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DRAFT GUIDANCE FOR
HAZARD DETERMINATION
FOR COMPLIANCE WITH THE
OSHA HAZARD COMMUNICATION STANDARD
(29 CFR 1910.1200)
U.S. Department of Labor Occupational Safety and Health Administration
TABLE OF CONTENTS
OVERVIEW
INTRODUCTION
What is Hazard Determination?
Who Must Conduct Hazard Determinations?
What Resources are Needed to Conduct a Hazard Determination?
How Should This Guidance Document be Used?.
THE HAZARD DETERMINATION PROCESS
What is the HCS Definition of "Chemical"?
How Will I Know if My Chemical is "Hazardous"?
Is Hazard Determination the Same for Mixtures as for Individual Elements and Compounds?
What is Involved in the Conduct of a Hazard Determination?
SELECTION OF CHEMICALS
DATA COLLECTION
Physical and Chemical Properties
Health Effects
DATA ANALYSIS
Physical Hazards
Health Hazards
DATA DOCUMENTATION
Chemical Inventory
Description of Procedures Used in Hazard Determination
Specific Data Retrieved for Each Chemical. 40
APPENDICES
OVERVIEW
This document is designed to help manufacturers and importers of chemicals identify chemical hazards so that employees and downstream users can be informed about these hazards, as required by the Occupational Safety and Health Administration’s (OSHA) Hazard Communication Standard. This guidance may also be useful to employers who decide to conduct hazard determinations in order to assure the accuracy and completeness of information provided to them by suppliers. Hazard determination is the critically
important first stage in the process of establishing an effective hazard communication program.
The process of hazard determination consists of four basic steps. These are:
- Selection of chemicals to evaluate;
- Collection of data;
- Analysis of the collected data; and
- Documentation of the hazard determination process and the results obtained.
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The intent of this document is to provide guidance as to the processes involved and to identify considerations in the conduct of hazard determinations. Since much of the discussion is of a technical nature, a Glossary of Terms and Definitions is included as Appendix A.
This guidance document provides a description of the hazard determination process. This document does not itself alter or determine compliance responsibilities, which are set forth in the Hazard Communication Standard (29 CFR 1910.1200) and in the Occupational Safety and Health Act. Moreover, because interpretations and enforcement policy may change over time, the reader should consult current administrative interpretations and decisions by the Occupational Safety and Health Review
Commission and the courts for additional guidance on OSHA compliance requirements.
Material contained in this publication is in the public domain and may be reproduced, fully or partially, without permission. Source credit is requested but not required.
INTRODUCTION
OSHA’s Hazard Communication Standard (HCS) is designed to protect against chemical source illnesses and injuries by ensuring that employers and employees are provided with sufficient information to recognize chemical hazards and take appropriate protective measures. This information is provided through material safety data sheets (MSDSs), labels, and worker training. In order for MSDSs, labels, and training to be effective, the hazard information they convey must be complete and accurate.
Thus it is critically important to obtain comprehensive and correct information about the hazards associated with particular chemicals.
What is Hazard Determination?
Hazard determination is the process of evaluating available scientific evidence in order to determine if a chemical is hazardous. This evaluation identifies both physical hazards (e.g., flammability or reactivity) and health hazards (e.g., carcinogenicity or sensitization). The hazard determination provides the basis for the hazard information that is provided in MSDSs, labels, and worker training.
Hazard determination does not involve an estimation of risk. The difference between the terms hazard and risk has often been poorly understood. Hazard refers to an inherent property of a substance that is capable of causing an adverse effect. Risk, on the other hand, refers to the probability that an adverse effect will occur with specific exposure conditions. Thus a substance will present the same hazard in all situations due to its innate chemical or physical properties and its actions on cells and tissues. However, considerable differences may exist in the risk posed by a substance, depending on how the substance is contained or handled, personal protective measures used, and other conditions that result in or limit exposure. This document addresses only the hazard determination process, and will not discuss risk assessment.
Who Must Conduct Hazard Determinations?
Only chemical manufacturers and importers are required to perform hazard determinations on the chemicals they produce or import. Under the HCS, an employer that manufactures, processes, formulates, or repackages a hazardous chemical is considered a "chemical manufacturer." Distributors and employers may also choose to conduct hazard determinations if they are concerned about the adequacy of hazard information for the chemicals they use in their business or distribute to others.
Regardless of who performs the hazard determination, the procedures used must be described in writing and made available, upon request, to employees and their designated representatives, as well as OSHA and National Institute for Occupational Safety and Health (NIOSH) officials.
What Resources are Needed to Conduct a Hazard Determination?
Two primary resources are required for hazard determination. First is complete and accurate literature and data concerning the chemical in question. Second is the ability to properly understand and interpret the information retrieved in order to identify and document hazards. Manufacturers and importers of hazardous chemicals are responsible for ensuring that hazard information provided to their employees and downstream users is complete and accurate. To achieve this, the persons assigned to conduct
hazard determinations must have the ability to conduct complete and effective literature and data retrieval. They should also be able to interpret the literature and data in order to determine the nature and extent of physical and health hazards. A lack of qualified employees does not exempt a manufacturer or importer from compliance with the HCS.
How Should This Guidance Document be Used?
The hazard determination requirements of the HCS are performance oriented. That is, chemical manufacturers, importers, and employers evaluating chemicals are not required to follow any specific procedures for determining hazards, but they must be able to demonstrate that they have adequately ascertained the hazards of the chemicals produced or imported in accordance with the criteria set forth in the HCS.
This guidance document will not provide detailed methods that must be followed. However, a basic framework for hazard determination is provided, along with a description of a process that can be used to conform to the requirements of the HCS. The interpretation of information relating to the physical and health hazards associated with a chemical can be a highly technical undertaking, and is often conducted by experienced toxicologists and industrial hygienists. This document will
not replace the need for such professional expertise in certain situations. It is intended to serve only as useful guidance as to the basic considerations and operational aspects involved in the conduct of hazard determinations.
THE HAZARD DETERMINATION PROCESS
What is the HCS Definition of a "Chemical"?
The definition of chemical in the HCS is much broader than that which is commonly used. The HCS definition of chemical is "any element, chemical compound, or mixture of elements and/or compounds." Thus virtually any product is a "chemical." These various types of chemicals are as follows:
- Element - the simplest form of matter. There are currently 109 known elements in the periodic table. Examples of elements are aluminum, carbon, chlorine, hydrogen, mercury and oxygen.
- Chemical compound - a substance consisting of two or more elements combined or bonded together so that its constituent elements are always present in the same proportions.
- Mixture – any combination of two or more chemicals if the combination is not, in whole or in part, the result of a chemical reaction.
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Although virtually all materials are considered chemicals under this definition, the HCS identifies certain categories of chemicals that are not covered by the standard. These categories are: Any hazardous waste as defined by the Solid Waste Disposal Act when subject to regulations issued under that Act by the Environmental Protection Agency;
Any hazardous substance as defined by the Comprehensive Environmental Response, Compensation and Liability Act when the hazardous substance is the focus of remedial or removal action being conducted under that Act in accordance with Environmental Protection Agency regulations;
Tobacco or tobacco products;
Wood or wood products, including lumber which will not be processed, where the chemical manufacturer or importer can establish that the only hazard they pose to employees is the potential for flammability or combustibility (wood or wood products which have been treated with a hazardous chemical covered by this standard, and wood which may be subsequently sawed or cut, generating dust, are not exempted);
Articles, defined as a manufactured item other than a fluid or particle: (i) which is formed to a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical, and does not pose a physical hazard or health risk to employees.
Food or alcoholic beverages which are sold, used, or prepared in a retail establishment (such as a grocery store, restaurant, or drinking place), and foods intended for personal consumption by employees while in the workplace;
Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act, when it is in solid, final form for direct administration to the patient (e.g., tablets or pills); drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs); and drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies);
Cosmeticswhich are packaged for sale to consumers in a retail establishment, and cosmetics intended for personal consumption by employees while in the workplace;
Any consumer productor hazardous substance, as those terms are defined in the Consumer Product Safety Act and Federal Hazardous Substances Act, respectively, where the employer can show that it is used in the workplace for the purpose intended by the chemical manufacturer or importer of the product, and the use results in a duration and frequency of exposure which is not greater than the range of exposures that could reasonably be experienced by consumers
when used for the purpose intended;
Nuisance particulates where the chemical manufacturer or importer can establish that they do not pose any physical or health hazard covered under this section;
Ionizing and nonionizing radiation; and
Biological hazards.
How Will I Know if My Chemical is "Hazardous"?
Under the HCS, any chemical that is a physical hazard or a health hazard is considered a hazardous chemical. The HCS definitions for physical and health hazards are:
- Physical hazard means a chemical for which there is scientifically valid evidence that it is a combustible liquid, a compressed gas, explosive, flammable, an organic peroxide, an oxidizer, pyrophoric, unstable (reactive) or water-reactive.
- Health hazard means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act
on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. [ ]
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These different types of hazards identified in the HCS are presented in Table 1.
Table 1. HCS Listed Hazard Categories
Physical Hazards |
Health Hazards |
| Fire Hazards |
Systemic Effects |
| Combustible liquid |
Carcinogen |
| Flammable liquid |
Toxic agent |
| Flammable aerosol |
Highly toxic agent |
| Flammable gas |
Corrosive |
| Flammable solid |
Irritant |
| Oxidizer |
Sensitizer |
| Pyrophoric |
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Target Organ Effects |
| Explosion Hazards |
Hepatotoxin |
| Compressed gas |
Nephrotoxin |
| Explosive |
Neurotoxin |
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Blood/hematopoietic toxin |
| Reactive Hazards |
Respiratory toxin |
| Organic peroxide |
Reproductive toxin |
| Unstable (reactive) |
Cutaneous hazard |
| Water-reactive |
Eye hazard |
For a hazard determination to be complete, one must consider all possible hazards, and document any hazards that are identified. While the hazards listed in the HCS represent the majority of potential workplace hazards, the list is not all-inclusive, especially for health hazards. Table 2 is a list of important health hazards that should be evaluated in addition to those specifically listed by HCS. In conducting the hazard determination, one should be awarecognizant of all
types of physical and health hazards.
| Table 2. Other Important Health Hazards |
| Cardiovascular toxicity |
Gastrointestinal toxicity |
| Immunotoxicity |
Skeletal/muscular effects |
| Connective tissue effects |
Endocrine system toxicity Sensory organ toxicity (sight, hearing, taste) |
| Sensory organ toxicity (sight, hearing, taste) Endocrine system toxicity |
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Certain chemicals are specifically designated as hazardous by the HCS. The HCS listing of hazardous chemicals has been referred to as the "floor" from which other hazardous chemicals should be added. The HCS base list of hazardous chemicals are provided in the following references:
- OSHA Toxic and Hazardous Substances, 29 CFR part 1910, Subpart Z (see Appendix C);
- Threshold Limit Values for Chemical Substances and Physical Agents (American Conference of Governmental Industrial Hygienists, latest edition);
or
Carcinogens or potential carcinogens according to one or more of the following sources:
- 29 CFR part 1910, Subpart Z, Toxic and Hazardous Substances (OSHA) (see Appendix D);
- National Toxicology Program Annual Report on Carcinogens, latest edition (see Appendix E);
- International Agency for Research on Cancer Monographs, latest editions (see Appendix F).
