Toxicity testing Sixth Amendment

To complete a registration, applicants must submit a voluminous dossier with technical data, ranging from the name of the substance to its physico-chemical properties and a base set of toxicity and eco-toxicity test results. While notifiers of new substances under the Sixth Amendment to Directive 67/548/EEC submitted this dossier to NRAs, new and existing substance producers and importers alike are now expected to report directly to ECHA. This shift deprives Member States of an early opportunity to communicate with the registrant and, where indicated, stage an early formal or informal intervention.22... 

However, none of these statutes were so directly focused on the chemical industry as the 1976 Toxic Substances Control Act (TSCA) in the United States and the Sixth Amendment to the Dangerous Substances Directive enacted by the European Parliament in 1979. These statutes did not focus on the industry s wastes, pollution or occupational exposures as much as on the intrinsic hazards - the toxicity, chemical stability, and bioavailability - of the industry s chemical products as they were used in commerce. These laws were intended to provide government agencies with the authority to collect relevant health and safety data on chemical products, require testing where data were missing, and condition and restrict the use of chemical substances so as to reduce unreasonable risks to the public and environment. 

The EC study methods are given in Annex V of the Directive. The Base Set tests are published as Commission Directive 92/69/EEC [23], which is the update to the methods of Commission Directive 84/449/EEC [24] used for Sixth Amendment notifications. Some of the methods fw Level 1 studies are contained in Commission Directive 87/302/EEC [25]. The EC methods closely parallel the OECD Guidelines [26]. The Annex V methods must be followed unless deviation is scientifically justified. Omission of a Base Set test for technical reasons must also be justified. Tests must be performed in compliance with GLP. In view of Council Directive 86/609/EEC [27] on the protection of experimental animals, tests on animals are to be pexformed as humanely as possiUe, and limit tests are accqrtable for substances only toxic under extreme conditions. 

In particular, the Toxic Substances Control Act (US EPA, 1978) in the U SA and the Sixth Amendment to the Directive on Dangerous Substances (EEC Council Directive, 1979) in Europe require the development of a basic set of information before a new chemical substance may be marketed. The required data set dealt with several characteristics of the substance (chemical structure, use patterns, physico-chemical properties, analytical methods, etc.) and includes toxicological and ecotoxicological tests at different levels of complexity in relation to the amount of the substance produced and the results at the preliminary levels (see Table 1). 

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