2024-04-05 10:06:44
A substance used as an intermediate to make rubber
Diphenylguanidine (DPG) is a synthetic intermediate substance used mainly in the manufacture of rubber as a vulcanization accelerator, which makes the rubber more resistant to pressure and stress. Residues of this substance can be found in rubber items such as flooring, shoes, toys and tires. It has also been detected in drinking water and household dust. Its presence is reported in the aquatic environment and appears to be associated with tire abrasion releasing particles.
Strengthened classifications to protect human health
Diphenylguanidine currently has a harmonized classification at European level within the framework of the CLP regulation. During the DPG evaluation process under the REACH regulation, ANSES concluded that it was necessary to revise this harmonized classification. The Agency has notably identified that the level of evidence concerning the reprotoxic nature of the substance justifies an increase in its classification, following the updating of the evaluation of the various effects of the substance in the light of the latest available data.
Thus, the Agency proposes an evolution of the classifications for human health, in particular for acute skin and eye effects as well as reproduction and development. In several studies, DPG has indeed been shown to be toxic by ingestion and corrosive to the eyes in rodents. In addition, numerous human data have demonstrated cases of allergy to DPG. Most of these data are retrospective studies conducted in occupational settings that investigated DPG sensitization in patients for whom there was a presumption of allergy to rubber gloves. Finally, studies show effects of DPG on fertility and development in rats and mice and neurological disorders in rats.
“A classification as a category 1B reprotoxic substance will have direct repercussions on the protection of workers’ health due to the obligations to implement reinforced preventive measures provided for in the labor code for carcinogenic, mutagenic and reprotoxic substances .” explains Alice Mateus, who evaluated the DPG. ANSES is also continuing work on the substance as part of an analysis of the best regulatory management option (RMOA). This involves verifying the need for additional regulatory framework measures, taking into account in particular a reinforced classification.
Finally, on the environmental side, ANSES proposes a less strict classification. Based on the most recent and reliable biodegradation study, DPG is indeed considered to be rapidly biodegradable. It has a low bioaccumulation potential. Studies show chronic toxicity to aquatic organisms, with algae being the most sensitive species tested.
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