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The definition for hazardous chemical in the standard is thus very broad, and it is not likely that many chemicals will be considered as non-hazardous if they have been adequately tested. However, the standard does not require the testing of chemicals - only the collection and analysis of currently available data. Testing should be considered if hazardous properties are suspected.
Is Hazard Determination the Same for Mixtures as for Individual Elements and Compounds?
Generally speaking, the chemical and physical properties and hazards of pure elements and chemical compounds are precise and constant. For example, benzene has explicit boiling and flashpoints of 1760 F and 120 F (at sea level), respectively. In contrast, the properties of the complex mixture, Stoddard Solvent, can vary considerably depending on the manufacturer and lot received, with ranges for boiling and flash points of 309-3960 F and 102-1100 F, respectively.
The process for evaluating mixtures may require additional steps in addition to those indicated for single chemical agents. The HCS has designated specific requirements for mixtures. These requirements depend upon the availability of test data as indicated below:
- If a mixture has been tested as a whole, the results should be used to determine whether the mixture is hazardous.
- If a mixture has not been tested as a whole for health hazards, the mixture shall be assumed to present the name hazards as components of 1.0 percent (1%) or greater of the mixture. An exception pertains to carcinogens. In this case, the mixture shall be assumed to present a carcinogenic hazard if it contains a carcinogenic component of 0.1 percent (0.1%) or greater.
- If a mixture has not been tested as a whole to determine whether the mixture is a physical hazard, the chemical manufacturer or importer may use whatever scientifically valid data is available to evaluate the physical hazards of the mixture.
- If there is evidence that a component is present at less than one percent (< 0.1% for carcinogens) and could be released into the workplace environment in concentrations that would exceed an OSHA PEL or ACGIH TLV, or present a health hazard in those concentrations, the mixture is assumed to present the same hazard.
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What is Involved in the Conduct of a Hazard Determination?
All possible physical or health hazards that might be associated with a chemical's use must be considered. The hazard determination process consists of four main steps:
- Selection of chemicals to evaluate;
- Collection of data;
- Analysis of the collected data; and
- Documentation of the hazard determination process and the results obtained.
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Written procedures generally describe the process followed; they do not have to address, individually, each chemical evaluated. If no hazards are found, the manufacturer, importer, or employer is not required to take further action pertaining to the evaluated chemical. Even if no hazards are found, however, documentation of the steps taken to evaluate the chemical (and any retrieved data) may be useful for future reference.
For most of the chemicals specifically designated as hazardous in the HCS, the available information has been compiled in readily available and reliable sources (see Appendix B). If a chemical is not specifically designated as hazardous, you must collect and evaluate the data and determine if the chemical is hazardous. The hazard determination for these chemicals may be more involved since reliable data compilations may not exist. The determination in this case requires a more exhaustive search
for information.
In some cases, a chemical may possess a single hazard. In other cases, several hazards may be associated with exposure to a chemical. Hazards can range from mild to severe. For example, the identified hazard for acetic acid, as normally used in industry, is irritation (sensory and respiratory). In contrast, exposure to lead may involve several health hazards, including neurotoxicity, blood effects, cardiovascular damage,and kidney damage, and birth defects.
The hazard evaluation is a process that relies heavily on the professional judgmentjudgment of the evaluator, particularly in the area of chronic hazards. The performance-orientation of the HCS does not diminish the duty of the chemical manufacturer, importer or employer to conduct a thorough evaluation, examining all relevant data and producing a scientifically defensible evaluation.
First Step
Prepare a chemical inventory
SELECTION OF CHEMICALS
The ultimate goal in the hazard determination process is to know and document the hazards of all covered chemicals you manufacture or import. In order to achieve this you must first determine which chemicals require a hazard determination. The logical way to do this is to first prepare an inventory of all chemicals manufactured or imported. Items exempted from coverage under the HCS may be excluded from the inventory. For chemicals obtained from suppliers, you may rely upon the
MSDSs and labels provided by the chemical manufacturer or importer. However, you may choose to conduct hazard determinations for those chemicals if you are concerned about the adequacy of the hazard information you have received.
The inventory should anticipate the full range of downstream uses of the products and account for any hazardous by-products which may be formed. For example, a manufacturer of gasoline must inform downstream users of the hazards of carbon monoxide, since carbon monoxide is a hazardous chemical and is "known to be present" as a by-product resulting from the use of gasoline. Similarly, manufacturers of diesel must inform downstream users of the potential human carcinogenicity of diesel exhaust
on the MSDSs for diesel fuel.
If an inventory is not already in place, a good start could be to review purchase orders to create an initial inventory. Next, one should conduct an inspection of all areas noting any additional chemicals present that should supplement the initial inventory. It would be ideal to note the location and quantity of each chemical found. Chemical inventories are often maintained as computer files for ease and efficiency in keeping them current. With knowledge of the chemicals
in your possession, hazard determinations can now be performed for chemicals in the inventory.
DATA COLLECTION
What data should be collected?
Where can I find the data?
The second step in the hazard determination process is data collection. There are two main questions to be answered: 1) what type of data should be searched for and collected; and 2) how do I go about finding sources that might contain the desired data? You should recognize that the hazard determination process involves the identification of all of the hazards associated with a chemical, not just some of them. This process must be completed even though some data elements may
be difficult to locate. Any hazard that exists for the chemical must be identified and communicated to downstream employers and employees.
To complete the hazard identification, information is needed in three categories:
- chemical identity;
- chemical and physical properties; and
- health effects.
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There are numerous sources that could be searched for this information. A first step is to consult For practical reasons, one should first go to the primary sources (of information such as Wexler's Encyclopedia of Toxicology)those listed in Appendix B. Theose sources have already compiled data pertaining to many chemicals and are considered generally reliable. If that search fails to provide the needed data for your chemicals, you may need to search the secondary or computerized
literature sources or computerized literature sources. A number of these additional sourcesthat are also listed in Appendix B. For new or less commonly -used chemicals, there may not be much data available in any of these sources. In suchome cases, especially if a new chemical is formed, your company may have to sponsor testing to determine the potential for physical or health hazards, since it may no longer be assumed that the new chemical has the same intrinsic hazards as its components. Such
situations are beyond the scope of this documentyou may choose to test the chemical to determine chemical and physical properties and identify hazards.
In the sections that follow, a discussion of data needs for the three categories of information is provided. Also, a few recommended key references for the various types of data are listed. You should recognize that complete and reliable data must be entered on MSDSs and labels in order to meet HCS requirements. Before the search for hazard data can begin, however, you must identify the exact chemical composition of the chemical(s) or products manufactured or imported. For mixtures or products,
this chemical search includes the name of each chemical in the mixture, including active ingredients, inactive ingredients, and impurities.
The specific chemical identity of all chemicals on your Chemical Inventory should be carefully and completely compiled. The specific chemical identity should include:
- the chemical name along with common name and synonyms;
- the Chemical Abstracts Services (CAS) Registry Number (if available); and
- any other information that reveals the precise chemical designation and composition of the substance.
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Correct identification of chemicals is critical for data retrieval. Use the precise chemical name and CAS number when searching for information
An example of the type of chemical identification data needed is presented for Perclene®, a widely used industrial solvent. Perclean® is a trade name for perchloroethylene or Perc (common name), or more specifically tetrachloroethylene (the actual chemical name (CAS id="_x0000_s1071" Number 127-18-4). To avoid confusion, literature is often indexed using the CAS number or the primary chemical name. Thus, the most effective search of computerized
databases is conducted using tetrachloroethylene and/or CAS NNumber 127-18-4. Several databases exist that can be searched for the CAS number or chemical name if one only has a trade or common name. Another problem with the use of common names is that they may be used for more than one substancemolecular entity. TCE is sometimes used as an acronym for tetrachloroethylene, although it more frequently refers to trichloroethylene. Therefore use of the exact chemical name or CAS number would avoids
confusion and erroneous data retrieval. The CAS number is unique for each chemical and should be used, along with the chemical name, when searching computerized databases for information on a specific chemical.
The percent composition should be available in-house for all chemicals and products manufactured or, imported, or used in your business. The chemical composition information should be based on an analysis of the final or technical product. A technical grade product is not usually a pure substance and often contains other chemicals such as stabilizers, solvents, carriers, "inert" ingredients, or impurities. For the hazard evaluation process, these other chemicals must also be examinedlisted if
they are more than 1.0% of the composition for non-carcinogenic substances or 0.1% of the product if the substance is a carcinogen.
Thus, the initial step is to collect as much data as possible pertaining to the physical and chemical properties and toxicity data for chemicals on your Chemical iInventory.
Key sources of information related to chemical identification are:
- Company Records;
- MSDSs and product safety bulletins from manufacturers or suppliers;
- OSHA Chemical Information Manual/Database; The Merck Index; ChemID; and
- Trade Associations.
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Physical and Chemical Properties
A chemical may possess more than one physical or health hazard.
The physical properties of a substance can be directly related, in many cases, to the probability of the substance representing a physical hazard. However, the fact that a substance has a certain physical property can not necessarily be used to necessarily predict a physical hazard. For example, all volatile substances are not necessarily explosive. Some solids can also be explosive, (e.g., TNT or grain dust particles). Nevertheless, knowing the physical properties does have
great value in predicting whether a substance may be a physical hazard.
Key sources of information related to physical and chemical properties include:
- NFPA Fire Protection Guide to Hazardous Materials;
- Department of Transportation 2000 Emergency Response Guidebook;
- Hazardous Substances Data Bank (HSDB);
- PMSDSs and product safety bulletins from manufacturers or suppliers;
- The Merck Index;
- NIOSH Pocket Guide to Chemical Hazards;
- CRC Handbook of Chemistry and Physics;
- Bretherick's Handbook of Reactive Chemicals Hazards; and
- Trade Associations.
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Health Effects
All potential health hazards must be determined - not just those identified by OSHA
The HCS includes ahas list ofed 14 potential health hazards, as well asas defined the criteria for determining when a chemical represents a health hazard (see Section 3). In many cases, a chemical may pose more than one type of health hazard. If your cCompany is manufacturesing a new chemical you may be required tothey must submit premanufacture health effects data to the EPA to comply with the Toxic Substances Control Act (TSCA). Data submitted by other companies may be available
from the EPA. Thisose assessment and supporting data should also be available in your Company's Hazard Communication Program, as this information is used forused to assist with hazard determination and the preparation of MSDSs and labels. Data submitted to EPA by other companies may be available to you by contacting the EPA. For chemicals that have not been studied in-house or via company-sponsored contract toxicology studies, the company should seek toxicity data from the literature, government,
or private sources. Some recommended reference sources are listed below.
- Company-sponsored research;
- PMSDSs and product safety bulletins from manufacturers, or suppliers, or Internet sites;
- Hazardous Substances Data Bank (HSDB);
- Registry of Toxic Effects of Chemical Substances (RTECS®);
- NIOSH Pocket Guide to Chemical Hazards;
- OSHA Chemical Information Manual/Database;
- IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to man;
- NTP Annual Report on Carcinogens;
- ACGIH TLVs and BEIs;
- Hawley's Condensed Chemical Dictionary, 14th Edition;
- Sax's Dangerous Properties of Industrial Materials, 10th Edition;
- Published Literature; and
- Trade Associations.
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DATA ANALYSIS
The third step in the hazard determination process is data analysis. This step is the most demanding in technical expertise. The HCS requires that chemical manufacturers and importers conduct a hazard determination to determine whether physical or health hazards exist. In some cases, especially for physical hazards, a definition in the HCS establishes the criteria to be followed. For example, if a liquid has a flash point below 1000 F, it is by definition a "flammable
liquid". This type of procedure is a simple data analysis. You can look up the flash point in a standard reference and accept it at face value. In the event your company is manufacturing or importing a chemical for which there is no information on the flash point, you may choose to determine the flash point by laboratory testing, but testing is not required by the HCS.
As a rule, the HCS attempts to minimize the burden of literature search and review while satisfying the need to provide information required to protect employees who are exposed to hazardous chemicals. For this reason, a suggested approach is to go to the most likely sources first to obtain the needed data, and then proceed to additional sources if necessary.
For health hazards, explicit criteria are provided in the HCS for some health hazards. For example, criteria are given for classifying a chemical as highly toxic or toxic based on acute effects, and for designating a chemical as a carcinogen. For other health hazards, a simple generic requirement is provided for the determination of a specific health hazard. The HCS states that "evidence that is statistically significant and which is based on at least one positive study conducted in accordance
with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the [HCS] definitions of health hazards."
Let's examine this requirement further. There are three key criteria that must be met, namely "statistically significant", "positive study", and "established scientific principles". Thus, the evaluation of study results requires some knowledge of statistics, commonly accepted scientific test methodology, and the definitions of health hazards.
Statistical significance is a mathematical determination of the confidence in the outcome of a test. The usual criterion for establishing statistical significance is the p-value (probability value). A statistically significant difference in results is generally indicated by p<0.05. By p<0.05, there is less than 5% probability that the toxic effects observed were due to chance and were not caused by the chemical. Another way of looking at it is that there is a 95% probability that the effect
is real, i.e., the effect seen was the result of the chemical exposure.
The other major indication of statistical significance is the 95% confidence level for a specific data point. Most reports of toxicity testing will include some information on the confidence in the data. For example, an LD50 with a listed value of 9.5 ? 1.2 indicates that if the same study were to be repeated many times, the LD50 would be expected to be within the range of 8.3 - 10.7 on 95 out of every 100 times.
Most toxicity and epidemiology reports will provide an analysis of the data and conclude whether the results were positive or negative, or will describe the adverse effects observed at specific dose levels. By positive, this means that the exposed humans or animals were more likely to develop toxic effects than the non-exposed population. Normally, the investigator's statistical analysis and conclusions can be accepted.
Hazard evaluation relies on professional judgment, particularly in the area of chronic hazards. The performance-orientation of the HCS does not diminish the duty of the chemical manufacturer, importer or employer to conduct a thorough evaluation, examining all relevant data and producing a scientifically defensible determination.
In the remainder of this section, an overview is presented of the HCS designated hazards and their definitions. In addition, a brief discussion is presented to further explain the specific hazard and procedures that can be used to analyze the data. Because this document can only present a limited discussion of the various hazards, you are encouraged to consult references that go into greater detail (see Appendix B of this document).
Physical Hazards
A chemical is a physical hazard if it:
- is likely to burn or support fire;
- may explode or release high pressures that can inflict body injury; or
- can spontaneously react on its own, or when exposed to water.
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Fire Hazards
Flashpoint is the primary measure of a liquid chemical's propensity to burn.
Combustible and Flammable Liquids
The ability of a chemical to either burn or support burning is a potentially disastrous physical hazard. The two primary measures of the ease with which a liquid will burn are the flashpoint and auto-ignition temperature. The flashpoint is the lowest temperature at which a liquid will emit sufficient vapors to form an ignitable mixture with air. In contrast, auto-ignition is the characteristic of a material in which it will spontaneously burn without the aid of an ignition source,
such as a spark or flame. Many agents will burn when ignited whereas there are only a few that will spontaneously erupt into flames. While no single measure of flammability is sufficient for all purposes, the most commonly found measure in the literature is the flashpoint. For this reason, HCS uses flashpoint in classifying the fire hazard of a chemical.
Flammable liquids and combustible liquids are discussed together since flashpoint is the criteria for classification of both. The only difference between a "flammable" and "combustible" liquid is the relative ease (temperature) with which the substance burns or supports burning. The data analysis and hazard categorization are clear. For a pure chemical compound, the assignment to combustible or flammable liquid categories is quite simple:
- if the flashpoint is between 1000F - 2000F (37.8oC - 93.30C), it is a combustible liquid;
- if the flashpoint is below 100oF (38oC), it is a flammable liquid.
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The HCS definition for combustible liquid is "any liquid having a flash point between 100oF (37.8oC) and 200o F (93.3oC), except any mixture having components with flashpoints of 200oF (93.3o C) or higher, the total volume of which makes up 99 percent or more of the total volume of the mixture."
The HCS definition for flammable liquid is "any liquid having a flash point below 100oF (38oC), except any mixture having components with flashpoints of 100oF (38oC) or higher, the total of which make up 99 percent or more of the total volume of the mixture."
You see that HCS has made exceptions for chemical mixtures. A mixture will not be categorized as a combustible liquid so long as less than 1% of the total volume of components have flashpoints between 100o and 200o F. For example, if Chemical A has a flashpoint of 1800 F and represents 0.5% of the mixture and all other chemicals have flashpoints above 2000 F, then the mixture is not considered a combustible liquid. Similarly, a mixture will not be categorized as a flammable liquid if it is composed
of at least 99% (by volume) of components with flash points above 100oF (38oC). Many mixtures will contain more than 1% of a flammable liquid and the mixture will have a flash point above 100oF. Where data indicating the flashpoint of a chemical is not available, you may choose to test the chemical to determine the flashpoint.
When a substance flashes, the resulting flame will spread through the vapor from the ignition source to the nearby surface of the liquid. From a practical viewpoint, a flammable liquid is potentially more hazardous than a combustible liquid. A flammable liquid presents a fire hazard if present in an open container near an ignition source in an environment in which the temperature is at or below normal room temperature. Examples of flammable liquids (with flash point temperatures) are: acetone (00F),
ethyl ether (-490 F), ethyl alcohol (550 F), and gasoline (-450 F). For a combustible liquid to present a fire hazard it must be above normal room temperature. Examples of combustible liquids are kerosene (1000-1620F) and Stoddard solvent (1020-1100F).
The HCS definition for flammable aerosol is "an aerosol that, when tested by the method described in 16 CFR 1500.45, yields a flame projection exceeding 18 inches at full valve opening, or a flashback (a flame extending back to the valve) at any degree of valve opening."
The analysis as to whether the chemical is a flammable aerosol is more difficult and usually must be based upon laboratory testing of the aerosol as emitted from a pressurized container. In practice, most aerosols are mixtures, usually in air, and are primarily propellant formulations of droplets, particles, gases, and/or vapors. Their flammability is highly dependent on the nature of the propellant formulation. Unless data obtained from a literature search pertains to the exact mixture of ingredients
in the product, the data may not be accurate. In the event that you choose to test a chemical product to determine if it is a flammable aerosol, the method described in 16 CFR 1500.45 should be used. A positive test is obtained if a flame is projected at least 18 inches at full valve opening, or if there is a flashback (i.e., a flame extends back to the valve) at any degree of valve opening.
Flammable Gas
The HCS definition for flammable gas is "a gas that, at ambient temperatures and pressures, forms a flammable mixture with air at a concentration of less than thirteen (13) percent by volume; or forms a range of flammable mixtures with air wider than twelve (12) percent by volume."
Thus, a gas can be categorized as flammable if the gas:
- burns in air at a concentration of less than 13%; or
- has a lower flammability limit (LFL) of 13% or more with a concentration range for burning in air greater than 12%. The range is the difference between the LFL and the upper flammability limit (UFL).
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The LFL is the minimal concentration of vapor below which combustion will not occur even in the presence of an external ignition source, whereas the UFL is the maximum vapor concentration above which combustion cannot take place. To understand the concept, that at a certain concentration a gas will burn whereas it will not if the concentration is too low or too high, consider the carburetor of an automobile. The carburetor must be correctly adjusted so that the gasoline/air mixture
is not too lean or too rich, or the gasoline/air vapor mixture will not burn in the automobile engine. Gasoline has an LFL of 1.4% and an UFL of 7.6%.
Methane and butane are examples of flammable gases that burn at less than 13% concentration in air. Acetone is an example of a flammable liquid that volatilizes but does not represent a flammable gas. This is true because the LFL is 16% and the UFL is 25%, which is a difference of only 9% (the definition requires a difference of at least 12%). On the other hand, ammonia is categorized as flammable since it has a LFL of 15% and an UFL of 28%, a difference of 13%.
Flammable Solid
The HCS definition of a flammable solid is "a solid, other than a blasting agent or explosive as defined in [29 CFR] 1910.109(a), that is liable to cause fire through friction, absorption of moisture, spon¬taneous chemical change, or retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious hazard. A chemical shall be considered a flammable solid if, when tested
by the method described in 16 CFR 1500.44, it ignites and burns with a self¬-sustained flame at a rate greater than one ¬tenth of an inch per second along its major axis.”
The analysis as to whether a solid chemical will burn with such intensity to be classified as a flammable solid usually must be based upon the results of laboratory testing. If you choose to test a chemical to determine if it is a flammable solid, such testing should be conducted by the method described in 16 CFR 1500.44. A flammable solid can be ignited readily and then will burn so vigorously as to create a serious fire hazard. Blasting agents or explosives may be solids that burn but with an intensity
so great that they are classified as explosives. An example of a flammable solid that can be ignited by friction is the chemical formulation on the head of matches. Some metal powders (such as magnesium) can react with moisture and burn and are thus classified as flammable solids.
Oxidizer
The HCS classifies a chemical as an oxidizer if it is a "chemical other than a blasting agent or explosive as defined in [29 CFR] 1910.109(a), that initiates or promotes combustion in other materials, thereby causing fire either of itself or through the release of oxygen or other gases."
An oxidizing agent is a chemical or substance that brings about an oxidation reaction. The agent may provide the oxygen to the substance being oxidized (in which case the agent has to be oxygen or contain oxygen), or it may receive electrons being transferred from the substance undergoing oxidation (e.g., chlorine is a good oxidizing agent for electron-transfer purposes, even though it contains no oxygen).
Oxidizing materials can initiate or greatly accelerate the burning of fuels. The most common oxidizer is atmospheric oxygen. Oxygen-containing chemicals (e.g., hydrogen peroxide and nitrous oxide) and halogens (e.g., bromine, chlorine, and fluorine) can also be strong oxidizers. Some chemicals may be oxidizers with such an extremely fast burning potential that they are classified as explosives or blasting agents rather than oxidizers. Often the fact that a chemical possesses oxidizing potential can
be obtained from an examination of its chemical structure. For example, oxidizing substances usually include recognizable functional chemical groups, e.g., perchlorate (ClO4-), chlorate (ClO3-), chlorite (ClO2-), hypochlorite (ClO-), peroxide (-O-O-=), nitrate (NO3-), nitrite (NO2-), dichromate (Cr2O7=), persulfate (S2O8=), and permanganate (MnO4¬¬-).
While the potential for oxidizing can often be inferred by chemical structure, absolute certainty can only be properly verified in the laboratory since oxidation involves not only the oxidizing potential of the oxidizer, but also the chemical formulation of the fuel to which it comes in contact. Oxidizers are classified by comparison with the oxidizing properties of a standard test chemical, ammonium persulfate, applied to dry, conditioned sawdust. A solid that promotes combustion of the conditioned
sawdust at a greater rate than ammonium persulfate is classified as an oxidizer.
Pyrophoric Hazards
The HCS definition for a pyrophoric chemical is "a chemical that will ignite spontaneously in air at a temperature of 130 F (54.40 C) or below." Fortunately, there are only a few chemicals that have the ability to catch fire without an ignition source when exposed to air. Many of these are elements (e.g., lithium, powdered aluminum, magnesium) or organometallic compounds (such as lithium hydride, diethyl zinc and arsine). Moisture in the air often increases
the probability of spontaneous ignition of pyrophoric materials.
Explosive Hazards
Compressed Gas
The HCS definition for Compressed Gas is:
(i) "a gas or mixture of gases having, in a container, an absolute pressure exceeding 40 psi at 700 F (21.10 C): or
(ii) a gas or mixture of gases having, in a container, an absolute pressure exceeding 104 psi at 1300 F (54.40 C) regardless of the pressure at 700 F (21.10 C); or
(iii) a liquid having a vapor pressure exceeding 40 psi at 1000F (37.80 C) as determined by ASTM D-323-72." |
All compressed gases are potentially hazardous since they are under great pressure in a container. Accidental rupture of the container and the rapid release of the pressurized gas can result in injury to persons and damage to objects in the vicinity. Not only can the gas be released with great force, but the force of the release may propel the container for a long distance. In addition to the mechanical hazard from the pressure or propelled container, other hazards may exist
from the released gas. The hazard from some compressed gases may be strictly mechanical (e.g., compressed air and nitrogen), others may possess other types of hazards, such as being flammable (e.g., methane and propane) or toxic (e.g., ammonia and chlorine).
Explosive
The HCS definition for explosive is "a chemical that causes a sudden, almost instantaneous release of pressure, gas, and heat when subjected to sudden shock, pres¬sure, or high temperature."
Explosives are unstable materials and are of two types. One type consists of material capable of supersonic reactions (detonation), for example, nitroglycerine and TNT. The other type consists of materials (usually mixtures) that burn rapidly but at a subsonic rate. Examples of this type are gunpowder, rocket propellants, and pyrotechnic mixtures (fireworks). The difference between fire and explosion is the rate at which high temperature gases are produced and the physical containment of the burning
gases. When high temperature gases build up extremely fast, there can be such a sudden release of energy from the gases that a shock wave or explosion is created. Confining the build-up of high pressure gases in a drum or vessel, which prevents venting of the gases, may promote an increase in the pressure within the restricted volume until an explosion occurs. Such is the principle behind some munitions, which confine high pressure gases until the pressure exceeds the strength of the casing.
Most explosives have a chemical structure that contains both oxidizing and fuel functional groups. Examples of functional groups contained in explosives are: azides, dizonium, and styphnate. While the presence of such functional groups suggests explosive potential, it is usually necessary to confirm this hazard via experimental studies.
Reactive Hazards
These reactionary materials can cause damage to the human body by release of gases that will burn, explode, or produce high pressure that can inflict injury to a person nearby. In some cases, the reactionary materials may release substances that are considerably more toxic than themselves. HCS has defined three types of reactive hazards: organic peroxides, unstable (reactive) materials, and water-reactive materials.
Organic Peroxide
The HCS definition for organic peroxide is "an organic compound that contains the bivalent -O-O structure and which may be considered a structural derivative of hydrogen peroxide where one or both of the hydrogen atoms has been replaced by an organic radical."
The peroxide functional group (-O-O) is relatively unstable and most organic peroxides will spontaneously decompose at a slow rate. Some organic peroxides, however, are capable of very violent reactions with detonation at environmental temperatures, causing fires and explosions. Several organic peroxides are used in the plastics industry to initiate polymerization and serve as cross-linking agents. Recognizing an organic peroxide is quite simple - the presence of the peroxide group (-O-O) in its chemical
structure. However, the characterization of the severity of the hazard is usually based upon fairly extensive laboratory testing. Examples of organic peroxides are benzoyl peroxide and allyl hydroperoxide.
Unstable (Reactive) Material
The HCS definition for an unstable (reactive) material is a "chemical which in the pure state, or as produced or transported, will vigorously polymerize, decompose, condense, or will become self-reactive under conditions of shocks, pressure or temperature."
The main difference between an unstable material and an explosive is the rate of the reaction. While the rate of reaction for unstable materials is less than in the case of explosives, the unstable materials can still present a serious hazard due to the generation of high temperatures and pressures. In some cases, the reaction may be rapid enough to approach explosive potential.
Polymerization is a reaction in which small molecules (usually monomers) react with each other to form larger molecules (polymers). In the chemical process, a large amount of heat may be released. This raises the temperature of the monomer mixture that further accelerates the polymerization process until the reaction runs away or explodes.
Decomposition reactions can occur with many chemicals and mixtures. In this process, complex molecules dissociate to form simpler substances. This process may require input of heat or there may be a release of heat during the chemical reaction. The most hazardous reactions are those in which heat is released. If the reactions take place within a vessel, the high temperature may increase the vessel pressure to the point it ruptures or explodes. Examples of unstable materials are acrylonitrile and butadiene.
Water-Reactive Material
The HCS definition for water-reactive material is a "chemical that reacts with water to release a gas that is either flammable or presents a health hazard."
Many chemicals fall in this category. For example, sodium and potassium, when exposed to water, will react and release hydrogen presenting an explosive hazard. Carbides (e.g., calcium carbide) can generate acetylene, a highly flammable gas, when exposed to water. In other cases, the gases released may be highly toxic as in the case of cyanide that can be released when an inorganic salt containing cyanide (e.g., potassium cyanide) comes in contact with water.
Health Hazards
To define with precision every possible health effect that can occur in the workplace as the result of chemical exposure is an unrealistic goal. There can be a variety of toxic effects on different organs, which may depend upon dose level, frequency, duration, and route of exposure. This does not negate the need for employees to be informed of such effects and be protected from them. The HCS provides a list of the most common health hazards. However, it should be stressed that
the list does not include all health hazards.
Some of the health hazard definitions provide for an extremely precise testing procedure (e.g., test species or weight range). This is because those test protocols had been codified in previous government regulations. However, other test methods have been developed and are acceptable for hazard determination. In view of this, Appendix A of the HCS indicates that if there are available scientific data that involve other animal species or test methods, they must also be evaluated to determine their
applicability.
Assigning chemicals to discrete health hazard categories is not precise, and several schemes have been proposed. Separation into acute and chronic health hazards is used by the American National Standards Institute (ANSI) in its labeling standard (ANSI Z129.1). The main difference between acute and chronic is related to duration of exposure and to the rapidity of onset after exposure.
In some exposure situations, the effects may occur rapidly after a single or short-term exposure (acute effects); in other cases, the damage may accumulate after multiple exposures or over a long exposure period, or arise long after earlier exposures (chronic effects). Examples of chronic effects are cancer and cirrhosis of the liver. A chemical may have the ability to cause both acute and chronic effects. For example, ethyl alcohol can cause death when consumed in large amounts at one time, birth
defects when consumed for only a few days by a pregnant woman, and cirrhosis of the liver if consumed for several years. OSHA has listed a number of health hazards, some general or systemic (whole-body) effects, and others that are specific to certain organs (target organs).
