• This is the second blog in a three-part series. You can read Part 1 here.
• Chemicals of concern are omnipresent in industry.
• GHS hasn’t led to as much “harmonious” practices as expected.
• Substance test data is by far the largest set of data that is considered when a hazard evaluation is completed.
• There is other information to consider from mandatory, advisory and raw material lists as well as product data.
This is the second part of a three-part series regarding chemicals of concern. In Part 1, we discussed the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) framework, the differing adoptions per jurisdiction and the impact this has had on classifying chemicals of concern.
In Part 2, we will discuss the different data types used to evaluate chemicals of concern: substance data, mandatory classification list data, advisory agency classification/list data, raw material data and product data. Knowing what these data types are as well as what should be considered when using them is critical to determining if a material is a chemical of concern of not. So, let’s jump in!
Start With Substance Data
Substance test data is by far the largest set of data that is considered when a hazard evaluation is completed. This data is considered foundational to an overall hazard evaluation. Whether your chemical of concern is a pure substance or a mixture, in most cases, substance data sets the stage for the possible or potential hazards of your product. Substance test data can include published studies such as Lethal Concentration 50 (LC50) and Lethal Dose 50 (LD50) test results for acute toxicity, irritation, sensitization or reproductive test results.
It can also include data from alternative test methods, predicted or modelling data from quantitative structure-activity relationships (QSARs) as well as data from epidemiological studies or information from direct human exposure. This data is vast and complex. There is no one source to obtain all data for a given substance—but boy wouldn’t that be nice!
Substance test data can be found via various sources such as Registry of Toxic Effects of Chemical Substances (RTECS), European Chemicals Agency (ECHA) registration dossiers, scientific literature, eCHEM Portal and many, many others. It is important to keep in mind that each source has its own specific purpose and limitations that are imperative to understand to ensure you are using the data appropriately when performing a hazard evaluation. For example, data from the ECHA registration dossiers is entered by its users and this data is not reviewed upon entry. Therefore, while you can find some useful data via this source, there also are potential errors in that data. All in all, this is high value data, and it is the basis for determining if a substance is a chemical of concern. It is also the foundation for the next type of data we will be discussing, which is mandatory classification list data.
Mandatory List Data
Mandatory classification list data are lists that authorities have created to provide a common classification for specifically listed substances. These include lists such as the European Union classification, labelling and packaging of substances and mixtures (CLP) Annex VI, South Korea’s GHS Classification for Toxic Chemicals from the National Institute of Environmental Research (NIER), and China’s Catalog of Hazardous Chemicals.
These countries maintain their own lists. Those classifying for these lists face the same challenge as anyone in this industry does when trying to complete a substance hazard evaluation. As we have already discussed, there is a plethora of substance data out there and, depending on which test(s) a particular authority decided to use for their classification, they may have come up with a different result than another regulatory body. Therefore, there may not be 100% consistency between the countries in how they have classified the same substances. Using these lists is not as simple as taking the classification and using it as part of your hazard evaluation. There are often rules and other notations that you need to be aware of in order to use them appropriately. This data type has a very high value specifically if you are assessing a chemical in one of these countries that has a published list.
It is also important to note that not all classification lists issued by countries are “mandatory.” It is critical that, as a Safety Data Sheet (SDS) author, you know which ones are required and which ones are not. This brings us to the next type of data, which is advisory agency classifications.
Advisory List Data
This data type includes data compiled by the American Conference of Governmental Industrial Hygienists (ACGIH), International Agency for Research on Cancer (IARC) and nonmandatory classification lists such as Australia’s GHS hazardous chemical information list. Some of these lists may have more reliable data than others. It is important to understand how the lists are compiled so that you can evaluate how they should be used in your overall hazard evaluation process. As noted earlier, some of these lists include nonmandatory classification lists. They are often compilations of other countries’ lists and may or may not be maintained diligently over time. Both the IARC or ACGIH, for example, provide information that can be helpful to you when classifying your substances. Overall the value of this data type is highly dependent on the source that you are using and purpose for using it.
Raw Material Data
Raw material data is next data type we will be discussing. This is information from the manufacturer, distributor or supplier of the raw materials that are part of the products being evaluated. At a minimum, ingredient information should be used as a first step for determining classifications for mixtures. Many times, supplier documents (SDSs) have a ton of data on them such as ingredient classifications, material classifications, health hazard and ecotoxicity test data for both the raw material and ingredients and all these data points could be used in an evaluation for your product.
When deciding on how to use this data type, you have two choices: You could either choose to use the raw material data or choose not to. Which one you ultimately choose boils down to a business decision based on multiple factors including, but not limited to, the types of products you have, your industry and overall corporate strategies. Some companies rely only on raw material SDS information to develop their product classifications.
They make this decision based on various factors, but anyone choosing this business decision needs to keep in mind that they are ultimately the one responsible for the classifications and information that is included on their product SDSs. From a regulatory perspective, raw material information should at least be reviewed during the hazard evaluation process. My recommendation would be that raw material information also be used in conjunction with substance data prior to being included in an evaluation to fully protect your company’s interests and ensure that the SDS and hazard information you issue adequately protects workers when using that product.
Practically speaking, however, as the number of SDSs that a company must author grows evaluating all data (raw material data and substance data) becomes exponentially more difficult. Therefore, the second choice is choosing to not consider raw material data at all in your overall product evaluation. In terms of resources and cost, paying for access to more robust, reliable substance data sources may be the better business decision for companies that have to author large volumes of SDSs. That’s because of resource limitations as well as process complexities and potential risk involved with using information from suppliers, which might not be of the highest quality or even up to date.
Ultimately the usage of raw material data is a business decision that will depend on a company’s products and many other factors. For example, for a company with products that contain ingredients that are common chemicals with a lot of substance data (toluene, acetone, etc.), the business decision may be to use substance data and not consider raw material SDSs. Compared to a company with products that mostly contain new novel chemistries that have no substance data, these companies would likely lean more on supplier information to determine their product classifications because the raw material data might be all that is available. Not all raw material SDSs are complete or compliant, and how they are used is ultimately a business decision in which the type of products impact the overall value of this data type.
Beyond raw material data, some companies also may have data for their products or finished goods, which brings us to our final data type: product data. A product can be a substance or a mixture. For this data type, it is important to know that there is no requirement to test a product to determine the hazards of a material under both the United Nations’ GHS and many of the regulatory bodies that have adopted GHS. Anytime product data is available, it takes priority when evaluating the hazards.
Commonly, there will be test data for physical hazards because this testing is less costly and also important, if not critical, for transportation assessments. Generating test data for some of the health hazards can be expensive and take an extensive amount of time. So, the combination of not having a requirement to test and the high cost of testing makes product-level test data for health hazards rare. Having personally authored or overseen the authoring of thousands of SDSs, I can count on one hand the number of times in 10 years that I have had product test data for health hazards to use to evaluate the hazards.
Product data can also include information about the hazards (or lack thereof) of a product in use. This could be information collected from customers using this product who may have reported adverse effects. It could also be knowledge of a product in use. A good example of this is where an ingredient that may pose a hazard as a dust is inextricably bound in the product and would never be released. Therefore, that ingredient would not impact the overall product-level classification even though it may be present in the product above a cut-off percentage. This data type is highly valued because it can drive more definitive classifications than using the other data types and their associated cutoffs to evaluate the hazards of a product.
As you can see, there are many data types, and knowing what to consider when evaluating these various data types is highly complex and dependent on multiple variables. Keep watching for our final blog post in this series where we will discuss best practices for not only using the individual data types but also important best practices related to using the data in the hazard evaluation process.