ASTM proposes standard for rubber allergens

West Conshohocken, Pennsylvania - The American Standards body, ASTM, has proposed a new standard to test for potent allergens in rubber. WK16334, Test Method for the Immunological Measurement of Four Principal Allergenic Protein (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products, is being developed by Subcommittee D11.40 on Consumer Rubber Products, part of ASTM International Committee D11 on Rubber.

According to Timo Palosuo and Robert Hamilton, co-chairs of Task Group D11.40.08 on Immunoenzymetric Assay (IEMA), at least 13 Hevea brasiliensis (Hev b) natural rubber latex proteins have been identified as strong allergens that can induce allergic reactions in predisposed humans. Healthcare workers who use many natural rubber latex products (such as gloves) and children who need to have multiple surgeries (which require contact with rubber gloves and medical devices during procedures) are especially susceptible to allergic reactions caused by rubber proteins.

“Prior to this newly proposed standard, there has been no standardised assay method for measuring Hevea brasiliensis allergenic protein that is extractable from a rubber containing product,” says Palosuo, professor emeritus, National Public Health Institute, Helsinki, Finland. “This proposed standard provides the first well-documented assays for measuring four of the principal 13 known Hev b allergens.”

“The primary application of the assay is in the evaluation of extracts of products known or supposed to contain natural rubber latex,” says Hamilton, professor of medicine and pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland. “The four assays will permit an investigator to qualitatively (present or absent) and quantitatively (ng/ml) test the level of these principal allergenic proteins that are known to elicit sensitization and symptom induction in sensitized children and adults.”

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Press release from ASTM