Chemical name: [1,1'-Biphenyl]-4-amine 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-aminobiphenyl and its salts or preparations containing 0.1% weight or more of these substances 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 Threads and 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-aminobiphenyl and its salts are classified as category 1 carcinogens and cannot be obtained ina private capacity. As in the EU, the placing on the market and use of these substances are banned, as well as the preparations containing these substances at a concentration of 0.1% ormore (Ordinance on the Reduction of Risk related to Chemicals, ORRChem). As the ban already exists in the EU since 1989, no transition time has been fixed in Switzerland. 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 textiles or leather articles, that can release arylamines like 4-aminobiphenyl and its salts, are also subject to teh 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: Animal carcinogenicity: 4-aminobiphenyl is carcinogenic in the mouse, rat, rabbit and dog. Following its oral administration it has produced bladder and liver tumours in mice and bladder papillomas and carcinomas in rabbits and dogs. Human carcinogenicity: In the epidemiological studies, confined to one series of workers occupationally exposed to commercial 4-aminobiphenyl, a high incidence of bladder carcinoma was reported. In consequence one can say that bladder cancer was strongly associated with occupational exposure to 4-aminobiphenyl. 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 |