Event:406

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Event Title

Fertility, impaired

Key Event Overview

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AOPs Including This Key Event

AOP Name Event Type Essentiality
Aromatase (Cyp19a1) reduction leading to impaired fertility in adult female AO
PPARα activation leading to impaired fertility in adult male rodents AO
PPARα activation in utero leading to impaired fertility in males AO

Taxonomic Applicability

Name Scientific Name Evidence Links
rat Rattus rattus Strong NCBI
mouse Mus musculus Strong NCBI
human Homo sapiens Strong NCBI

Affected Organs

Synonym Scientific Name Evidence Links

Level of Biological Organization

Biological Organization
Individual

How this Key Event works

Biological state

capability to produce offspring

Biological compartments

System

General role in biology

Fertility is the capacity to conceive or induce conception. Impairment of fertility represents disorders of male or female reproductive functions or capacity.

How it is Measured or Detected

Methods that have been previously reviewed and approved by a recognized authority should be included in the Overview section above. All other methods, including those well established in the published literature, should be described here. Consider the following criteria when describing each method: 1. Is the assay fit for purpose? 2. Is the assay directly or indirectly (i.e. a surrogate) related to a key event relevant to the final adverse effect in question? 3. Is the assay repeatable? 4. Is the assay reproducible?


As a measure, fertility rate, is the number of offspring born per mating pair, individual or population.

Evidence Supporting Taxonomic Applicability

Regulatory Examples Using This Adverse Outcome

Under REACH, information on reproductive toxicity is required for chemicals with an annual production/importation volume of 10 metric tonnes or more. Standard information requirements include a screening study on reproduction toxicity (OECD TG 421/422) at Annex VIII (10-100 t.p.a), a prenatal developmental toxicity study (OECD 414) on a first species at Annex IX (100-1000 t.p.a), and from March 2015 the OECD 443(Extended One-Generation Reproductive Toxicity Study) is reproductive toxicity requirement instead of the two generation reproductive toxicity study (OECD TG 416). If not conducted already at Annex IX, a prenatal developmental toxicity study on a second species at Annex X (≥ 1000 t.p.a.).

Under the Biocidal Products Regulation (BPR), information is also required on reproductive toxicity for active substances as part of core data set and additional data set (EU 2012, ECHA 2013). As a core data set, prenatal developmental toxicity study (EU TM B.31) in rabbits as a first species and a two-generation reproduction toxicity study (EU TM B.31) are required. OECD TG 443 (Extended One-Generation Reproductive Toxicity Study) shall be considered as an alternative approach to the multi-generation study.) According to the Classification, Labelling and Packaging (CLP) regulation (EC, 200; Annex I: 3.7.1.1): a) “reproductive toxicity” includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring; b) “effects on fertility” includes adverse effects on sexual function and fertility; and c) “developmental toxicity” includes adverse effects on development of the offspring.

References