OECD Guidelines for the Testing of Chemicals, Section 4
- ISSN :
- 2074-5788 (online)
- DOI :
The OECD Guidelines for the Testing of Chemicals is a collection of about 100 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of new and existing chemical substances, chemical preparations and chemical mixtures. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification and chemical registration. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research. This group of tests covers health effects.
Test No. 421: Reproduction/Developmental Toxicity Screening Test
- Publication Date :
- 27 July 1995
- Pages :
- ISBN :
- 9789264070967 (PDF)
- DOI :
Show Abstract /
The test substance is administered in graduated doses to several groups of males and females.
Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 54 days. This Test Guideline is designed for use with the rat. It is recommended that each group be started with at least 10 animals of each sex. Generally, at least three test groups and a control group should be used. Dose levels may be based on information from acute toxicity tests or on results from repeated dose studies. The test substance is administered orally and daily. The limit test corresponds to one dose level of at least 1000 mg/kg body weight. The results of this study include measurements (weighing, food/water consumption) and daily and detailed observations, preferably each day at the same time, as well as gross necropsy and histopathology. The findings of this toxicity study should be evaluated in terms of the observed effects, necropsy and microscopic findings. Because of the short period of treatment of the male, the histopathology of the testis and epididymus must be considered along with the fertility data, when assessing male reproductive effects.