence, based on those
predecessors, looks like the graphic below.
But, what if we had other constraints to consider? What if there
were only two people in our organization that
could perform activities B, F, and J? This would mean that we
have additional constraints on our resources
that we must plan for and manage.
Resource Planning
In resource planning, there are many approaches to establishing
a sequence for your activities. For example,
a technically constrained activity sequence is a sequence of
activities that takes technical constraints into
consideration. For example, you cannot design a new software
application until you have the requirements.
You cannot write the code until you have the technical specs
from the designer. So, one activity needs to be
complete before another activity begins. This is the general
basis of the current activity network sequencing
for our fair project.
There is also a resource-constrained activity sequence. This
means that the sequence of activities must take
resource constraints into consideration. As a reminder,
resources for the purposes of activity networks
generally refers to people who perform tasks. For example, let’s
assume that you have three activities that
can be performed concurrently or all at the same time. This is
great and certainly a timesaver, except for the
possibility that you only have two people who can perform
those tasks. What do you do then? The project
manager (PM) can only schedule two people at one time, so the
activity sequence is constrained, and the
third activity will have to occur after the first or second activity
is complete.
If this is the case, our activity network might change to
accommodate the fact that of the three starting
activities (i.e., B, F, and J), only two can occur at the same
time. Then, our new activity network sequence
might look something like the one shown below.
MGT 3302, Introduction to Project Management 3
UNIT x STUDY GUIDE
Title
Did you notice how we changed two of the three paths? Would
this change affect our critical path or expected
end date for this project? Let’s calculate and see.
To calculate the critical path, see the calculations below.
= 1+5+3+2+1+2+1 =
15 days
15 days
1+7+1+2+1+1+2+1 = 16 days
No, in this case, the critical path, which is path three, was not
changed. Had we chosen to rearrange our
paths differently though, we may have affected our critical path
and our estimated end date.
Resource Leveling
As already mentioned, the PM has to enter all of the pertinent
information into a Gantt chart. Once the PM
has done that, then adjustments may be made throughout the life
cycle of a project. But, how do we know
how the changes affect the end date of our project? The main
tool for understanding the end date of the
project is resource leveling. If the PM makes a change to a
predecessor, for example, then the PM can re-
level the resources and see how the change affects the end date.
As a reminder, below is a random example of a Gantt chart.
As you can see from this random Gantt chart example, the
resources have been leveled, and the project
estimated end date is February 24. The blue lines show us
whether activities are running concurrently or
sequentially. They also show us what we need to complete
before the next activity can start. If we had to
make a change to the duration, a change to the resource who is
performing a task, delete or add a task, or
change the predecessors, then once we clicked to “Level
Resources,” we would see a change in the blue
lines. We may also potentially see a change to the estimated end
date.
As Gido, Clements, and Baker (2018) note, resource leveling
also involves manipulating the start and finish
dates so that the PM can balance the demand for resources.
For example, in our fair project, we say that Activity J will take
7 days. Suppose the PM consults with the
resource, who, after 3.5 days, tells us he or she is 75% done. At
3.5 days, the resource should only be 50%
done. But, this is a positive thing, right? We are ahead of
schedule! The PM will enter information into the
Gantt chart indicating that the resource is 75% done. The PM
then clicks to level resources, and we might see
that our new project estimated end date is 2 days earlier. We use
the term might because other constraints
may be involved to prevent our project from completing 2 days
earlier. As a matter of fact, we might have just
added some slack time, and this change of 2 days does not
affect our critical path at all. Conversely, if the
resource should be 100% complete but is only 75% complete,
then it is obviously taking the resource more
MGT 3302, Introduction to Project Management 4
UNIT x STUDY GUIDE
Title
time to do the work than was originally estimated. This may
mean that the project will push out a couple of
days longer than expected.
Similarly, what if a resource approaches the PM and indicates
that his or her original estimate of the duration
of his or her activity was not correct? Then, the PM would need
to adjust that duration and re-level the
resources.
In projects, the term schedule slippage refers to missing a
project deadline. In larger projects, especially high-
profile projects like those you might find in the government,
schedule slippage could mean there are fees or
penalties assessed to the project organization. Also, we should
aim to use our resources and budget as
efficiently as possible. So, if we do not accurately estimate our
durations, then we might have to hire in
consultants to help, which is a costly endeavor.