Following is a brief description of the HCS identified health hazards. In many cases, the determination is based on data obtained from standard experiments with laboratory animals. Reliable human data is prefered to animal data. However, in many cases, reliable human data are not available, and animal data must be used. The search strategy previously discussed should attempt to obtain human data, animal data, and cell and tissue studies, as well as data on the mechanisms by which a chemical causes
toxicity.
Systemic Effects
Carcinogen
Under the HCS, “a chemical is considered to be a carcinogen if:
(a) It has been evaluated by the International Agency for Research on Cancer (IARC), and found to be a carcinogen or potential carcinogen; or
(b) It is listed as a carcinogen or potential carcinogen in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition); or,
(c) It is regulated by OSHA as a carcinogen." |
Probable human carcinogens have been listed by OSHA, NTP, and IARC.
OSHA has accepted the prior hazard determination of these expert organizations that have reviewed the human and animal research studies and have concluded that the chemicals listed represent human cancer risks.
As might be expected, there is considerable overlap in these lists as more than one of the scientific organizations may have come to the same conclusion regarding cancer potential. Some examples of workplace carcinogens are asbestos, benzene, lead chromate, beryllium and vinyl chloride.
The simple definition of a carcinogen is "a substance that has the potential to cause cancer." The terminology used to describe cancer may be confusing. Cancer is a type of tumor. A tumor (also known as a neoplasm) is simply an uncontrolled growth of cells. Tumors may be benign or malignant. Benign tumors grow only at the site of origin, and do not invade adjacent tissues or go to distant sites in the body (known as "metastasis"). Except for those that develop deep in vital organs
(such as the brain), benign tumors can be successfully treated (usually by surgical removal) and the potential for causing death is low. Malignant tumors are cancers and can grow outside their original site in an organ, invade surrounding tissue, or metastasize to distant organs where they can start new growths of the cancerous tissue. Malignant tumors (cancer) are difficult to treat and frequently cause death of the patient.
Cancers vary greatly in type and behavior in the body. Some cancers grow slowly and rarely metastasize. Others are highly invasive and metastasize rapidly. Cancers are usually named for the specific cell type or organ of origination. For example, squamous cell carcinoma of the lung is a cancer that arose from a squamous cell in the lung. A hepatocellular carcinoma is a cancer arising from a liver cell (hepatocyte). Sometimes the name given to a cancer also reflects its nature. For example, chronic
lymphocytic leukemia is a cancer involving lymphocytes (a type of blood cell) which the leukemia is chronic or long-lasting in nature. OSHA, NTP, and IARC report the specific types of cancer caused by chemicals that they list.
How does IARC, NTP, and OSHA classify a substance as a "Carcinogen"?
The operational criteria for labeling or designating a substance as a "carcinogen", as used by the IARC, NTP, and OSHA, relate strictly to the substance's potential for causing cancer in humans. The finding that a substance produced cancer in an experimental animal study does not necessarily result in IARC, NTP, or OSHA designating the substance as a "human carcinogen." These organizations use a "weight of evidence" analysis which includes review
of data from animal studies, human epidemiological evidence, and data from cell and tissue studies.
In some cases the collective evidence is substantial and the substance is designated as a "known human carcinogen." In other cases the evidence for human carcinogenicity is not as strong and the substance warrants designation only as a "potential" or "possible" human carcinogen. In the HCS definition of "carcinogen", the terms "carcinogen" and "potential carcinogen" are used. "Carcinogen" in HCS terms relates to the IARC category
"Group I - The Agent is Carcinogenic to Humans, and the NTP category for "Substances …Known to be Carcinogenic."
"Potential carcinogens" in HCS terms relates to the IARC category "Group 2A - The Agent is Probably Carcinogenic to Humans", and to the NTP category for "Substances …Which May Reasonably be Anticipated to be Carcinogens."
IARC has a third classification of concern to OSHA. This is Group 2B - "The Agent is Possibly Carcinogenic to Humans." This classification does not rise to the level of concern for Group 2A and therefore those substances are not designated as OSHA carcinogens and the labels for those substances do not require labeling as a carcinogen. However, the fact that IARC has placed a substance into Category 2B should be included on material safety data sheets.
Reports in the periodic literature (e.g., journals) or laboratory reports (e.g., NTP bioassay reports) may indicate positive results from cancer studies of chemicals not listed by OSHA, NTP, or IARC as carcinogens. Some literature reports lack information on experimental design, age of individual animals when tumors were found, purity of chemical tested, etc., making scientific analysis difficult and uncertain. For this reason, a "weight of evidence" approach is used to evaluate the strength
of evidence pertaining to human carcinogenicity. The recommended approach is not to discard such information but to collect and make it a part of the information profile for the substance. The results of such studies should be listed on the MSDS. However, the positive results are not sufficient to designate the substance as a carcinogen (and to label it as such). The carcinogen designation is reserved for those substances that have been so designated by IARC, NTP, or OSHA.
Toxic Agents
The HCS classifies chemical agents as toxic or highly toxic based on the number of deaths that occur following brief (acute) exposure of rodents. The difference in the two categories is strictly the dose at which the toxicity (death) occurs. Exposure is by the three major workplace exposure routes, mouth (oral), skin (dermal), or breathing (inhalation). The analysis is based on the LD50 (median lethal dose by oral or dermal exposure) and LC50 (median lethal inhalation concentration for a one-hour
exposure. The LD50 and LC50 represent the dose or concentration, respectively, at which 50% of the test animals (and supposedly humans) will be expected to die.
Under the HCS, a highly toxic chemical is "a chemical falling within any of the following categories:
(a) A chemical that has a median lethal dose (LD50) of 50 milligrams or less per kilogram of body weight [units listed as mg/kg] when administered orally to albino rats weighing between 200 and 300 grams each.
(b) A chemical with a median lethal dose (LD50) of 200 milligrams or less per kilogram of body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with the bare skin of albino rabbits weighing between two and three kilograms each.
(c) A chemical that has a median lethal concentration (LC50) in air of 200 parts per million (units listed as ppm) by volume or less of gas or vapor, or 2 milligrams per liter [units listed as mg/l] or less of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within one hour) to albino rats weighing between 200 and 300 grams each." |
Under the HCS, a toxic chemical is The HCS definition for Toxic is "a chemical falling within any of the following categories:
(a) A chemical that has a median lethal dose (LD50) of more than 50 milligrams per kilogram but not more than 500 milligrams per kilogram of body weight when administered orally to albino rats weighing between 200 and 300 grams each.
(b) A chemical that has a median lethal dose (LD50) of more than 200 milligrams per kilogram but not more than 1,000 milligrams per kilogram of body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with the bare skin of albino rabbits weighing between two and three kilograms each.
(c) A chemical that has a median lethal concentration (LC50) in air of more than 200 parts per million but not more than 2,000 parts per million by volume of gas or vapor, or more than two milligrams per liter but not more than 20 milligrams per liter of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within 1 hour) to albino rats weighing between 200 and 300 grams each." |
The following table illustrates how a chemical can be classified as a Highly Toxic or Toxic depending on the results of the appropriate animal tests.
| Animal Test |
Highly Toxic |
Toxic |
| Oral LD50 |
£ 50 mg/kg |
50-500 mg/kg |
| Dermal LD50 |
£ 200 mg/kg |
200-1000 mg/kg |
| Inhalation LC50 - gases, vapors |
£ 200 ppm |
200-2000 ppm |
| Inhalation LC50 - mists, fumes or dust |
2 mg/L |
2-20 mg/L |
Remember the HCS instructions pertaining to whether a study is scientifically acceptable for hazard determination. While only one positive study is required, it must be:
- conducted in accordance with established scientific principles; and
- the results must be statistically significant.
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As can be seen, the acute toxicity for a toxic agent is considerably less than with the highly toxic agents. For example, the break point for oral exposures is 50 mg/kg. Below 50 mg/kg, the chemical is highly toxic whereas if the LD50 is above 50 mg/kg, it is only toxic. Examples of highly toxic chemicals are parathion (with an oral rat LD50 of 2 mg/kg and a dermal LD50 of 22 mg/kg) and methyl isocyanate (with an inhalation one-hour
LC50 in rats of 45 ppm). Examples of toxic chemicals are chloroform (with an LD50 of 140 mg/kg), acrylonitrile (with an 24-hour dermal LD50 between 200 and 2000 mg/kg), and ammonia (with an inhalation one-hour LC50 in rats between 200 ppm and 2000 ppm). Agents having an oral LD50 greater than 500 mg/kg are not classified as toxic. This does not mean that they do not represent a health hazard (e.g., the chemical could present a chronic hazard, such as cancer or hepatotoxicity), but
only that they are not classified as toxic under the HCS.
While these criteria are based on laboratory animals that are quite different than humans, the relative response between animals and humans is generally comparable on a per body weight basis. Thus, expressing the effect in terms of kilogram of body weight provides a satisfactory basis for determining potential human effects based on animal research results. Translating a 50 mg/kg LD50 to an understandable situation in humans, if a group of 150-pound humans ingested about one-half teaspoon of such
a chemical, approximately 50% would be expected to die.
The HCS provides criteria for classifying chemicals as highly toxic and toxic based on experiments that used 200-300 gram albino rats or 2-3 kilogram albino rabbits. However, current testing procedures accept other species and do not prescribe exact weights. Although specific criteria are provided, the HCS also indicates that information pertaining to other species and test methods is also relevant. In determining hazards, you need to search for and analyze all data pertaining to
toxicity and make judgments as to whether the tests were conducted using appropriate and accepted methodology. If the studies are acceptable, the data should be used as appropriate to determine whether the chemical is highly toxic, toxic, or belongs to another health hazard category (e.g., hepatotoxicity or irritant).
Irritant
Irritant - reversible inflammatory reaction
Under the HCS, an irritant is "A chemical, which is not corrosive, but which causes a reversible inflammatory effect on living tissue by chemical action at the site of contact. A chemical is a skin irritant if, when tested on the intact skin of albino rabbits by the methods of 16 CFR 1500.41 for four hours exposure or by other appropriate techniques, it results in an empirical score of five or more. A chemical is an eye irritant if so determined under the procedure listed
in 16 CFR 1500.42 or other appropriate techniques."
