Division 3.7.2.3.1

Classification as a reproductive toxicant is made on the basis of an assessment of the total weight of evidence, see section 1.1.1. This means that all available information that bears on the determination of reproductive toxicity is considered together, such as epidemiological studies and case reports in humans and specific reproduction studies along with sub-chronic, chronic and special study results in animals that provide relevant information regarding toxicity to reproductive and related endocrine organs. Evaluation of substances chemically related to the substance under study may also be included, particularly when information on the substance is scarce. The weight given to the available evidence will be influenced by factors such as the quality of the studies, consistency of results, nature and severity of effects, the presence of maternal toxicity in experimental animal studies, level of statistical significance for inter-group differences, number of endpoints affected, relevance of route of administration to humans and freedom from bias. Both positive and negative results are assembled together into a weight of evidence determination. A single, positive study performed according to good scientific principles and with statistically or biologically significant positive results may justify classification (see also 3.7.2.2.3).