Chemical hazards

SES' R. C. PATEL INSTITUTE OF PHARMACY, SHIRPUR 1
Guided By :
Ms. Preeti S. Bobade
Assistant Professor
QA Department
Control Measures For Chemical Hazards
Department of Pharmaceutical Quality Assurance,
R. C. Patel Institute of Pharmacy, Shirpur.
Date of Seminar : 24/02/2024
Presented By :
Samir Nurejamil Patel
F.Y. M. Pharm (QA)
Roll no. : 108

Introduction
Classification & Pictograms
Regulations of Chemical hazards
MSDS Guide
Control measures
Hazard safety management
Case study
References
1.
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8.
Contents

Introduction
 A chemical hazard is a type of occupational hazard caused by exposure to chemicals in
the workplace. Exposure to these chemicals in the workplace can cause acute or long-term
detrimental health effects to the human body.
Occupational
Safety & Health
Administration
32
Millions
Industrial workers are
potentially exposed to
one or more chemical
hazards.
There are
approximately
6,50,000 existing
chemical products,
and hundreds of new
ones being utilized
annually in the
chemical industries.
&
 In pharmaceutical industry major chemical hazards are low in frequency but are
significant in terms of potential to loss of lives, injuries, environmental impact &
socioeconomic implications.
 A hazard is a source or a situation produced by physical, chemical &
biological material that may cause injury or death to personnel or loss of product
or property or does damage to the environment or a combination of these.

1. Organic synthesis hazards
 The active agents of organic compounds are exceptionally
able to produce highly poisonous effects.
 The intermediate compounds & finished products in most
organic synthesis are generally imposes hazardous effects.
2. Organic solvents hazards
 The flammability and explosiveness of a solvent are
decisive determinants of the risk associated with its use.
 Inhalational exposure of volatile organic solvents and an
easy absorption through the skin are the two most
important ways of exposure to the workplace.
 Example:
1) Acetonitrile
2) Toluene
3) Xylene
 Example:
1) Dimethyl sulfoxide (DMSO)
2) Benzene
3) Sodium azide
Inhalation Skin contact Eye contact Ingestion
Routes of exposure to
chemicals
Introduction cont.

Introduction cont.
Health effects Exposure Example
Acute Appears immediately or within
short time following exposure
(minutes or hours) ; death possible
from hazardous substances
Sudden , short-term &
high concentration of
exposure
Headache, collapse
or death from high
levels of carbon
monoxide
Chronic Usually develops slowly, as long as
15-20 years or more
Continued or repeated
for a prolonged period,
usually years
Lung cancer from
exposure to
asbestos
Some chemicals can
have both acute &
chronic effects
EX. Carbon monoxide
 The introduction of sulphuric acid group in benzene ring is called sulphonation, in which benzene ring is heated with fuming
sulphuric acid.
3. Sulphonating hazards
 The sulphonation hazard is occurred due to the corrosive nature of six-membered ring structure and fumes of sulphur trioxide.
These sulphunating chemicals can have mutagenic, teratogenic & carcinogenic effects
 Example : A) Ethyl methanesulphonate B) Benzenesulphonic acid

Classification
 Hazard classification is the process of evaluating the full range of available scientific evidence to determine if a
chemical is hazardous, as well as to identify the level of severity of the hazardous effect.
 "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)", addresses classification of
chemicals by types of hazard and proposes harmonized hazard communication elements, including labels and safety
data sheets.
Determining the degree of the hazard, where appropriate, by comparing the data
with the criteria for health and physical hazards
The hazard classification process
Identifying the chemical
Identifying the relevant data regarding the hazards of a chemical
Reviewing the relevant data to ascertain the hazards associated with the chemical
Determining whether the chemical will be classified as hazardous according to the
definition of hazardous chemical in the standard

Classification cont. By Workplace hazardous materials information (WHMI) :
Class -A
Class -B
Class -C
Class -D
 Liquefied gas
 Compressed gas
 Dissolved gas
 Flammable gases
 Combustible liquids
 Flammable aerosols
 Oxidizer: Chlorates, nitric oxide,
peroxides
 Oxidize metal powder
 Organic peroxide: Tetrahydrofuran,
diethyl ether
 Poisonous and infectious materials
 Cyanides & Aasbestos
 Tea salts
Class -E
 Corrosive materials
 Inorganic acids and bases
 hydrogen fluoride
Class -F
 Dangerous reactive material
 Ethylene dioxide & Organic azides
 White phosphorous, Diethyl aluminium
chloride & Na, Li, Ca
Highly flammable: Flashpoint 23°C.
Combustible: Flammability point 61–150°C
Flammable : Flammability point 23–61°C.