What are some of the things that a PM can do if he or she
realizes that re-leveling resources causes the end
date to be moved out too far? As mentioned previously, we can
hire some contractors or authorize some
overtime for our resources. But, you can only expect a resource
to work so much before he or she gets tired
and quality is diminished. We can hire a new person, but there
will likely be a learning curve, and the cost of
hiring someone new is always high. If it is a technical resource,
we can send someone for training, but again,
that would take time and cost money. Is the cost or benefit
higher than the cost of the delayed project? We
can also reevaluate our predecessors and look for activities that
can occur concurrently rather than
sequentially.
Final note: One important tool that a PM can use is a resource
requirements plan (RRP). An RRP is simply a
plan for the expected utilization of resources. The PM will take
all constraints into consideration to create a
baseline schedule. These constraints could include items like a
limit to the total hours that a resource can
devote to the project or limits regarding when a resource needs
to complete the project. For example, one
resource may need to finish his or her activities in the first half
of the project. The RRP is simply a tool or plan
to help the PM keep up with the resource constraints for a
project.
Reference
Gido, J., Clements, J. P., & Baker, R. (2018). Successful project
management (7th ed.). Boston, MA:
Cengage Learning.
Suggested Unit Resources
In order to access the following resources, click the links
below.
The following video provides an example of using resource
capacity in Microsoft Project.
Howard, B. (2018, February 6). Resource capacity vs work in
MS Project [Video file]. Retrieved from
https://www.youtube.com/watch?v=jVPJShkdJxE
Transcript for Resource Capacity vs Work in MS Project video
The video below discusses how to manage resource utilization.
Springhouse Education & Consulting. (2014, June 24). Monitor
effective resource usage in Microsoft Project
Professional 2013 [Video file]. Retrieved from
https://www.youtube.com/watch?v=q5sPDJ66oL8
Transcript for Monitor Effective Resource Usage in Microsoft
Project Professional 2013 video
https://www.youtube.com/watch?v=jVPJShkdJxE
https://online.columbiasouthern.edu/bbcswebdav/xid-
117323003_1
https://www.youtube.com/watch?v=q5sPDJ66oL8
https://www.youtube.com/watch?v=q5sPDJ66oL8
https://online.columbiasouthern.edu/bbcswebdav/xid-
117323002_1
MGT 3302, Introduction to Project Management 5
UNIT x STUDY GUIDE
Title
Learning Activities (Nongraded)
Nongraded Learning Activities are provided to aid students in
their course of study. You do not have to submit
them. If you have questions, contact your instructor for further
guidance and information.
In each chapter, there are questions to “Reinforce Your
Learning” found in the left margin on some of the
pages. For example, in Chapter 6, questions are found on pp.
217, 218, 221, and 222. Answer the questions
to check your knowledge. The answers may be found starting on
page 487.
BOS 4201, Toxicology 1
Course Learning Outcomes for Unit VI
Upon completion of this unit, students should be able to:
7. Discuss the objectives of toxicity testing.
7.1 Explain the objectives of toxicity testing.
7.2 Assess the endpoints for toxicity testing.
Course/Unit
Learning Outcomes
Learning Activity
7.1 Unit Lesson, Unit Readings
7.2 Unit Lesson, Unit Readings
Reading Assignment
Chapter 21: Toxicity Testing
Unit Lesson
There are thousands of new chemicals introduced every year by
manufacturers, and the health risks from any
potential exposure need to be assessed for both the occupational
and environmental issues.
Toxicity Testing
Toxicity testing is performed to assess the health risks of
exposure. One purpose of the testing is to
determine a dose-effect, and the other is to determine the
toxicity relative to other known chemicals. There
are two common methods used for this; one uses laboratory
animals, and the other uses in vitro testing.
Other methods for testing include human data from exposures
and non-biological models.
The objectives of toxicity testing are to determine any adverse
effects. Exposure durations are an important
factor for toxicity testing. The categories of exposure duration
include acute, subacute, subchronic, and
chronic. The outcomes include the severity, if the effects are
reversible or irreversible, and if the effects are
immediate or delayed. The extent and complexity of the testing
are dependent on the type of chemical
hazard, how the chemical is being used, the projected level of
exposure, and the extent of the release into the
environment. The objective is to predict the human health
outcomes as a result of the route of exposure and
dose. A toxicity test must include the following components:
-developed protocol (Richards & Bourgeois, 2014, p.
