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Oracle Process Manufacturing Regulatory Management User's Guide
Release 12.1
Part Number E13693-04
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American Conference of Governmental Industrial Hygienists. US organization that establishes occupational exposure limits for substances.
Action Phrase
Action phrases replace conflicting phrases with the same phrase type and hierarchy. For example, the phrases "Wash with soap and water" and "Do not wash with soap under any circumstances" can be replaced with a conflict action phrase such as "Rinse with water" that prints on documents when the conflict occurs.
European regulations for the international transport of dangerous goods via inland waterways in the European states.
European regulations for the international transport of dangerous goods via road in the European states.
American National Standards Institute.
Auto Ignition Point
The temperature that a substance spontaneously ignites at.
Boiling Range/Point
The temperature or range of temperatures that a liquid turns to vapor at.
A substance that causes cancer.
Chemical Abstracts Service. Catalogs chemical substances.
CAS Registry Number (CASRN, RN)
The Chemical Abstracts Service numbers assigned to items. A unique accession number assigned by the Chemical Abstracts Service, a division of the American Chemical Society. Other than being guaranteed unique to a given compound, this number has no particular meaning. A CAS Registry Number includes up to 9 digits that are separated into 3 groups by hyphens. The first part of the number, starting from the left, has up to 6 digits; the second part has 2 digits. The final part consists of a single check digit.
Canadian Environmental Protection Act. A Canadian environmental law that requires the domestic substances list (DSL) and the non-domestic substances list (NDSL).
Comprehensive Environmental Response, Compensation, and Liability Act. A US EPA law.
Chemical Transportation Emergency Center. Provides 24-hour transportation emergency information to registered companies.
Conference of North Eastern Governors. Passed laws in several states that regulate the amount of lead, mercury, cadmium, and hexavalent chromium in packaging materials.
A substance that changes or destroys living tissue.
Control of Substances Hazardous to Health. UK legislation.
Dangerous Preparation Directive (1999/45/EC)
A preparation is classed as dangerous and is therefore subject to the provisions of Directive 1999/45/EC if it:
Dangerous Substance Directive (67/548/EEC)
The Dangerous Substance Directive (67/548/EEC) was introduced in 1967. It lists common provisions on the classification of dangerous substances. This includes the placement of a substance into one or several defined classes of danger characterized the type and severity of the adverse effects that the substance can cause. The directive also advises the packaging of dangerous substances, because adequate packaging protects from the known dangers of a substance. Labeling of dangerous substances is provided, because the label on the packaging informs about the nature of the dangers of the substance inside and appropriate safety measures to apply during handling and use.
The mass per unit volume of a material.
Disclosure Code
Disclosure codes are groupings of legislative reporting levels linked to legislative or recipient requirements and their respective recipients.
Department of Transportation. A US government agency that regulates the transportation of hazardous materials.
Domestic Substances List. A Canadian list of items manufactured in or imported to Canada. The DSL is regulated by the CEPA.
Electronic Records.
European Economic Community.
In UK COSHH regulations, Guidance Note EH40 lists occupational exposure limits for substances in air.
Environment, Health, and Safety Committee.
European Inventory of Existing Chemical Substances. An EEC list of known chemical substances tracked by EINECS and CAS numbers.
The number assigned to the items on the EINECS list.
European List of Notified Chemical Substances. Supplements the EINECS list.
The number assigned to the items in the ELINCS list.
Environmental Protection Agency. A US government agency that regulates and enforces environmental laws.
ERG Number
Emergency Response Guidebook Number. The item reference number in the ERG.
A substance that releases pressure, gas, and heat suddenly when subjected to certain conditions.
Explosive Limit
The concentration range in percent of a gas or vapor that can explode.
Exposure Authority
Exposure authorities are companies or legislative bodies that determine the item exposure limit reporting requirements.
Exposure Type
Exposure types are the kinds of exposures that must be reported such as long-term, short-term, minimum, and maximum.
A substance that produces a flame when subjected to certain conditions.