The difference between an irritant and a corrosive is the ability of the body to repair the tissue reaction. With irritants the inflammatory reaction can be reversed whereas with corrosive damage it is permanent or irreparable. The site of irritation is often the skin or eye but can also be any mucous membrane or other tissue that the chemical comes in contact with. This could include the mouth or throat if the irritant is swallowed, and the nose or lungs if the irritant is inhaled. If an immunologic
mechanism (allergy) is responsible for the tissue reaction, the material will be classified as a sensitizer rather than an irritant. Examples of irritants are acetic acid, ammonia, and isopropyl alcohol. The standard toxicology test for inflammation consists of the application of a substance to the shaved skin of white rabbits. White rabbits have been widely used as the irritation is easy to detect and the results have been shown to be highly predictive of potential skin effects in humans. Data obtained
with other strains or species can also be used in the determination of irritation potential.
Corrosive
Corrosion - irreversible tissue injury
The HCS definition for corrosive is "A chemical that causes visible destruction of, or irreversible alterations in, living tissue by chemical action at the site of contact. For example, a chemical is considered to be corrosive if, when tested on the intact skin of albino rabbits by the method described by the U.S. Department of Transportation in appendix A to 49 CFR part 173, it destroys or changes irreversibly the structure of the tissue at the site of contact following
an exposure period of four hours. This term shall not refer to action on inanimate surfaces.”
Corrosion is manifested by ulcers, cell death, and scar formation. The site of a corrosive effect can be any place on the body that the chemical contacts. This is often the skin or eye but can also be any mucous membrane (such as the mouth or esophagus if swallowed and the nose and trachea if inhaled).
Generally speaking, corrosive materials have a very low pH (acids) or a very high pH (bases). Strong bases are usually more corrosive than acids. Examples of corrosive materials are sodium hydroxide (lye) and sulfuric acid.
The standard toxicology test for corrosivity uses white rabbits with the material applied to the shaved (but not damaged) skin. Experience has shown that results obtained with white rabbits are highly predictive of potential skin effects in humans. Corrosion determined using other species and procedures must also be considered in the decision as to classification as a corrosive.
Sensitizer
Sensitizer - produces hyperallergic condition
The HCS definition for sensitizer is "A chemical that causes a substantial proportion of exposed people or animals to develop an allergic reaction in normal tissue after repeated exposure to the chemical."
A sensitizer (allergen) causes little or no reaction in man or test animals on first exposure. The problem arises on subsequent exposures when a marked immunological response occurs. The response is not necessarily limited to the contact site as it may be a generalized body condition. Skin sensitization is common in industry. Respiratory sensitization and generalized hyperallergy to a few chemicals has also been known to occur. Well-known examples of sensitizers are toluene diisocyanate, nickel compounds,
and poison ivy.
Target Organ Effects
Hepatotoxin
Hepatotoxin - liver toxin
The HCS definition for hepatotoxins is “chemicals which produce liver damage”. Signs of hepatotoxicity may include jaundice and liver enlargement. Hepatotoxicity includes not only the liver but also the gall bladder and bile duct. The liver is particularly susceptible to foreign chemicals because of its large blood supply and the major role it plays in metabolism. These factors can result in exposure to high doses of a toxicant and the production
and immediate exposure to potentially toxic metabolites.
The primary forms of hepatotoxicity are: chemical hepatitis (inflammation of the liver), fatty liver or steatosis (lipid accumulation in hepatocytes), hepatic necrosis (death of the hepatocytes), cholestasis (stoppage of bile flow and backup of bile salts in the liver), cirrhosis (chronic fibrosis, often due to alcohol), hypersensitivity (immune reaction resulting in hepatic necrosis) and hepatic cancer (cancer of the liver). Examples of hepatotoxins are arsenic, carbon tetrachloride, ethyl alcohol,
halothane, and vinyl chloride.
Nephrotoxin
Nephrotoxin - kidney toxin
The HCS definition for nephrotoxins is “chemicals which produce kidney damage”. Signs often include edema and proteinuria. The kidney is highly susceptible to toxicants for two reasons. There is a very high volume of blood flow through the kidney, and the kidney can filter large amounts of toxins that can concentrate in the kidney tubules. The kidney eliminates body wastes, maintains body levels of electrolytes and fluids, and produces special enzymes
and hormones that regulate blood pressure, pH, calcium, and the production of red blood cells. Thus, the effects of nephrotoxicity are systemic in nature, such as hypertension, body fluid and electrolyte imbalance, and anemia. The primary forms of nephrotoxicity are nephritis (inflammation of the kidneys), glomerulonephritis (damage to the glomerulus portion of the nephron), and acute or chronic renal failure.
Examples of nephrotoxins are heavy metals (e.g., chromium, lead, mercury, and uranium) and halogenated hydrocarbons (e.g., carbon tetrachloride and chloroform). While some toxins cause acute effects, many exert their toxicity by long-term exposure at lower levels.
Neurotoxins
Neurotoxin - nervous system toxin
The HCS definition for neurotoxins is "chemicals which produce their primary toxic effects on the nervous system." The nervous system directs many of the body's activities so that changes in the nervous system may be apparent throughout the body. Electrical impulses move through the body via neurons (nerve fibers). Toxins can damage cells of the central nervous system (brain and spinal cord) or the peripheral nervous system (nerves outside the central nervous system).
The primary types of neurotoxicity are: neuronopathies (neuron injury), axonopathies (axon injury), demyelination (loss of axon insulation), and interference with neurotransmission. Signs and symptoms of neurotoxicity include narcoses, behavioral changes, and decreases in motor function. Examples of neurotoxins are carbon disulfide, ethylene oxide, hexane, lead, and mercury.
Blood/Hematopoietic Toxin
Hemotoxin - toxicity to bone marrow or circulating blood cells
Blood/hematopoietic toxins are also referred to as hemotoxins or hematotoxins. The HCS defines these chemicals as "Agents which act on the blood or hemato-poietic system: Decrease hemoglobin function; deprive the body tissues of oxygen."
While one might consider the blood and hematopoietic system as independent tissues, they are intimately related. The hematopoietic system gives rise to the blood elements (cells and platelets). Toxins can act at various points in the hematopoietic/blood system. Some affect the circulating blood elements interfering with their function. Others damage the hematopoietic system and may prevent it from producing the blood elements.
The formed elements (cells and platelets) in the circulating blood are usually not directly affected by toxins. An exception are the red blood cells (erythrocytes). Several toxic agents can bind with the hemoglobin of the red blood cells and interfere with transport of oxygen to body tissues (hypoxia). Examples of chemicals that bind with hemoglobin and cause hypoxia, by interfering with oxygen transporting capability of the blood, are carbon monoxide, sodium nitrite, and hydrogen sulfide. Cyanides
also cause hypoxia by interfering with the tissue cell's ability to utilize oxygen.
The more common form of hemotoxicity results from chemicals acting directly on the hematopoietic tissues (blood-forming tissue). The primary effect is a decrease in formation of specific blood cells so that the number in the circulating blood is reduced, impairing their ability to function normally. For example, phenothiazine and anticonvulsant drugs can damage the bone marrow cells that give rise to the granuloctyes and decreased ability to fight infections. Aspirin and nitroglycerin can be toxic
to megakaryocytes that produce blood platelets. The decrease in platelets impairs blood-clotting capability. Other toxins, e.g., arsenic, benzene, and chlordane can cause a decrease in the formation of all blood elements, a condition known as aplastic anemia. Cancer of the hematopoietic tissues (primarily acute myelogenous leukemia) also occurs due to exposure to some industrial chemicals and drugs, for example, benzene, chloramphenicol, and phenylbutazone.
Respiratory Toxin
Respiratory toxin - affects lung and other areas of respiratory system
The HCS definition for agents which damage the lung is “chemicals which irritate or damage pulmonary tissue.” These are commonly known as respiratory toxins.
The primary function of the respiratory system is to deliver oxygen to the bloodstream and remove carbon dioxide from the blood. Thus, damage to the respiratory tissues interferes with blood/gas exchange that may cause serious malfunction of all tissues of the body, especially the brain and heart. Respiratory toxicity can occur in the upper respiratory system (nose, pharynx, larynx, and trachea) or in the lower respiratory system (bronchi, bronchioles, and lung alveoli). The primary types of respiratory
toxicity are pulmonary irritation, asthma/bronchitis, reactive airway disease, emphysema, allergic alveolitis, fibrotic lung disease, pneumoconiosis, and lung cancer. Some exert their toxicity quickly (acute effects, such as pulmonary irritation) while others act over a long period to time (chronic effects, such as pulmonary fibrosis). Examples of respiratory toxins are asbestos, formaldehyde, ozone, nitrogen dioxide, and silica.
Reproductive Toxin
Reproductive toxicity - includes sterility, abortion, birth defects, child mortality and childhood cancer
The HCS definition for reproductive toxins is "chemicals which affect the reproductive capabilities including chromosomal damage (mutations) and effects on fetuses (teratogenesis)." This definition is comprehensive and incorporates toxic effects on all elements of the process of reproduction, including damage to the germ cells (sperm and ova).
Thus, a wide variety of effects can occur, including sterility, decreased libido, impotence, interrupted pregnancy (abortion, fetal death, or premature delivery), birth defects in the offspring, altered sex ratio and multiple births, chromosome abnormalities, childhood morbidity, and childhood cancer. Examples of reproductive toxins are lead and 1,2-Dibromo-3-chloropropane (DBCP). Reproductive toxicity can involve toxicant damage to either the male or female reproductive system. Those substances that
can cause birth defects are referred to as teratogens.
The term developmental toxicity refers to adverse effects observed in the embryo, fetus or newborn. In testing, these reproductive effects are usually considered separately from those effects on an adult animal's capacity to successfully mate (fertility) and deliver and nurture offspring (perinatal and postnatal development and maternal function). Developmental toxicity can result from toxicant exposure to either parent before conception or to the mother and her developing embryo-fetus. The three
basic types of developmental toxicity are: Embryolethality which is the failure to conceive, spontaneous abortion or stillbirth; embryotoxicity which is the growth retardation or delayed growth of specific organ systems, and teratogenicity which pertains to irreversible conditions that leave permanent birth defects in live offspring (e.g. cleft palate, missing limbs).
Chemicals can cause developmental toxicity by two mechanisms. They can act directly on cells of the embryo causing cell death or cell damage that leads to abnormal organ development. A chemical might also induce a mutation in a parent’s germ cell that is transmitted to the fertilized ovum. Some mutated fertilized ova develop into abnormal embryos.
