Pharmacological Studies: Understanding Chemical Risk Assessment and Toxicity Testing

Running head: PHARMACOLOGICAL STUDIES
FOOD ADDITIVE RELATED QUESTION ANSWERS
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1PHARMACOLOGICAL STUDIES
Answer 1
Chemical risk assessment is an important process that is used to protect the society and
the surroundings from unnecessary hazardous materials it utilizes several regulatory actions such
as hazard identification, dose response assessment and assessment related to exposure so that the
risk characterization can be carried out and regulatory action against that can be taken (Crevel et
al. 2014). The assessment of the hazardous material can be carried out using several core
biological and toxicological in vitro and in-vivo studies. These toxicity studies are general
systemic toxicity, acute toxicity, genotoxicity, carcinogenicity and neurotoxicology. Whereas,
the biological tests are determined to understand the level of arsenic, cadmium, led and mercury
and several other heavy metals that affect the health of humans (Weir et al. 2012). These in vitro
and in vivo testing are used to understand the mechanism of toxicity and to characterize the
metabolism of the chemicals.
The general systemic toxicity is determined to understand the target organs for the toxic
material. This is generally dependent on the principles of repeated dose protocol. For the testing,
dose selection is an important aspect as the higher dose should not lead to death and the lower
dose should not determine any adverse effect (Covello and Merkhober 2013). This testing is
conducted over a duration as repeated dosing are important. For the tests, the subjects are divided
into three sections of sub-acute, sub chronic and chronic and they are separated by the dose of
toxic material ingested to determine the effectiveness (Bolon et al. 2012). The observation of the
toxicity is determined by observing the mortality, body weight and feed intake of the test animal,
hematological and ophthalmological tests, urinalyses, necropsy and reversibility to previous
condition.

2PHARMACOLOGICAL STUDIES
Acute toxicity is the response of an organism which has been exposed, ingested or
injected with a chemical toxicant as a single or multiple exposure dose. The time span for acute
toxicity is shorter and within that shorter span, the effect of the toxic substance on the organism
is determined (Wood et al. 2012). This testing is not generally carried out as human system
requires much longer and higher dose and time span to feel or observe the adverse effect of
chemical substance on human body, however if the food material is contained with high
microbial or heavy metal related load, acute effects are observed. Hence, it is involved in food
product regulatory testing (Hermanns‐Clausen et al. 2013). Therefore, it is necessary to develop
ARfD related study in food and drinking water and appropriate observation and evaluation
should be carried out related to single or multiple dose studies so that effect of these chemical
toxins can be determined effectively (Wood et al. 2012).
Genotoxicity and neurotoxicity are two important toxicological and chemical testing that
are carried out to determine the adverse effects of toxic substances. Where Genotoxicity
determines the adverse effect of the toxic substance of inherited genetic material, the
neurotoxicity determines the effectiveness of toxic materials that exerts adverse effect on the
nervous system of the humans (Pieper et al., 2014). The assay that are conducted to understand
the degree of genotoxicity are DNA repair related toxicity, gene mutation related toxicity and
chromosomal aberration. In these clinical studies both in vitro and in vivo approach is carried out
using which somatic cell assay, germ line cell assay, specific locus test is carried out in mice (in
vivo), and Mouse lymphoma L5178Y, Mouse lymphoma P388F (Wang 2013), Human
lymphocytes and several other testing are carried out in vitro. The biological tests, which are
carried out to understand the effectiveness of heavy metals on the health of the consumers. The
inorganic and organic arsenic, cadmium, lead and mercury related testing are carried out which

3PHARMACOLOGICAL STUDIES
are found not only in food, water and beverages but also in cosmetics, environmental pollutions,
dental amalgam diet, vaccine related diet and so on. There are several analytical methods, using
which such levels in these products are determined. These methods are primarily determine and
quantify the effect of these heavy metals on the health of the consumers (Pieper et al. 2014).
In the above section, the required toxicological and biological tests have been mentioned,
which is required to conduct prior to dispatch in the market and national and international
agencies such as European chemical Agency, European Food safety authority and medicine
agency should check the compliance of the product with the guidelines so that consumer safety
can be determined. However, there are situations, when it is not required to carry out a full set of
toxicological studies (Covello and Merkhober 2013). For example, if the genotoxicity testing has
been carried out for the additive or medicinal product and the result shows the harmful effect of
the product, then it is not required to carry out acute toxicity or neurotoxicity. Therefore, in such
situation where utilization of one toxicological test can determine the adversity of any substance,
it is not required to carry out another steps (Pieper et al. 2014).
Answer 2
According to the World Health Organization (2018), The Acceptable Daily Intake or ADI
is the estimated amount of chemical present in food, drinking water or beverages, that can be
ingested to human body and that do not exert any adverse effect on the human body. This
chemical is expressed in food or drink on a body weight basis and is evaluated as milligram of
chemical on kilogram of body weight. Products which are generally put under scrutiny for
determination of toxic substances and their ADI are food additives, drugs, usage of pesticides
and residues while preparation of that food product (Huang et al. 2014). Depending on this