Chemical name: 1,1'-Biphenyl, 4-nitro- Final regulatory action has been taken for the category: Industrial Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: ORRChem: - According to Annex 1.13, the placing on the market and use of 4-nitrobiphenyl or preparations containing 0.1% weight or more of this substance are banned. - According to Annex 1.10 on the substances classified as carcinogens, mutagens or toxic to reproduction, the packaging of substances and preparations subject to the prohibition must be marked: "Reserved for commercial use" OUA: Articles cannot contain any of the azo dyes that can release aromatic amines like 4-aminobiphenyl, by reduction of one or more azoic groups, to a concentration higher than 30 mg/kg or the article (art 26a). The utility articles that shall not contain any azo-dye are textiles and leather goods that come into contact with the human body like (Annex 3): a.clothes, bed clothes, sleeping bag, toilet towels, wigs, hats, nappies and other hygienic articles b. shoes, gloves, straps, belts, handbags, purses/wallets, briefcases c. tissue or leather toys and toys that contain tissue or leather accessories d Tissues intended as consumer goods. Use or uses that remain allowed: Exceptions of ORRCHem: - The ban does not concern the placing on the market and use for research purposes. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: In Switzerland, 4-nitrobiphenyl is classified as a category 2 carcinogen and cannot be obtained in a private capacity. As in the EU, the placing on the market and use of these substances are banned, as well as the preparations containing thse substances at a concentration of 0.1% or more (Ordinance on the Reduction of Risks linked to Chemical Products ORRChem). There is an exception on the use for analytical and research purposes. This exception takes into consideration that often no substitutes of these substances exist for analytical purposes. The azo-dyes used in textile or leather articles, that can release arylamines like 4-nitrobiphenyl, are also subject to the requirements of the Ordinance on Utility Articles (OUA) recently updated. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: 4-Nitrobiphenyl is a group 3 substance (the agent (mixture or exposure circumstance) is not classifiable as to its carcinogenicity to humans). Animal carcinogenicity data: 4-nitrobiphenyl induced carcinomas of the bladder when given orally to dogs, the only species and route known to have been tested. Human carcinogenicity data: There are no data on the carcinogenicity of 4-nitrobiphenyl in man. However, it has been used in the production of 4-aminobiphenyl, which is a recognized human bladder carcinogen. Expected effect of the final regulatory action in relation to human health: Minimizing cancer risks for the population in Switzerland Date of entry into force of the final regulatory action: 01/08/2005 |