368).
Endpoints to toxicity testing include the following indicators:
Toxicity testing on animals is used to make inferences on
human health. The data obtained from animal
testing is used to estimate human risk for both acute and chronic
exposures. In addition, the toxicity studies
UNIT VI STUDY GUIDE
Toxicity Testing
BOS 4201, Toxicology 2
UNIT x STUDY GUIDE
Title
using laboratory animals provide an understanding of how a
chemical may produce an adverse response in
humans. They also provide a range of exposure levels from no
effect to highly toxic, and they are a
justification for public health risk assessments (Richards &
Bourgeois, 2014). The most common animals
used are rats and mice as well as guinea pigs and rabbits. The
Society of Toxicology (2006) has a public
policy that states that research on animals is necessary and
reliable to predict toxic properties.
The Society of Toxicology (2006) adopted a public policy
statement concerning the use of animals for
toxicological studies, which has been summarized below.
sure
and enhance human and animal health
and protection of the environment.
animals is the most reliable means of
detecting important toxic properties of chemical substances and
for estimating risks to human and
environmental health.
replace the need for laboratory animals is
encouraged (Richards & Bourgeois, 2014, p. 371).
The endpoints of the toxicological tests must be quantifiable
and repeatable. It includes anything from
irritation to death. There are standardized tests to determine
such things as acute toxicity, dermal toxicity,
chronic toxicity, reproductive toxicity, and neurotoxicity
(Richards & Bourgeois, 2014).
Using death as an endpoint in toxicity testing is common, and
the results are expressed as LD50, the lethal
dose given in which 50% of the animals tested die. The LD50
does not provide any information on the chronic
effects. The route of exposure for the LD50 is usually oral. For
exposure where inhalation is the route of
exposure, the LC50 (lethal concentration) value is referenced,
and it also indicates that 50% of the test animals
died. Richards and Bourgeois (2014) stated, “It must be
recognized that the LD50 acute toxicity testing is a
poor indicator of human health effects because death is the least
desirable measure of toxicity” (p. 374).
Efficacy and the therapeutic index are two measures that
actually provide information on doses that will safely
utilize a chemical for treatment. Quantitatively measured, the
ED50 measures the efficacy, or the lowest
effective dose, that is evident in 50% of the population
(Richards & Bourgeois, 2014). The therapeutic index
(TI) indicates the safety of the drug. The higher the therapeutic
index, the safer the drug (Richards &
Bourgeois, 2014). A small therapeutic index indicates that there
is a small margin between the lethal/toxic
dose and effective dose. In other words, there is a higher risk of
overdosing versus treating a condition with
drugs that have a very small therapeutic index. However, drugs
with a high therapeutic index have a large
margin between the lethal/toxic dose and the effective dose,
and, therefore, they hold less of a risk in
overdosing with a dose that is effective for treatment of the
condition.
Human studies are another method of determining the toxicity
of a substance. Unfortunately, people have to
be exposed and experience the health effects before a health
effect is verified. There are a number of
sources for toxicity information from human studies, case
reports, clinical studies, and epidemiological
studies. Epidemiological studies are indicated when there are
questions regarding the relationship between
an exposure and disease. The results of an epidemiological
study show through numbers whether a
relationship exists and whether the results represent a relative
risk. For example, a smoker would be 20 times
more likely to develop lung cancer than a nonsmoker. Although
epidemiological studies offer obvious
advantages over laboratory studies, there are some notable
disadvantages, which are listed below.
antify exposures.
evaluation.
factors to question accuracy of results.
publish results (Richards & Bourgeois,
2014, p. 384).
BOS 4201, Toxicology 3
UNIT x STUDY GUIDE
Title
Any new chemical being introduced needs to be tested for
potential toxicity to human health and to the
environment. Both the acute and chronic effects must be known
to protect the health of those exposed. The
LD50 and the LC50 are important concepts in assessing the
endpoints of toxicity. Animals are used in the
testing of chemical toxicity, and there should be more methods
introduced to reduce or eliminate the distress
caused by the tests.