Genetic toxicity has also been included in the HCS definition of reproductive toxins. Genetic effects result from damage to DNA and altered genetic expression. This process is known as mutagenesis. The genetic change is referred to as a mutation and the agent causing the change as a mutagen. There are three types of genetic change: Gene mutation is a change in DNA sequence within a gene. Chromosome aberrations are changes in the chromosome structure. Aneuploidy/polyploidy
is an increase or decrease in number of chromosomes
If the mutation occurs in a germ cell (sperm and ova) the effect can be heritable. There is no effect on the exposed person, rather the effect is passed on to future generations. If the mutation occurs in a somatic cell (all body cells except sperm and ova), it can cause altered cell growth (e.g. cancer) or cell death (e.g. teratogenesis) in the exposed person.
Cutaneous Hazard
Cutaneous hazard - irritation, corrosion, allergy, pigment changes, cancer
The HCS definition for cutaneous hazards is "chemicals which affect the dermal layer of the body." This overlaps to a certain extent with the previously described hazards, irritant and corrosive. However, here we are concerned only with effects of toxins on the skin. A variety of skin conditions can arise from exposure to toxic substances. Contact dermatitis or inflammation of the skin can be of two types, irritant dermatitis and allergic contact dermatitis.
The basic inflammatory reaction is the same but the cause and progress of the dermatitis differs. With irritant dermatitis the effect is immediate without prior exposure, whereas the allergic dermatitis requires previous exposure with the development of allergy or sensitization. Contact dermatitis is common in industry and usually consists of redness (erythema), thickening and firmness of skin (induration), flaking (scaling), and blisters (vesiculation). Normally, the contact dermatitis is reversible
if the irritant or allergen is removed.
In contrast, chemical burns can sometimes occur in which immediate necrosis, ulceration, and sloughing of the skin occurs. This injury may be permanent and can leave deep wounds that scar or require transplanted skin to repair the damaged area. Some chemicals can cause irritation by defatting of the skin; for example, commonly used ketones or chlorinated compounds, such as the solvents trichloroethylene, methylene chloride, and gasoline.
Cutaneous hazards may cause skin reactions that are neither irritation or allergic reactions. Oils and halogenated aromatic hydrocarbons can cause acne, mercury and lead can cause increased pigmentation of the skin, hydroquinone can cause decreased pigmentation, and beryllium and chromium can stimulate a granulomatous reaction (having the appearance of small, benign tumors). Skin cancer can be induced by workplace exposure to UV light and arsenic.
Eye Hazard
Eye hazard -- from direct chemical contact with conjunctiva or cornea, or from agent that travels through the bloodstream to the optic nerve and retina.
The HCS definition for eye hazards is "chemicals which affect the eye or visual capacity." The primary toxic effects from direct exposure of chemicals to the eye are conjunctivitis or corneal damage. Conjunctivitis is inflammation of the conjunctiva, the delicate membrane that lines the eyelids and covers the eyeballs. The cornea is the transparent front surface of the eyeball.
Chemicals that accidentally splash onto the face can directly contact either of these eye structures. Acids and strong alkalis (such as lye) may cause severe corneal corrosion and may result in permanent blindness. Organic solvents (such as acetone) and detergents can cause temporary clouding of vision, primarily due to dissolving of fats from the cornea.
Some chemicals can cause toxic effects to the eye even if they do not directly contact the eye. Chemicals that are inhaled or ingested may move to the eye through the blood circulation and produce eye damage. 2-4-Dintrophenol (wood preservative) can cause cataracts after ingestion. The ingestion of thallium salts (in pesticides) and methanol (wood alcohol) has been associated with blindness due to damage to the optic nerve. Retina damage has been associated with exposures to arsenicals and carbon
disulfide.
While animal ocular tests are routinely conducted during the safety testing of new chemicals, detection of damage to the optic nerve and retina are difficult to detect. Unfortunately, this information results from case reports of humans exposed to toxic substances. Irritation and corrosion may be predicted on the basis of the pH of the chemical substance. However, pH has little value in predicting other types of ocular toxicity.
Other Types of Target Organ Hazards
Industrial chemicals can cause toxicity of the cardiovascular system and immune system.
As previously indicated, the HCS does not identify all possible target organ effects due to exposure to toxic agents. Certain chemicals may target one or more specific organs not listed in the HCS. Based on the chemistry of the toxin and how it is metabolized and distributed in the body, virtually any organ or organ system may be at potential risk. Therefore data found in the literature search pertaining to other organs must also be evaluated and documented. Of the other important
health hazards listed in Table 2, effects on the cardiovascular system and immune system are most likely to be reported for industrial chemicals.
Cardiovascular toxicity has been reported for several industrial chemicals. The effects on the heart are primarily interference with cardiac nerve transmissions or damage to the heart musculature (cardiomyopathy). Either type of effect can prevent the heart from contracting (beating) normally so that the blood is not adequately circulated through the body, resulting in multiple organ damage and dysfunction. Some chemicals can also affect the circulatory vessels (veins, arteries and
capillaries). Examples of cardiovascular toxins are ethanol and cobalt (cardiomyopathy); arsenic (arteriosclerosis and vascular lesions); toluene and halogenated alkanes (arrhythmias); and mercury (aortic lesions).
Toxicity to the Immune System can lead to several different effects, depending on which cells are damaged, and whether the toxic effects are due to impairment of the immune system (immunosuppression) or the effects are caused by an altered or enhanced immune system (e.g., allergy/hypersensitivity and autoimmunity). A wide variety of industrial chemicals are known to be immunotoxins, including toluene diisocyanate, formaldehyde, silicone, benzene, heavy metals, halogenated aromatic
hydrocarbons, and insecticides.
DATA DOCUMENTATION
Document the following:
- Chemical inventory
- Procedures used in hazard determination
- Hazardous chemicals list.
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The fourth and final step in the hazard determination process is very important. All the other steps will be wasted if you do not document your findings carefully. If a chemical is found to be hazardous, the findings should be documented in order to assist in preparing labels and MSDSs, and to maintain a record for future reference and updating. In addition, the HCS requires data documentation of the hazard determination as follows:
Chemical manufacturers, importers, or employers evaluating chemicals shall describe in writing the procedures they use to determine the hazards of the chemical they evaluate. The written procedures are to be made available, upon request, to employees, their designated representatives, the Assistant Secretary and the Director [OSHA and NIOSH officials]. The written description may be incorporated into the written hazard communication program required under paragraph (e)
of this section [the HCS].
To meet the HCS requirements, it is recommended that a structured approach to data retrieval and compilation be adopted. This structured approach applies to preparation of MSDSs and labels. Compilations of four types of data are considered essential:
- Initial chemical inventory;
- Description of procedures used for hazard determination;
- Specific data retrieved for each chemical; and
- Hazardous chemicals list
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Chemical Inventory
The chemical inventoryshould consist of all chemicals that are produced, imported, or used by the company. The chemical inventory should be complete and contain, as a minimum, the following:
- chemical name;
- CAS Number;
- common name;
- synonyms;
- product/mixture name (if applicable); and
- percentage in product/mixture (if applicable).
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It is recommended that this chemical inventory be computerized for future sorting, additions, deletions, and status reports.
Description of Procedures Used for Hazard Determination
As indicated previously, the procedures used to determine hazards of chemicals are to be written down and made available upon request to employees as well as OSHA and NIOSH officials. This written description of procedures should be incorporated into the company’s written hazard communication program.
The procedures used for the following hazard determination steps should be described in detail:
- Development of chemical inventory;
- Search strategy and sources used to obtain data on chemicals for which hazard determinations are conducted;
- References retrieved and used to identify each specific physical or health hazard;
- Summary for each retrieved reference that contained relevant data (retrieved computer abstracts can be used);
- Summary of important data that was used for hazard determination; and
- Identification of hazards.
Specific Data Retrieved for Each Chemical
It is recommended that data be organized so as to facilitate the preparation of MSDSs and labels. Listing all the hazard categories and the relevant data obtained for each hazard will also facilitate the gathering of data and document the effectiveness and completeness of the hazard determination process. When data are not located for a specific type of hazard or when a specific hazard would not occur due to the chemical or physical form of the chemical, this should be indicated.
The retrieved data should be listed in the basic format of the MSDS in order to facilitate preparation of MSDSs and labels, as well as allow for future updating as the need arises. It is highly recommended that the data be computerized and archived in a secure location for future use. A commonly used title for hazard data compilations for specific chemicals is hazards profile.
LIST OF DATA TO INCLUDE IN THE HAZARDS PROFILE FOR A CHEMICAL
COMPANY INFORMATION
• Company Name
• Name of Responsible Company Official
• Date Prepared
HAZARDOUS INGREDIENTS/IDENTITY INFORMATION
• Chemical Name
• CAS Number
• Common Name
• Synonyms
• Product/Mixture Name (If Applicable)
• Percentage In Product/Mixture (If Applicable)
PHYSICAL/CHEMICAL CHARACTERISTICS
• Boiling Point
• Freezing Point
• Vapor Pressure (mm Hg.)
• Vapor Density (air = 1)
• Specific Gravity (H2O = 1)
• Melting Point
• Evaporation Rate (Butyl Acetate = 1)
• Solubility in Water
• Appearance and Odor
FLAMMABILITY/EXPLOSIVITY DATA
• Autoignition Temperature
• Flammable Range
• Flash Point (indicate method used)
• Lowest Explosive Limit (LEV)
• Upper Explosive Limit (UEL)
• Extinguishing Media
• Special Fire Fighting Procedures
• Unusual Fire and Explosion Hazards
• Extinguishant
REACTIVITY DATA
• Stability - conditions to avoid
• Incompatibilities - materials to avoid
• Hazardous Decomposition or Byproducts
• Hazardous Polymerization – conditions to avoid
HEALTH HAZARD DATA
• Routes of Entry
• Odor Threshold
• OSHA PEL
• ACGIH TLV
• NIOSH IDLH
• NIOSH REL
• Cancer Classifications:
• OSHA
• NTP
• IARC
SUMMARY -
Health Hazards |
Hazard
Yes/No |
Reference |
| Systemic Effects |
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| Carcinogen |
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| Highly toxic |
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| Toxic |
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| Irritant |
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| Corrosiveon |
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| Sensitizer |
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| Target Organ Effects |
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| Hepatotoxin |
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| Nephrotoxin |
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| Neurotoxins |
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| Blood/hematopoietic toxin |
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| Respiratory toxin |
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| Reproductive toxin |
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| Cutaneous hazard |
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| Eye hazard |
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| Cardiovascular toxin |
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| Immune toxin |
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| Other type of toxicity |
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APPENDICES
A. Glossary of Terms and Definitions
B. Recommended Literature Sources
C. OSHA Toxic and Hazardous Substances
D. OSHA Carcinogens
E. NTP Carcinogens
F. IARC Carcinogens
APPENDIX A
GLOSSARY OF TERMS AND DEFINITIONS
The following glossary presents brief explanations of acronyms and common terms used in this document.
