The objective of the two-generation reproductive toxicity study is to determine the effects of a pesticide on the integrity and performance of the male and female reproductive systems and on the growth and development of the offspring.  

The two-generation study aims to establish the no-observed-adverse-effect-levels (NOAELs) for parental toxicity, reproductive outcome and pup development.

 

The two-generation reproductive study is recommended if the pesticide is intended:

If it is claimed that such testing is unnecessary, that claim shall be fully justified.

 

The two-generation reproductive toxicity study is normally conducted with rats. If another mammalian species is used, a justification should be provided by the applicant.

 

 

The No Observed Adverse Effect Level (NOAEL) for parental toxicity, reproductive outcome and pup development are reported whenever possible.

Other typical endpoints of the study include, but are not limited to: indices of mating, fertility, gestation, birth, viability, and lactation; offspring sex ratio; precoital interval, including the number of days until mating and the number of estrous periods until mating; duration of gestation calculated from day 0 of pregnancy; sperm number and quality; survival, body weight, necropsy findings, histopathological findings.

 

The following test guidelines may be used for the two-generation reproductive toxicity study:

•OECD Guidelines for the Testing of Chemicals. Test No. 416: Two-generation reproduction study.

•OECD Guidelines for the Testing of Chemicals. Test No. 443: Extended one-generation reproductive toxicity study.

•US EPA Health Effects Test Guidelines. OPPTS 870.3800. Reproduction and fertility effects. 

•EC Testing Method B.35. Two-generation reproduction toxicity study. Council Regulation (EC) No 440/2008.