Alternatives to animal testing were proposed to overcome some
of the drawbacks associated with animal
experiments and to avoid the unethical procedures. The 3 Rs
strategy is being applied, which stands for
reduction, refinement, and replacement of laboratory use of
animals. Alternatives to animal testing, such as
tissue and cell cultures and computer modeling, offer limited
data in some cases but may be utilized as a
replacement for some types of animal testing. Alternative
methods are growing in popularity. Computer
modeling can provide information on alternatives. Researchers
are encouraged to replace the animal with
another test, reduce the total number of animals used, and refine
the study in order to reduce the distress of
laboratory animals (Richards & Bourgeois, 2014). The computer
models can help predict the toxicity from the
parent compound and the metabolites; this is especially
important for any substances that have not been
tested yet.
In vitro tests can be utilized to perform some endpoint toxicity
tests such as the ones listed below:
icity,
–
390).
References
Richards, I. S., & Bourgeois, M. M. (2014). Principles and
practice of toxicology in public health (2nd ed.).
Burlington, MA: Jones & Bartlett Learning.
Society of Toxicology. (2006). Animals in research: The
importance of animals in the science of toxicology.
Retrieved from
https://www.toxicology.org/pubs/docs/air/AIR_Final.pdf
Suggested Reading
Click here to access the Chapter 21 PowerPoint presentation.
Click here to access a PDF version of the
presentation.
https://online.columbiasouthern.edu/bbcswebdav/xid-
74389022_1
https://online.columbiasouthern.edu/bbcswebdav/xid-
74389009_1

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MGT 3302, Introduction to Project Management 1 Cou.docx

  • 1. MGT 3302, Introduction to Project Management 1 Course Learning Outcomes for Unit V Upon completion of this unit, students should be able to: 1. Describe the components of a basic project schedule. 1.1 Illustrate components of a project schedule, including a Gantt chart and network activity diagram. Course/Unit Learning Outcomes Learning Activity 1.1 Unit Lesson Chapter 6, pp. 214–232 Unit V Course Project Required Unit Resources Chapter 6: Resource Utilization, pp. 214–232
  • 2. Unit Lesson In this unit, we are discussing resource planning and resource utilization, which goes hand-in-hand with creating and managing a Gantt chart. In order to efficiently manage our resources and make full use of our Gantt chart, we need to have finalized our estimated durations and our predecessors. In this unit’s assignment, you will create a finalized list of activities with durations and predecessors, a network activity diagram based on that finalized list, and a Gantt chart. As a reminder, for our fair project, the predecessors and durations are shown below. Activity # Description Predecessors Estimated Duration (days) A Determine some potential dates for the fair. None 5 B Research potential available locations for a tent and space for 300 employees. A 3 C Discuss potential locations and cost. B 2 D Decide on a location. C 1 E Reserve the location. D 4 F Research companies that have fun day activities, such as dunking booths.
  • 3. A 1 G Discuss potential activities and cost. F 1 H Reserve the activities. G 2 I Gather a list of all other items needed (e.g., tables, chairs, garbage cans). E, N, H 7 J Research potential companies that will provide food, including lunch and fun fair food. A 1 K Discuss food options and cost. J 2 L Determine a potential menu. K 1 M Determine a company to hire. L 1 N Order food. M 1 O Communicate fun day to all employees. I 1 UNIT V STUDY GUIDE Resource Utilization
  • 4. MGT 3302, Introduction to Project Management 2 UNIT x STUDY GUIDE Title Our simplified activity network sequence, based on those predecessors, looks like the graphic below. But, what if we had other constraints to consider? What if there were only two people in our organization that could perform activities B, F, and J? This would mean that we have additional constraints on our resources that we must plan for and manage. Resource Planning In resource planning, there are many approaches to establishing a sequence for your activities. For example, a technically constrained activity sequence is a sequence of activities that takes technical constraints into consideration. For example, you cannot design a new software application until you have the requirements. You cannot write the code until you have the technical specs from the designer. So, one activity needs to be complete before another activity begins. This is the general basis of the current activity network sequencing for our fair project. There is also a resource-constrained activity sequence. This means that the sequence of activities must take resource constraints into consideration. As a reminder,
  • 5. resources for the purposes of activity networks generally refers to people who perform tasks. For example, let’s assume that you have three activities that can be performed concurrently or all at the same time. This is great and certainly a timesaver, except for the possibility that you only have two people who can perform those tasks. What do you do then? The project manager (PM) can only schedule two people at one time, so the activity sequence is constrained, and the third activity will have to occur after the first or second activity is complete. If this is the case, our activity network might change to accommodate the fact that of the three starting activities (i.e., B, F, and J), only two can occur at the same time. Then, our new activity network sequence might look something like the one shown below. MGT 3302, Introduction to Project Management 3 UNIT x STUDY GUIDE Title Did you notice how we changed two of the three paths? Would this change affect our critical path or expected end date for this project? Let’s calculate and see.
  • 6. To calculate the critical path, see the calculations below. = 1+5+3+2+1+2+1 = 15 days 15 days 1+7+1+2+1+1+2+1 = 16 days No, in this case, the critical path, which is path three, was not changed. Had we chosen to rearrange our paths differently though, we may have affected our critical path and our estimated end date. Resource Leveling As already mentioned, the PM has to enter all of the pertinent information into a Gantt chart. Once the PM has done that, then adjustments may be made throughout the life cycle of a project. But, how do we know how the changes affect the end date of our project? The main tool for understanding the end date of the project is resource leveling. If the PM makes a change to a predecessor, for example, then the PM can re- level the resources and see how the change affects the end date.
  • 7. As a reminder, below is a random example of a Gantt chart. As you can see from this random Gantt chart example, the resources have been leveled, and the project estimated end date is February 24. The blue lines show us whether activities are running concurrently or sequentially. They also show us what we need to complete before the next activity can start. If we had to make a change to the duration, a change to the resource who is performing a task, delete or add a task, or change the predecessors, then once we clicked to “Level Resources,” we would see a change in the blue lines. We may also potentially see a change to the estimated end date. As Gido, Clements, and Baker (2018) note, resource leveling also involves manipulating the start and finish dates so that the PM can balance the demand for resources. For example, in our fair project, we say that Activity J will take 7 days. Suppose the PM consults with the resource, who, after 3.5 days, tells us he or she is 75% done. At 3.5 days, the resource should only be 50% done. But, this is a positive thing, right? We are ahead of schedule! The PM will enter information into the Gantt chart indicating that the resource is 75% done. The PM then clicks to level resources, and we might see that our new project estimated end date is 2 days earlier. We use the term might because other constraints may be involved to prevent our project from completing 2 days earlier. As a matter of fact, we might have just added some slack time, and this change of 2 days does not affect our critical path at all. Conversely, if the
  • 8. resource should be 100% complete but is only 75% complete, then it is obviously taking the resource more MGT 3302, Introduction to Project Management 4 UNIT x STUDY GUIDE Title time to do the work than was originally estimated. This may mean that the project will push out a couple of days longer than expected. Similarly, what if a resource approaches the PM and indicates that his or her original estimate of the duration of his or her activity was not correct? Then, the PM would need to adjust that duration and re-level the resources. In projects, the term schedule slippage refers to missing a project deadline. In larger projects, especially high- profile projects like those you might find in the government, schedule slippage could mean there are fees or penalties assessed to the project organization. Also, we should aim to use our resources and budget as efficiently as possible. So, if we do not accurately estimate our durations, then we might have to hire in consultants to help, which is a costly endeavor. What are some of the things that a PM can do if he or she
  • 9. realizes that re-leveling resources causes the end date to be moved out too far? As mentioned previously, we can hire some contractors or authorize some overtime for our resources. But, you can only expect a resource to work so much before he or she gets tired and quality is diminished. We can hire a new person, but there will likely be a learning curve, and the cost of hiring someone new is always high. If it is a technical resource, we can send someone for training, but again, that would take time and cost money. Is the cost or benefit higher than the cost of the delayed project? We can also reevaluate our predecessors and look for activities that can occur concurrently rather than sequentially. Final note: One important tool that a PM can use is a resource requirements plan (RRP). An RRP is simply a plan for the expected utilization of resources. The PM will take all constraints into consideration to create a baseline schedule. These constraints could include items like a limit to the total hours that a resource can devote to the project or limits regarding when a resource needs to complete the project. For example, one resource may need to finish his or her activities in the first half of the project. The RRP is simply a tool or plan to help the PM keep up with the resource constraints for a project. Reference Gido, J., Clements, J. P., & Baker, R. (2018). Successful project management (7th ed.). Boston, MA: Cengage Learning.
