Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The MW of recombinant eADF4(C48-CS25C) protein is 142.8 kDa and therefore the likelihood that the substance is capable of crossing biological membranes like the alveoli epithelial cell layer, interstium and the capillary endothelial cell layer very low.
Therefore. there is a low likelihood that an inhaled protein would cross into the systemic circulation to potentially cause pharmacological effects.

In addition,inhalation exposure during manufacturing is unlikely to occur (see attached justification).



Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion