Chemical name: [1,1-biphenyl]-4,4-diamine, Benzidine and its salts

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 benzidine 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 Tissues intended as consumer goods.

Use or uses that remain allowed:

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, benzidine ands 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 thse 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 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:

Animal carcinogenicity data: Benzidine is carcinogenic in the mouse, rat and hamster, and possibly the dog. Given orally, it has produced bladder carcinoma in the dog after a long latent period and liver tumours in the rat and hamster.

Human carcinogenicity data: The epidemiological studies showed that occupational exposure to commercial benzidine alone was strongly associated with bladder cancer. In the same studies, exposure to 2-naphthylamine alone was similarly associated with bladder cancer. A number of case reports from several countries supported the relationship between this neoplasm and occupational exposure to benzidine.

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

Minimizing cancer risks for population in Switzerland.

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