Chemical name: 1,2-dibromoethane Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All uses are prohibited. Pesticide use or uses that remain allowed: None The final regulatory action was based on a risk or hazard evaluation: No Summary of the final regulatory action: The Annex I of the Ordinance on the plant protection products (OPPP) enumerates all active substances officially recognized that can be used in plant protection products. 1,2-dibromoethane is not listed in Annex I as active substance and is thus banned in plant protection products. Moreover, this substance is associated with reproductive, carcinogenic and genotoxic effects (see 1.8.2) and is classified as a category 2 carcinogen in Switzerland. According to Annex 1.10 of the Ordinance on the Reduction of Risks linked to Chemical products (ORRChem), the substances classified as carcinogens mutagens or toxic to reproduction are forbidden to the public. This ban does not apply to medicines, paints for artists and fuels. The packaging of substances and preparations considered to be carcinogenic, mutagenic and toxic for reproduction must bear the inscription: Restricted to professional users The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: 1-2-Dibromoethane has induced an increased incidence of tumours at several sites in all carcinogenicity bioassays identified in which rats or mice were exposed to the compound by gavages, ingestion in drinking-water, dermal application and inhalation, although many of these studies were limited by high early mortality, limited histopathological examination, small group sizes or use of only one exposure level. The substance acted as an initiator of liver foci in an initiation/promotion assay but did not initiate skin tumour development. 1,2-Dibromoethane was consistently genotoxic in in vitro assays, although results in in vitro assays were mixed. Biotransformation to active metabolites, which have been demonstrated to bind to DNA, is likely involved in the induction of tumours. Available data do not support the existence of a non-genotoxic mechanism of tumour induction. Therefore, based on the available data, it is concluded that there is sufficient evidence that 1,2-dibromoethane is a genotoxic carcinogen in rodents. As data on the potential carcinogenicity in humans are inadequate, and as it is likely that 1,2-dibromoethane is metabolized similarly in rodent species and in humans (although there may be varying potential for the production of active metabolites in humans, owing to genetic polymorphism), 1,2-dibromoethane is considered to be probably carcinogenic in humans, based on the results of studies in experimental species (IPCS, 1995, 1996). Similarly, IARC (1987) classified 1,2-dibromoethane in Group 2A (probably carcinogenic to humans). Considering the toxicological characteristics of 1,2-dibromoethane, both qualitatively and quantitatively , an exposure that would not cause adverse effects in humans after any route of exposure can not be estimated. Consequently, all appropriate measures should be taken to eliminate or minimize human exposure to 1,2-dibromoethane. Expected effect of the final regulatory action in relation to human health: Prevention of contamination in air, drinking-water and food. Minimizing cancer risks for humans. Date of entry into force of the final regulatory action: 01/08/2005 |