Experiences with the test scheme under the chemical control law of Japan: An approach to structure—activity correlations

Abstract

Since the Chemical Control Law of Japan came into force in 1974, the premanufacture (preimportation) notifications under the Law have been submitted to MIT1 for 800 new chemical substances. Two hundred sixty of the existing chemical substances listed by MIT1 have been tested for biodegradability and bioaccumulation potential. After 5 years of experience the Japanese premanufacture notification system has functioned well to achieve the purpose of the Law which is to prevent potentially dangerous hazards to environment and to human health caused by chemical substances. Japanese premanufacture notification system of a chemical substance has three features which seem to make the system itself practicable, rational, and effective for the assessment of the potential hazards to the environment. The first point is that the Japanese notification system is not notification itself, but includes licensing procedures by the Government. The necessary technical dossier notified by industry is fully examined by the Ministry of International Trade and Industry (MITI) or Ministry of Health and Welfare. After such examination, both ministries announce only the name of a substance (based on IUPAC nomenclature) on the official Gazettes which is authorized to be manufactured or imported. Second, evaluation criteria are clearly defined under the Law. These criteria are following. (i) whether a chemical substance tends easily to be chemically changed by natural environmental effects, (ii) whether such a substance tends to accumulate in organisms, (iii) whether such a substance is potentially harmful to human health through its continuous ingestion or exposure: it is especially stressed that when a chemical substance in question is hydrolitically or photolitically changed into any daughter chemicals under the environmental conditions, the parent substance is evaluated from the above-mentioned data of each daughter chemical. According to such criteria, data for the notification requested under the Law are (i) identification for a new chemical substance (IUPAC name, chemical structure formula and some of physicochemical properties), (ii) annual production quantity during 3 years and use pattern, (iii) stability and composition including impurities, and (iv) data on one of (bio)degradation, bioaccumulation, or chronic toxicity. Lastly, the Law provides that the known or already submitted data satisfying regulations can be used for the assessment of degradability, accumulation