  • 10. Suggested Unit Resources In order to access the following resources, click the links below. The following video provides an example of using resource capacity in Microsoft Project. Howard, B. (2018, February 6). Resource capacity vs work in MS Project [Video file]. Retrieved from https://www.youtube.com/watch?v=jVPJShkdJxE Transcript for Resource Capacity vs Work in MS Project video The video below discusses how to manage resource utilization. Springhouse Education & Consulting. (2014, June 24). Monitor effective resource usage in Microsoft Project Professional 2013 [Video file]. Retrieved from https://www.youtube.com/watch?v=q5sPDJ66oL8 Transcript for Monitor Effective Resource Usage in Microsoft Project Professional 2013 video https://www.youtube.com/watch?v=jVPJShkdJxE https://online.columbiasouthern.edu/bbcswebdav/xid- 117323003_1 https://www.youtube.com/watch?v=q5sPDJ66oL8 https://www.youtube.com/watch?v=q5sPDJ66oL8
  • 11. https://online.columbiasouthern.edu/bbcswebdav/xid- 117323002_1 MGT 3302, Introduction to Project Management 5 UNIT x STUDY GUIDE Title Learning Activities (Nongraded) Nongraded Learning Activities are provided to aid students in their course of study. You do not have to submit them. If you have questions, contact your instructor for further guidance and information. In each chapter, there are questions to “Reinforce Your Learning” found in the left margin on some of the pages. For example, in Chapter 6, questions are found on pp. 217, 218, 221, and 222. Answer the questions to check your knowledge. The answers may be found starting on page 487. BOS 4201, Toxicology 1
  • 12. Course Learning Outcomes for Unit VI Upon completion of this unit, students should be able to: 7. Discuss the objectives of toxicity testing. 7.1 Explain the objectives of toxicity testing. 7.2 Assess the endpoints for toxicity testing. Course/Unit Learning Outcomes Learning Activity 7.1 Unit Lesson, Unit Readings 7.2 Unit Lesson, Unit Readings Reading Assignment Chapter 21: Toxicity Testing Unit Lesson There are thousands of new chemicals introduced every year by manufacturers, and the health risks from any potential exposure need to be assessed for both the occupational and environmental issues. Toxicity Testing Toxicity testing is performed to assess the health risks of
  • 13. exposure. One purpose of the testing is to determine a dose-effect, and the other is to determine the toxicity relative to other known chemicals. There are two common methods used for this; one uses laboratory animals, and the other uses in vitro testing. Other methods for testing include human data from exposures and non-biological models. The objectives of toxicity testing are to determine any adverse effects. Exposure durations are an important factor for toxicity testing. The categories of exposure duration include acute, subacute, subchronic, and chronic. The outcomes include the severity, if the effects are reversible or irreversible, and if the effects are immediate or delayed. The extent and complexity of the testing are dependent on the type of chemical hazard, how the chemical is being used, the projected level of exposure, and the extent of the release into the environment. The objective is to predict the human health outcomes as a result of the route of exposure and dose. A toxicity test must include the following components: -developed protocol (Richards & Bourgeois, 2014, p. 368). Endpoints to toxicity testing include the following indicators:
  • 14. Toxicity testing on animals is used to make inferences on human health. The data obtained from animal testing is used to estimate human risk for both acute and chronic exposures. In addition, the toxicity studies UNIT VI STUDY GUIDE Toxicity Testing BOS 4201, Toxicology 2 UNIT x STUDY GUIDE Title using laboratory animals provide an understanding of how a chemical may produce an adverse response in humans. They also provide a range of exposure levels from no effect to highly toxic, and they are a justification for public health risk assessments (Richards & Bourgeois, 2014). The most common animals used are rats and mice as well as guinea pigs and rabbits. The Society of Toxicology (2006) has a public policy that states that research on animals is necessary and
  • 15. reliable to predict toxic properties. The Society of Toxicology (2006) adopted a public policy statement concerning the use of animals for toxicological studies, which has been summarized below. sure and enhance human and animal health and protection of the environment. animals is the most reliable means of detecting important toxic properties of chemical substances and for estimating risks to human and environmental health. replace the need for laboratory animals is encouraged (Richards & Bourgeois, 2014, p. 371). The endpoints of the toxicological tests must be quantifiable and repeatable. It includes anything from irritation to death. There are standardized tests to determine such things as acute toxicity, dermal toxicity, chronic toxicity, reproductive toxicity, and neurotoxicity (Richards & Bourgeois, 2014). Using death as an endpoint in toxicity testing is common, and the results are expressed as LD50, the lethal dose given in which 50% of the animals tested die. The LD50 does not provide any information on the chronic effects. The route of exposure for the LD50 is usually oral. For
