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3.7.1.: Definitions and general considerations

3.7.1.1. Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. The definitions presented below are adapted from those agreed as working definitions in IPCS/EHC Document No 225, Principles for Evaluating Health Risks to Reproduction Associated with Exposure to Chemicals. For classification purposes, the known induction of genetically based heritable effects in the offspring is addressed in Germ Cell Mutagenicity (section 3.5), since in the present classification system it is considered more appropriate to address such effects under the separate hazard class of germ cell mutagenicity.

In this classification system, reproductive toxicity is subdivided under two main headings:

(a) adverse effects on sexual function and fertility;
(b) adverse effects on development of the offspring.

Some reproductive toxic effects cannot be clearly assigned to either impairment of sexual function and fertility or to developmental toxicity. Nonetheless, substances with these effects, or mixtures containing them, shall be classified as reproductive toxicants.

3.7.1.2. For the purpose of classification the hazard class Reproductive Toxicity is differentiated into:

 adverse effects

 

 on sexual function and fertility, or

 on development;

effects on or via lactation.
3.7.1.3. Adverse effects on sexual function and fertility
Any effect of substances that has the potential to interfere with sexual function and fertility. This includes, but is not limited to, alterations to the female and male reproductive system, adverse effects on onset of puberty, gamete production and transport, reproductive cycle normality, sexual behaviour, fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions that are dependent on the integrity of the reproductive systems.
3.7.1.4. Adverse effects on development of the offspring
Developmental toxicity includes, in its widest sense, any effect which interferes with normal development of the conceptus, either before or after birth, and resulting from exposure of either parent prior to conception, or exposure of the developing offspring during prenatal development, or postnatally, to the time of sexual maturation. However, it is considered that classification under the heading of developmental toxicity is primarily intended to provide a hazard warning for pregnant women, and for men and women of reproductive capacity. Therefore, for pragmatic purposes of classification, developmental toxicity essentially means adverse effects induced during pregnancy, or as a result of parental exposure. These effects can be manifested at any point in the life span of the organism. The major manifestations of developmental toxicity include (1) death of the developing organism, (2) structural abnormality, (3) altered growth, and (4) functional deficiency.
3.7.1.5. Adverse effects on or via lactation are also included in reproductive toxicity, but for classification purposes, such effects are treated separately (see Table 3.7.1 (b)). This is because it is desirable to be able to classify substances specifically for an adverse effect on lactation so that a specific hazard warning about this effect can be provided for lactating mothers.