Safety Data Sheet (SDS) Health Hazard Determination for Mixtures
(According to OSHA)
Health hazard determination for a product consisting of just one well-established ingredient is generally quite straight forward, but it still requires good knowledge of target market and local regulations. There is a lot of health hazard information publicly available for a large number of ingredients including SDSs issued by different manufacturers and suppliers. On the other hand, writing SDS for a mixture, which consists of multiple ingredients could be quite challenging.
In general, SDS authors would follow the following process for estimation of health hazards of complex mixtures (in order):
1) It is always recommended to test the whole mixture for as many potential hazards as possible. However, such testing is time consuming and often not affordable for most businesses. It is also not required to conduct such tests by current regulation.
2) In the absence of reliable test data for the whole mixture, SDS writers should look for available data on similar mixtures and use so called bridging principles as outlined in section A.0.5 of OSHA Appendix A to §1910.1200.
3) In case of no data available for the whole or similar mixtures, there are certain approved methods available for estimation of health hazards as outlined in OSHA Appendix A to §1910.1200.
In many cases the estimated hazards may be exaggerated, which could influence the acceptance of the product in the market. Thus, it may be worthwhile to conduct appropriate testing of the product in certified laboratories, which could potentially result in safer hazard category classification on SDS. However, classification for Carcinogenicity, Germ Cell Mutagenicity, and Reproductive Toxicity is typically based on ingredient properties (with exception of certain case-by-case considerations of the whole mixture test results). In some instances the manufacturers may overestimate the concentrations of hazardous ingredients in their product (due to chemical reactions, using proprietary raw materials, etc.) and laboratory determination of exact composition may give concentration values below certain cut-off limits, which may also result in safer classification of the whole product on SDS.