How are reproductive toxicity and developmental toxicity addressed in REACH dossiers?

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Costanza Rovida
Fabiola Longo
Richard R. Rabbit


The first deadline for REACH registration has passed and registration data for the first set of substances are now public. According to ECHA, 4,599 substances have been registered so far, and the corresponding dossiers of many of them are now partially available in a public database. A sample of 400 records was randomly selected and analyzed with regard to reproductive and developmental toxicity. Most dossiers do not follow the strict requirements in the official guidelines, and some dossiers lack some very basic information. A broad variety of existing data is used, and the read-across opportunity is very much exploited. Surprisingly, a number of in vivo tests have been performed already, apparently for REACH purposes, in spite of the legal requirement to make a public proposal and wait for authorization by ECHA. The number of animals used so far, plus the number of animals that will derive from testing proposals of the first REACH deadline, is very high; it may add up to 1.6 million animals just to accomplish reproductive and developmental toxicity endpoints if the data collected from 400 dossiers are extrapolated to the total number of registered substances. In vitro tests are completely absent, even though there are many tests that may be used to complement either read-across strategies or partially reliable existing data. It is recommended, in the spirit of REACH, to protect human health through an in-depth assessment of the chemicals and simultaneously, to promote the use of in vitro alternatives.

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Rovida, C., Longo, F. and Rabbit, R. 2011. How are reproductive toxicity and developmental toxicity addressed in REACH dossiers?. ALTEX - Alternatives to animal experimentation. 28, 4 (Nov. 2011), 273-294. DOI:

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