The IP 346 test standard and classification as a carcinogen

A recent discussion in the LinkedIn group Globally Harmonized System of classification, labeling and packaging of chemicals (GHS) concerned the test standard IP 346 and classification as a carcinogen for certain petroleum products. IP 346 refers to the “Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions – Dimethyl sulphoxide extraction refractive index method.” It is therefore a test for polycyclic aromatics (PCAs), which are carcinogens.

In the SDSs of some petroleum products, it is not uncommon to see statements regarding the percentage of DMSO extractables as determined by IP 346. A value lesser than 3% is used as supporting data for not classifying the petroleum product as a carcinogen. This allowance is made in Annex VI of the EU CLP, which contains the harmonised classification and labelling for certain hazardous substances. In the absence of test data, the harmonised classification should be used. However, Note L in the annex states that:

“The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346 ‘Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method’, Institute of Petroleum, London. This note applies only to certain complex oil-derived substances in Part 3.”

Thus, in order to avoid classification as a carcinogen, it is common for suppliers and manufacturers of petroleum products listed in Part 3 to test their products with the IP 346 standard. While the use of IP 346 is not directly addressed in other jurisdictions, it should meet the criteria for an acceptable test method under GHS, with the EU CLP legislation being evidence for its rigour. In short, the IP 346 test standard may be used to provide supporting data in determining the carcinogenicity classification of a product under GHS.

 

 

 

 

 

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