Nitrile hydratase recombinant from E.coli

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment

Justification for type of information:

In accordance with Annex VIII of REACH, a study to address information requirement 8.7.1 (screening for reproductive and developmental toxicity) does not need to be conducted because relevant human exposure can be excluded in accordance with REACH Annex XI Section 3.

Furthermore, exposure will be well controlled because the DMEL (derived minimum exposure levels) to prevent respiratory allergy (supported by exposure scenarios and DMEL values included in the CSR). Respiratory allergy is generally considered to be the only human health hazard of enzymes indicating that this is the most sensitive endpoint considering enzyme toxicity. Concentrations that are not expected to result in respiratory allergy will not result in any other toxic effect.

It is also noted that the available toxicokinetic information indicates that the bioavailability of enzymes is low due to the fact that no significant absorption can be expected through the respiratory and/or gastrointestinal tract and/or through the skin.