Flash Point
The minimum temperature that a liquid is ignitable at.
Freezing Point
The temperature that a liquid begins to form crystals or solidify at.
The dangerous properties of a substance.
Hazard Classification
Hazard classifications are required when shipping chemicals within Europe and when other countries ship products to Europe. For example, an item that causes severe burns to humans and kills aquatic life if disposed of in rivers would have the European hazard classifications of Very Corrosive and Dangerous to the Environment.
Hazard Groups
Hazard groups describe the types of dangers that European hazard classifications have. For example, an item with the European hazard classifications of Very Corrosive and Dangerous to the Environment is included in the Health-Toxic and Environmental hazard classification groups.
Hazardous Material Information System. A US system of rating the health, flammability, and reactivity of substance hazards for workers. Substances in each hazard category are rated from 0-4.
International Agency for Research on Cancer. The IARC ranks actual and potential carcinogens.
IATA Class
International Air Transport Association classification.
International Civil Aviation Organization.
IMDG Class
International Maritime Dangerous Goods classification.
A substance that inflames living tissue, but does not irreversibly change or destroy it.
Item Groups
Item groups group items that are in the same chemical family or share the same properties such as organic acids. You can consolidate similar ingredients in a product into one item group on a document.
Kemmler Code
A European hazard identification number that is required on vehicles transporting dangerous goods in Europe.
Lethal Concentration Fifty. The calculated concentration of a substance in air that kills 50% of the test group with a single exposure.
Lethal Concentration Low. The lowest concentration of a substance in air that has caused death in humans or animals (except LC50.) The reported concentrations can be entered for periods of exposure less than (acute) or greater than (sub-acute and chronic) 24 hours.
Lethal Dose Fifty. The calculated amount of a substance that kills 50% of the test group with a single dose.
Lethal Dose Low. The lowest dose of a substance introduced by a route other than inhalation, over a period of time, in one or more portions, that has caused death in humans or animals (except LD50).
Long-term exposure limit.
Maximum exposure limit.
Melting Point
The temperature that a solid begins to liquefy at.
MFAG Table Number
The Medical First Aid Guide reference numbers for items.
MITI Number
Japanese Ministry of International Trade and Industry number for the item.
Material Safety Data Sheets are documents that provide information about hazardous materials. OSHA regulation 29 CFR Part 1910.2000, European Directive 91/155/EEC, and Canadian Regulations exist for MSDS documents.
A substance that alters the genetic makeup of a cell.
Non-domestic Substances List. Lists items that are not part of the Canadian market and are considered non-domestic. The list is based on TSCA.
A substance that causes benign or malignant growths.
National Fire Prevention Association. Promotes fire protection and prevention.
National Pollution Regulatory Initiative. The NPRI list provides Canadian Regulatory legislation.
Odor Threshold
The lowest concentration of a substance detectable by smell.
Occupational Safety and Health Administration Hazard Communication Standard (HCS), Subpart Z, Toxic and Hazardous Substances (29 CFR 1910.1200)
In order to ensure chemical safety in the workplace, information must be available about the identities and hazards of the chemicals. The OSHA HCS, Subpart Z, Toxic and Hazardous Substances (29 CFR 1910.1200), requires the development and dissemination of information. Chemical manufacturers and importers are required to: Employers with hazardous chemicals in their workplaces must have labels and MSDSs for their exposed workers, and they must train workers to handle toxic and hazardous appropriately.
A substance that causes combustion in other materials.
Partition Coefficient
The distribution of a substance or mixture between two phases, such as between a liquid and a gas.
Permissible Exposure Limit. A workplace concentration exposure limit.
The concentration of hydrogen in a solution. The number, ranging from 0 - 14 describes the degree of acidity (0 - 7) or alkalinity (7 - 14) of the solution.
Phrase Code
Phrase codes hold information about a product's dangers and qualities. For example, "Wash with Soap and Water."
PIN Number
Product Identification Number. A Canadian identification number that typically uses UN or NA numbers.