Absorbed Dose. The amount of a substance that actually enters into the body, usually expressed as milligrams of substance per kilogram of body weight (mg/kg).
ACGIH. The American Conference of Governmental Industrial Hygienists is an organization of government and academic professionals engaged in occupational safety and health programs. ACGIH establishes recommended occupational exposure limits for chemical substances and physical agents known as Threshold Limit Values; see TLV.
Acid. Any chemical that undergoes dissociation in water with the formation of hydrogen ions. Acids have a sour taste and may cause severe skin burns. Acids have pH values below 7.
Acute Dose. The amount of a substance administered or received over a very short period of time (minutes or hours), usually within 24 hours.
Acute Toxicity. The toxic effects resulting from a single dose or short exposure to a substance.
Alkali. Also referred to as bases, alkalis have pH values above 7. They may be irritating or corrosive (caustic) to the skin, eyes and mucous membranes, especially at very high pH levels.
Allergic Reaction. An abnormal immunologic response in a person who has become hypersensitive to a specific substance. Some forms of dermatitis and asthma may be caused by allergic reactions to chemicals.
ANSI. The American National Standards Institute is a privately funded, voluntary membership organiza¬tion that identifies industrial and public needs for national consensus standards and coordinates development of such standards.
ASTM. The American Society for Testing and Materials develops voluntary consen¬sus standards for materials, products, systems, and services. ASTM is a resource for sampling and testing methods, information on health and safety aspects of materials, safe performance guidelines, and effects of physical agents, biological agents, and chemicals.
Auto-ignition Temperature. The approximate lowest temperature at which a flammable gas or vapor-air mixture will spontaneously ignite without spark or flame. It is also the temperature to which a closed, or nearly closed container must be heated in order that the flammable liquid, when introduced into the container, will ignite spontaneously or burn.
Benign. Not recurrent or not tending to progress; not cancerous.
Boiling Point-BP. The temperature at which a liquid changes to a vapor state at a given pressure. The boiling point is usually expressed in degrees Fahrenheit at sea level pressure (760 mmHg, or one atmosphere). For mixtures, the in¬itial boiling point or the boiling range may be given. Flammable materials with low boiling points gener¬ally present special fire hazards.
CAS Number. A number assigned to a specific chemical by the Chemical Abstracts Service, an organization operated by the American Chemical Society. CAS Numbers are used internationally to identify specific chemicals or mixtures.
Carcinogenicity. The complex process whereby normal body cells are transformed to cancer cells.
cc. Cubic centimeter is a volume measurement in the metric system that is equal in capacity to one milliliter (ml). One quart is approximately 946 cubic cen¬timeters.
CFR. Code of Federal Regulations. A collection of the regulations that have been promulgated un¬der United States Law.
Chemical Name. The name given to a chemical in the nomenclature system developed by the Inter¬national Union of Pure and Applied Chemistry (IUPAC) or the Chemical Abstracts Service (CAS). The scientific designation of a chemical or a name that will clearly identify the chemical for hazard evaluation purposes.
Chronic Toxicity. Adverse effects result¬ing from repeated doses or exposures to a substance over a relatively prolonged period of time.
Decomposition. Breakdown of a material or sub¬stance (by heat, chemical reaction, electrolysis, decay, or other processes) into parts or elements or simpler compounds.
Dermal. Relating to the skin.
DNA. Deoxyribonucleic acid; the molecules in the nucleus of the cell that contain genetic information.
Dose. The amount of a substance received at one time. Dose is usually expressed as administered or absorbed dose (e.g., milligrams material/kilogram of body weight).
DOT. U.S. Department of Transportation; the Federal agency that regulates transportation of chemicals and other hazardous and non-hazardous substances.
Epidemiology. The branch of science concerned with the study of human disease in specific populations, in order to develop information about the causes of disease and identify preventive measures.
Evaporation Rate. The rate at which a material will vaporize (evaporate) when compared to the known rate of vaporization of a standard material The evaporation rate can be useful in evaluating the health and fire hazards of a material. The designated standard material is usually normal butyl acetate (NBUAC or nBuAc), with a vapori¬zation rate designated as 1.0. Vaporization rates of other solvents or materials are compared to the vaporization rate of the standard material and
then classified as:
FAST - if greater than 3.0. Exam¬ples: Methyl Ethyl Ketone = 3.8, Acetone = 5.6, Hexane = 8.3.
MEDIUM - if 0.8 to 3.0. Exam¬ples: 190 proof (95%) Ethyl Alcohol = 1.4, VM&P Naphtha = 1.4, MIBK = 1.6.
SLOW - if less than 0.8. Exam¬ples: Xylene = 0.6, Isobutyl Alcohol = 0.6, Normal Butyl Alcohol = 0.4, Water = 0.3, Mineral Spirits = 0.1.
Explosive Limits. The range of concentration of a flammable gas or vapor (percent by volume in air) in which explosion can occur if an ignition source is present.
Flammable. A material which is easily ignited and burns.
Flammable Aerosol. An aerosol that, when tested by the method described in 16 CFR 1500.45 yields a flame projection exceeding 18 inches at full valve opening, or a flashback (a flame extending back to the valve) at any degree of valve opening.
Flashback. Occurs when flame from a torch burns back into the tip, the torch, or the hose. It is often accompanied by a hissing or squealing sound with a smoky or sharp-pointed flame.
Flashpoint. The minimum temperature at which a liquid gives off a vapor in sufficient concentration to form an ignitable mixture in air or oxygen. The HCS specifies that the testing should be conducted by one of the following methods:
(a) Tagliabue Closed Tester (see American Na¬tional Standard Method of Test for Flash Point by Tag Closed Tester, Z11.24 1979 [ASTM D 56-79]).
(b) Pensky-Martens Closed Tester (see American National Standard Method of Test for Flash Point by Pensky-Martens Closed Tester, Z11.7-1979 ASTM D93-79]).
(c) Setaflash Closed Tester (see American Na¬tional Standard Method of Test for Flash Point by Setaflash Closed Tester [ASTM D 3278-78]).
Genetic. Pertaining to or carried by genes; hereditary.
Hazard. The inherent capacity of a substance to cause an adverse effect.
IARC. International Agency for Research on Cancer, a component of the World Health Organization, located in Lyon, France.
Ignitable. A solid, liquid or compressed gas which is capable of being set afire.
In Vitro. Outside a living organism (e.g., in a test tube).
Inhalation. Breathing in of a substance in the form of a gas, vapor, fume, mist, or dust.
Latency Period. The period of time between an exposure and onset of toxicity.
LC50. Lethal Concentration 50%. The calculated concentration at which 50% of the population is expected to die following a specific period of exposure. The LC50 can be expressed in several manners; for example, as parts of material per million parts of air, by volume (ppm), or as milligrams of material per cubic meter of air (mg/m3).
LD50. Lethal Dose 50%. The estimated single dose at which 50% of the population is expected to die. The LD50 dose is usually expressed as milligrams or grams of material per kilogram of animal body weight (mg/kg or g/kg). The material may be administered orally or applied to the skin.
LEL or LFL. Lower explosive limit or lower flammable limit; the lowest concentration of a vapor or gas (lowest percentage of the substance in air) that will produce a flash or fire when an ignition source (e.g., heat, arc, or flame) is present. At concentrations lower than the LEL, the mixture is too "lean" to burn; also see UEL.
m3. Cubic meter; a metric measure of volume, approximately 35.3 cubic feet or 1.3 cubic yards.
Malignant Tumor. A tumor that can invade surrounding tissues or metastasize to distant sites resulting in life-threatening consequences.
Melting Point. The temperature at which a solid substance changes to a liquid state.
Metabolism. The conversion of a chemical from one form to another within the body; also referred to as biotransformation.
Metabolite. A chemical produced during metabolism.
mg/kg. Milligrams of substance per kilogram of body weight, commonly used as an expression of toxicological dose (e.g., 15 mg/kg).
mg/m3. Milligrams per cubic meter; a unit for measuring concentrations of particulates or gases in the air (a weight per unit volume). For example, 20 mg/m3.
milligram (mg). The most commonly used unit of measure in medicine and toxicity consisting of one thousandth of a gram (1x10-3 g).
Mixture. Any combination of two or more substances, if the combination is not, in whole or part, the result of chemical reaction.
ml. Milliliter; a metric unit of volume. There are 1,000 milliliters in one liter. 1 teaspoon = 5 milliliters.
Mutagen. A substance or agent capable of altering the genetic material in a living cell (mutation).
NFPA. The National Fire Protection Association is an international membership organization which promotes fire protection and prevention and establishes safeguards against loss of life and property by fire.
NIOSH. The National Institute for Occupational Safety and Health is a part of the Centers for Disease Control and Prevention, U.S. Public Health Service, U.S. Department of Health and Human Services.
NTP. The National Toxicology Program is a component of the U.S. Public Health Service. The NTP publishes the Annual Report on Carcinogens.
Odor Threshold. The lowest concentration of a substance in air that can be detected by smell.
Oxidation. A change in a chemical characterized by the loss of electrons. In a literal sense, oxidation is a reaction in which a substance combines with oxygen.
PEL. Permissible exposure limit; a legally enforceable occupational exposure limit established by OSHA.
ppm. Parts per million; the proportion (by volume) of a gas or vapor per million parts of air; also the concentration of a chemical in a liquid or solid form.
Reactivity. The tendency of a substance to undergo a chemical change with the release of energy. Undesirable effects (pressure build-up, temperature increase, formation of noxious, toxic or corrosive by-products) may occur because of a reaction to heating, burning, direct contact with other materials or other conditions when in use or in storage.
Risk. The probability that an adverse effect will occur.
Solubility. The ability of a substance to be dissolved in a solvent. Solubility is expressed according to the solvent (e.g., solubility in water, solubility in acetone, etc.).
STEL. Short-Term Exposure Limit (ACGIH terminology); see TLV.
Synonym. Another name or names by which a material is known. Methyl alcohol, fo |