Chemical name: Ethane, 1,2-dichloro-

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 ar 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:

Based on available data, 1,2-dichloroethane is considered to have a carcinogenic potential (IARC Group 2B), and therefore exposure should reduced to the extent possible. The carcinogenic potency (expressed as the dose associated with a 5% increase in tumour incidence), derived on the basis of studies in which animals were exposed by gavage, was calculated to be 6.2-34 mg/kg body weight per day. Guidance values for air (the principal source of human exposure) of 3.6-20 µg/m³ or 0.36-2.0 µg/m³ , calculated on the basis of a margin 5000 - or 50 000- fold less than the estimated carcinogenic potency, have been derived; however, it should be noted that risks are overestimated on this bases, as available data indicate that 1,2-dichloethane is less potent when inhaled. (Corresponding values for ingestion are 1.2-6.8 µg/kg body weight per day or 0.12-0.68 µg/kg body weight per day). These values correspond to those considered by some agencies to represent essentially negligible risk (i.e. 10^-5 to 10^-6 for genotoxic carcinogen). Based on a sample estimate, indirect exposure in the general environment is up to approximately 300 times less than these values.

Expected effect of the final regulatory action in relation to human health:

Minimizing cancer risks for humans.

Date of entry into force of the final regulatory action: 01/08/2005