Conventional Test Method:

One-Generation Reproduction Toxicity Study (OECD TG 415) AND Two-Generation Reproduction Toxicity Study (OECD TG 416)
Developmental Neurotoxicity Study (OECD TG 426) AND Prenatal Developmental Toxicity Study (OECD TG 414)

Alternative Test Method:

Name & Description:

Extended One-Generation Reproduction Toxicity Study

This test protocol can serve as an alternative to other protocols intended to examine reproductive toxicity (OECD 415, 416) and can also help to determine the need for specific developmental toxicity studies (OECD 426, 414) or potentially replace them. The study design provides flexibility and a more efficient testing approach by stressing the importance of starting with existing knowledge and using in-life observations to guide and tailor the testing.

Validation Status:

No information

Regulatory Status:

OECD: TG 443

Effect or Potential Effect on Animal Use:

(Use of fewer animals; more data collected from each animal)

  • Cooper R.L., Lamb  J.C., Barlow S.M., Bentley K., Brady A.M., Doerrer N.G., Eisenbrandt D.L., Fenner-Crisp P.A., Hines R.N., Irvine L.F.H., Kimmel C.A., Koeter H., Li A.A., Makris S.L., Sheets L.P., Speijers G.J.A and Whitby K.E. (2006) A tiered approach to life stages testing for agricultural chemical safety assessment. Critical Reviews in Toxicololgy 36:69-98.
  • International Life Sciences Institute (ILSI) (2009) Extended F1 One Generation Reproductive Toxicity Study (presentation to US EPA).
  • OECD (2011) TG 443 Extended One-Generation Reproductive Toxicity Study.
Information Last Reviewed:
May 2012