Hazards pictograms
 The GHS (Global Harmonized System) part of OSHA's Hazard Communication Standard (HCS) it consists
of symbols or pictograms, providing recognition of the hazards associated with certain substances.
Health Hazard Flammable materials Narcotic Chemical Gas Cylinder
Poisonous Substance Corrosion Exploding Bomb Oxidizers Environmental Hazard
Biohazard Radioactive
Irritant Chemical

Regulations
India
Manufacture, Storage And Import Of Hazardous Chemical (Amendment) Rules, 1989. This
amendment regulates the manufacture, storage and import of hazardous chemicals in India. The
transport of hazardous chemicals must meet the provisions of the Motor Vehicles Act, 1988.
Ozone Depleting Substance (R&C) Rules (2000), this regulation strictly controls the production,
import and use of ozone depleting substances (ODS) in India & most of ODS are banned in India.
1
Hazardous Waste Management Rules, came into effect in the year 1989 and have been amended
later in the years 2000, 2003. This amendment ensures safe handling, generation, processing,
treatment, package, storage, transportation, use reprocessing, collection, conversion, and offering for
sale, destruction and disposal of Hazardous Waste.
2
3

Regulations
USA
OSHA regulates exposure of chemicals by “Worker education and training (Hazard Communication
Standard) & Hazard safety management under 29 CFR part 1910 & 1200.
NIOSH is the United States federal agency under “CDCP” responsible for conducting research on
hazards drugs and prevention of work-related injury and illness.
The U.S. Chemical Safety Board (CSB) is an independent, nonregulatory federal agency that
investigates the root causes of major chemical hazard incidents.
1
Under the Toxic Substances Control Act (TSCA), as amended in Chemical Safety for the 21st
Century Act, US Environment Protect Agency (EPA) evaluates potential risks from new and
existing chemicals and acts to address any unreasonable risks chemicals may have on human health
and the environment.
2
3

MSDS Guide
 A Material Safety Data Sheet (MSDS), is a detailed informational document prepared by the manufacturer or
importer of a hazardous chemical. Which contains detailed chemical and physical information, hazards,
handling and storage procedures along with emergency protocols.
Purpose
1) Identifying Hazards
2) Protecting Workers
3) Emergency Preparation
4) Environmental Safety
Benefits
Components
1) Worker Safety
2) Compliance
3) Efficient Emergency
Response
4) Knowledge and
Training
1) Hazard Identification
2) Information on Ingredients
3) First Aid Measures
4) Fire-Fighting Measures
5) Accidental Release
Measures
6) Handling and Storage
7) Exposure Controls &
Personal Protection
8) Toxicological Information
9) Transport & Disposal
Considerations
10) Regulatory Information

Hierarchy of control
Control measures
Elimination
Substitution
Engineering
Control
Administrative
Control
PPE
Most
Effective
Least
Effective
Isolate people from hazard &
implement General dilution ventilation
Adjust work schedules so that workers are
not overexposed to a hazardous chemical
Protect the worker with Personal Protective
Equipment & respiratory protectives
Replace the hazards substance
with substitutes
Physically remove all type
of hazardous material

Control measures
 Permissible Exposure Limits : PELs can provide information on acceptable levels of chemicals in workplace.
 Recommended Exposure Limits : By National Institute for Occupational Safety and Health (NIOSH) RELs are
intended to limit exposure to hazardous substances in workplace air to protect worker health.
Threshold Limit Values (TLVs®) :
 TLVs are the amounts of chemicals in the air that almost all healthy adult
workers are predicted to be able to tolerate without adverse effects.
 These are guidance values for assessing biological monitoring results
concentrations of chemicals in biological media (e.g., blood, urine).
 BEIs represent the levels of determinants that are most likely to be
observed in specimens collected from healthy workers who have been
exposed to chemicals in the same extent as workers with inhalation
exposure at the TLV®.
Biological Exposure Indices (BEIs®) :
 Types : 1) TLV-TWA (TLV - Time-Weighted Average)
2) TLV-STEL (TLV - Short Term Exposure Limits)
3) TLV-C (TLV - Celling limits)