A chemical reaction that causes molecules to bond and form larger molecules. Polymerization is dangerous when the reaction releases large amounts of energy.
Product Class
Product classes are groupings of products with similar requirements or properties. For example, Liquids.
Property ID
Property IDs identify the different properties that are assigned to a label. For example, the boiling point label is associated with a temperature property ID. In addition, properties are set up on the Properties window and displayed on the window associated with each label on the Regulatory Information navigator.
Property Type
Property types identify the kinds of a property assigned to a label. For example, a property ID such as temperature can have a type of flag, numeric, alphanumeric, date, or phrase.
Property Value
Property values identify the valid values assigned to properties assigned the type flag. For example, the temperature property ID can have a list of valid temperature values such as Celsius, Fahrenheit, and Kelvin. The actual temperature is entered on the Regulatory Information navigator, on the property window associated with label.
Proposition 65
The Safe Drinking Water and Toxic Enforcement Act of 1986. Proposition 65 regulates warning requirements on materials that the US state of California has designated to be known carcinogens and/or teratogens.
European regulations for the international transport of dangerous goods via rail in the European states.
Right-to-Know Act
A law requiring companies to supply product composition information on labels or documents or both. This law is also known as SARA Title III and is administered by the Environmental Protection Agency.
Right-to-Know Labels
The Right-to-Know Act requires companies to disclose the contents of materials by labeling containers with the ingredients.
A risk is the possibility that a substance's hazardous properties could cause harm to people or the environment.
Risk Phrase
Risk phrases supply information about the hazards of a chemical during normal use. Both European hazard classifications and risk phrases are required by EEC directives for chemical transport in Europe.
Safety Data Sheet Directive (91/155/EEC)
Provides an outline of information to be included on an MSDS for Europe.
Safety Phrase
Safety phrases supply advice on safety precautions that are appropriate when using the substance.
Superfund Amendments and Reauthorization Act of 1986. SARA is a US regulation concerning emergency response plans and the Right-to-Know Act. SARA is administered by the Environmental Protection Agency.
SARA 313
The SARA 313 Reportables List is a yearly report of emissions to the air, land, and water of materials designated by SARA Title III, Section 313. Statements about these materials must be reported on MSDSs.
Short-term Exposure Limit. The maximum concentration of a material that you can be exposed for 15 minutes.
Toxic Concentration Low. The lowest concentration of a material in air that humans or animals have been exposed for any given period of time, that has produced any toxic effect in humans, or produced a carcinogenic, neoplastigenic, or teratogenic effect in animals or humans.
Transportation of Dangerous Goods Act. Canadian legislation.
Toxic Dose Low. The lowest dose of a material introduced by any route, other than inhalation, over any given period of time, and reported to produce any toxic effect in humans or to produce carcinogenic, neoplastigenic, or teratogenic effects in animals or humans.
A substance that causes birth defects.
Threshold Limit Value. The maximum concentration of a material that a worker can be exposed to during an eight hour day.
Ceiling Threshold Limit Value. The maximum concentration of a material that a worker can be exposed to under any conditions.
A substance that has a particular lethal dose.
Toxic Dose
The amount time and concentration of a substance that you can be exposed to under specific conditions.
Toxic Effects
Toxic effects are the known hazardous effects of a chemical substance, such as allergic or carcinogenic effects.
Toxic Substances Control Act. A US law regulated by the Environmental Protection Agency (EPA) to control risks to human health and the environment. The EPA issues a list of substances called the TSCA Inventory.
UN Number
United Nations number. Assigned to hazardous materials to identify them during shipping and transportation.
Vapor Density
The relative weight of a vapor compared to air.
Vapor Pressure
The pressure a vapor exerts above its own liquid in a closed vessel.
Workplace Hazardous Material Information System
The Workplace Hazardous Materials Information System is Canada's hazard communication standard. The key elements of the system are cautionary labeling of containers of WHMIS "controlled products", the provision of material safety data sheets (MSDSs), and worker education programs.