# The Notification of New Substances Regulations 1993, Chapter: Toxicological studies


The test programme shall cover the following aspects unless there are strong reasons to the contrary, supported by evidence, that it should not be followed:
Chronic toxicity study.
Carcinogenicity study.
Fertility study (e. g. three-generation study): only if an effect on fertility has been established at level 1.
Developmental toxicity study on perinatal and postnatal effects.
Teratology study (species not employed in the respective level 1).
Additional toxicokinetic studies which cover biotransformation, pharmokinetics.
Additional tests to investigate organ or system toxicity.

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Source: https://www.legislation.gov.uk/uksi/1993/3050/schedule/3/part/2/chapter/1 (the official version)
Page: https://openlegislation.uk/notification-of-new-substances-regulations-1993/schedule-3/part-2/chapter-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.