By Robert Kapp, Ph.D.
Safety Data Sheets (SDSs) (formerly known as Material Data Sheets (MSDSs) contain basic information about a chemical or product needed to insure the safety and health of the user at all stages of its manufacture, storage, use, and disposal.
Interestingly, SDSs have a long and involved history, extending back into time – ultimately resulting in the present-day format. There are records indicating that MSDS-like documents were used 4000 years ago to describe pharmaceutical use in Egypt. A thousand year later, the Greeks recorded not only their own observations, but also some of their early experimental work on similar documents. Skipping ahead another millennium, chemical data sheets were continuously being developed by chemists at avante garde chemical companies as a way of transmitting various data to fellow chemists: melting/freezing/flash points, viscosity, density. As the industry became more enlightened in the last 100 years or so, the chemists began adding additional items, such as reactions and fire hazards. While health/safety and toxicological data had been developing over the past few 1000 years, it was only recently included on these data sheets as the next logical step in an all-inclusive document.
The US Federal Government got involved in the mid-1960s and developed its original Form LSB-00S-4 to meet the needs of maritime workers, added safety and hazard information for the first time to a chemical safety sheet. It was published and became law on August 23, 1968 in 33 FR 12008 as amendments to 29 CFR parts 1501, 1502 and 1503. Over the ensuing few years, there was pressure on Congress to extend benefits of the Longshoreman’s Act, plus additional safety and health coverages, to all of the nation’s industrial workers. With the passage of Public Law 91-596, on December 29, 1970, OSHA was established within the Department of Labor.
Initially, the formatting for these MSDS’s was fluid and varied considerably from company to company and from country to country. The EU standardized the format into what is now the 16-section document. Nevertheless, the quality, type of information and specifics of the MSDSs remained chaotic and in the minds of regulators, need some consistency. There was an effort to coordinate these vastly different documents by the US Government: The Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), was revised in 2012, requiring that the chemical manufacturer, distributor, or importer provide Safety Data Sheets (SDSs) (formerly MSDSs or Material Safety Data Sheets) for each hazardous chemical to downstream users to communicate information on these hazards.
The information contained in the SDS is largely the same as the familiar MSDS, except now the SDSs are required to be presented in a consistent user-friendly, 16-section format. When one creates an SDS, he/she must be aware that the proper labeling and warnings are included for the area (country) the product will be sold – the place that regulates the product.
Sections 1 through 8 contain general information about the chemical, identification, hazards, composition, safe handling practices, and emergency control measures (e.g., firefighting). This information should be helpful to those that need to get the information quickly. Sections 9 through 11 and 16 contain other technical and scientific information, such as physical and chemical properties, stability and reactivity information, toxicological information, exposure control information, and other information including the date of preparation or last revision. The SDS must also state that no applicable information was found when the preparer does not find relevant information for any required element.
The basic toxicological information is placed methodically in Section 11. While the specific format is not set, the acute data is a generally good place to start. Toxicological data such as the oral and dermal LD50s (Dose at which 50% of the animals exposed would be expected to succumb – this is a calculated formulaic number from a limited number of animals) as well as the inhalation LC50s (Concentration of a chemical at which 50% of the animals exposed would be expected to succumb). Basic information on skin, mucous membrane, respiratory and eye irritation as well as any repeated dose information would also be inserted in this section. Any cancer listings from IARC, EPA, NTP, ACGIH, NIOSH or OSHA would be included here. Any repeated dose studies that generate the no observed adverse effect level (NOAEL) should be briefly included here. Some companies insist on a toxicological profile of the chemical in this section, while others put minimal information.
There are other sections which will depend upon the toxicology section. For instance, Section 3 is the Hazard Identification and usually deals with the safe handling of the material by the user. This also includes things other than toxicity (e.g. flammability, vapor, etc.) but it is the application of the toxicological data to direct how the user must handle the product. If there are serious issues in handling the product, this has to be pointed out here. Sometimes potential health effects are detailed in this section. If this is global/EU, then those warning pictograms go in this section.
Section 4 is first aid. There are stock phrases that go in here based upon the toxicological profile of the material. Section 5 is Fire Fighting measures and can also relate back to the toxicology section if there’s some serious chemical reactions with the product.
Section 12 is ecological information. This is very important for EU. They put more emphasis on this than we have historically here in the US. The EU regulators want to know the potential ecotoxicity to fish, daphnia, algae and if the product biodegrades and/or bio-accumulates which can produce long-term harm to the environment.
The relevant regulatory information including exemptions, what agency takes precedence, rules to follow in the country that product is in, Toxic Substances Control Act (TSCA) – 1976 Public Law 94-469) listing, etc., should be in Section 15.
To summarize, many companies put a considerable amount of information on their SDSs while others – not so much. As a rule of thumb, the data should be as complete as possible with what is at hand with toxicological statements evaluated by a certified toxicologist. One should never speculate or overstate the effect of the product. As in all things scientific – be truthful and accurate.
Posted in Drugs, EASeNews, Issue of the Month and tagged Robert Kapp.