Safety management
 To help ensure safe and healthful workplaces, OSHA has issued the Process Safety Management of Highly
Hazardous Chemicals standard under (29 CFR 1910 &1200), which contains requirements for the management
of hazards associated with processes using highly hazardous chemicals.
Safety
management
of over
exposure
1. Removal From Exposure :
2. Decontamination :
3. Resuscitation :
4. Symptomatic treatment :
• Resuscitation refer as restoring the life
of someone who is apparently collapsed
or shocked.
• If the victim is apneic, resuscitation
should start as soon as it is removed
from the contaminated area.
• It protects workers from
hazardous substances
• Protects all site personnel by
minimizing the transfer of
harmful materials into clean area
• Immediate removal of the
victims should be there from
contaminated area
• Respirators and rescue lines
are compulsory first aid
Symptomatic treatment, supportive
care, supportive therapy, or palliative
treatment is any medical therapy of a
disease that only aims to treat
symptoms only.

Safety management
I. Air-purifying respirators (APRs)
II. Atmosphere-supplying respirators (ASRs).
 Explanation of the hazardous communication
program, including information on labels, SDSs,
and how to obtain and use available hazard
information
 How to detect the presence or release of a
hazardous chemical (using monitoring devices,
observation, or smell)
 Hazards and potential health effects of chemicals
 Protective measures such as engineering controls,
work practices, and the use of PPE
What training is needed to protect workers?
Chemical Safety Training
 Training is required for employees who are exposed
to hazardous chemicals in their work area
1) At the time of initial assignment
2) Whenever new hazard is introduced into their
workplace
 Respiratory Protection :

Case study A Laboratory Accident of Acryloyl Chloride, Its
Consequences, Treatment, and Safety Measures
 Acryloyl chloride is a pale yellow, highly toxic, volatile
liquid that is used in the synthesis of irreversible inhibitors
and biomaterials.
 The most common reaction that is involved in the synthesis
of irreversible EGFR TKI is the addition of the acryloyl
group to the amino group of the intermediate using acryloyl
chloride.

Case study
Effects of acryloyl chloride after accidental inhalation

Reference
 Research Review Articles References :
1) Bhowmik D, Durai Vel S, Rajalakshmi AN, Sampath Kumar K. Recent Trends in Hazards in the Pharmaceutical Industry
and Safety Precaution. Elixir Pharmacy. 2014 Apr 20;69:23688-91.
2) Agarwal P, Goyal A, Vaishnav R. Chemical hazards in pharmaceutical industry: an overview. Asian J. Pharm. Clin. Res.
2018;11:27-35.
3) Bhusnure OG, Dongare RB, Gholve SB, Giram PS. Chemical hazards and safety management in pharmaceutical industry.
Journal of Pharmacy Research. 2018 Apr;12(3):357-69.
4) Pathan A, Ahmad I, Girase R, Jagatap V, Patel H. A Laboratory Accident of Acryloyl Chloride, Its Consequences,
Treatment, and Safety Measures: An Arduous Lesson to All Researchers. ACS Chemical Health & Safety. 2022 Aug
23;29(5):405-20.
 Website References :
1) Permissible Exposure Limits - Annotated Tables | Occupational Safety and Health Administration (osha.gov)
2) What is a hazard and what is risk? (dmp.wa.gov.au)
3) Chemical Hazards and Toxic Substances - Overview | Occupational Safety and Health Administration (osha.gov)
4) Know Your Hazard Symbols (Pictograms) | Office of Environmental Health and Safety (princeton.edu)
5) Occupational Risk Assessment | NIOSH | CDC

Reference
5) Overview of Chemical Regulations in India and Latest Developments (chemsafetypro.com)
6) Types of Respiratory Protection | NPPTL | NIOSH | CDC
7) Chemistry: Health hazard symbols for chemicals ~ Lifeformation: Information for your life
8) https://www.hseblog.com/material-safety-data-sheet-msds
9) https://www.epa.gov/chemicals-under-tsca.com
10) TLVs Explained | Office of Environmental Health and Safety | ECU
11) About the GHS | UNECE
12) CPCB | Central Pollution Control Board
13) About NIOSH | NIOSH | CDC

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