Chemical name: 2-Naphthalenamine 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 2-naphthylamine 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: Ordinary articles that shall not contain any of the azo -dyes releasing aromatic amines (art 26a): Textiles and leather articles that can enter in contact directly and sufficiently with the human body like: 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: Exemptions of ORRChem - The ban does not concern the trade and use for research purposes - According to art. 26a of the ordinance OUA, the ordinary articles cannot contain azo-dyes that can release, by release of one or more azoic groups, the aromatic amines like 2-naphthylamine in higher concentration of 30 mg/kg or article (threshold). The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: In Switzerland, 2-naphthylamine and its salts are classified as category 1 carcinogens, 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 these substances at a concentration of 0.1% or more (Ordinance on the Reduction of Risks linked to Chemical Products 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 2-naphthylamine and its salts, are also subject to the requirements of the Ordinance on Utility Articles (OUA) recently updated. According to the Ordinance on Air Pollution Control (OAPC), 2-naphthylamine is considered as a carcinogen of Class 1. That means that the concentration of emissions of 2-naphthylamine cannot exceed the limit value of 0.1 mg/m3. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: Animal carcinogenicity data: 2-naphthylamine is carcinogenic in the mouse, hamster, dog and monkey. Given orally it has produced bladder carcinoma in the dog and monkey, and, at high dosage levels, in the hamster. By this route, it has increased the incidence of hepatomas in the mouse; in the rat and rabbit, it has little, if any, carcinogenic effect. Human carcinogenicity data: Epidemiological studies have shown that occupational exposure to 2-naphthylamine, either alone or when present as an impurity in other compounds, is strongly associated with the occurrence of bladder cancer. There is no doubt that 2-naphthylamine is a 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: 15/12/2005 ORRChem - 1 August 2005 OUA - 1 July 1995, last updated 15 December 2005 OAPC - 1 March 1986, last update 12 July 2005. |