  • 16. exposure where inhalation is the route of exposure, the LC50 (lethal concentration) value is referenced, and it also indicates that 50% of the test animals died. Richards and Bourgeois (2014) stated, “It must be recognized that the LD50 acute toxicity testing is a poor indicator of human health effects because death is the least desirable measure of toxicity” (p. 374). Efficacy and the therapeutic index are two measures that actually provide information on doses that will safely utilize a chemical for treatment. Quantitatively measured, the ED50 measures the efficacy, or the lowest effective dose, that is evident in 50% of the population (Richards & Bourgeois, 2014). The therapeutic index (TI) indicates the safety of the drug. The higher the therapeutic index, the safer the drug (Richards & Bourgeois, 2014). A small therapeutic index indicates that there is a small margin between the lethal/toxic dose and effective dose. In other words, there is a higher risk of overdosing versus treating a condition with drugs that have a very small therapeutic index. However, drugs with a high therapeutic index have a large margin between the lethal/toxic dose and the effective dose, and, therefore, they hold less of a risk in overdosing with a dose that is effective for treatment of the condition. Human studies are another method of determining the toxicity of a substance. Unfortunately, people have to be exposed and experience the health effects before a health effect is verified. There are a number of sources for toxicity information from human studies, case reports, clinical studies, and epidemiological studies. Epidemiological studies are indicated when there are questions regarding the relationship between an exposure and disease. The results of an epidemiological
  • 17. study show through numbers whether a relationship exists and whether the results represent a relative risk. For example, a smoker would be 20 times more likely to develop lung cancer than a nonsmoker. Although epidemiological studies offer obvious advantages over laboratory studies, there are some notable disadvantages, which are listed below. antify exposures. evaluation. factors to question accuracy of results. publish results (Richards & Bourgeois, 2014, p. 384). BOS 4201, Toxicology 3 UNIT x STUDY GUIDE Title
  • 18. Any new chemical being introduced needs to be tested for potential toxicity to human health and to the environment. Both the acute and chronic effects must be known to protect the health of those exposed. The LD50 and the LC50 are important concepts in assessing the endpoints of toxicity. Animals are used in the testing of chemical toxicity, and there should be more methods introduced to reduce or eliminate the distress caused by the tests. Alternatives to animal testing were proposed to overcome some of the drawbacks associated with animal experiments and to avoid the unethical procedures. The 3 Rs strategy is being applied, which stands for reduction, refinement, and replacement of laboratory use of animals. Alternatives to animal testing, such as tissue and cell cultures and computer modeling, offer limited data in some cases but may be utilized as a replacement for some types of animal testing. Alternative methods are growing in popularity. Computer modeling can provide information on alternatives. Researchers are encouraged to replace the animal with another test, reduce the total number of animals used, and refine the study in order to reduce the distress of laboratory animals (Richards & Bourgeois, 2014). The computer models can help predict the toxicity from the parent compound and the metabolites; this is especially important for any substances that have not been tested yet. In vitro tests can be utilized to perform some endpoint toxicity tests such as the ones listed below:
  • 19. icity, – 390). References Richards, I. S., & Bourgeois, M. M. (2014). Principles and practice of toxicology in public health (2nd ed.). Burlington, MA: Jones & Bartlett Learning. Society of Toxicology. (2006). Animals in research: The importance of animals in the science of toxicology. Retrieved from https://www.toxicology.org/pubs/docs/air/AIR_Final.pdf
  • 20. Suggested Reading Click here to access the Chapter 21 PowerPoint presentation. Click here to access a PDF version of the presentation. https://online.columbiasouthern.edu/bbcswebdav/xid- 74389022_1 https://online.columbiasouthern.edu/bbcswebdav/xid- 74389009_1