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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
April 20, 2022 DRT has received (Annotation number TPE-D-2114592241-52-01/F) in REACH IT a NOTIFICATION OF AN ADOPTED DECISION ON TESTING PROPOSAL. DRT has been requested to conduct a Pre-natal developmental toxicity study (test method: OECD TG 414) by oral route, in one species (rat or rabbit) and to update our REACh dossier before April 27, 2023. DRT has contracted with a CRO (ERBC) March 25, 2022 to conduct the required study. As of today (2023-03-21) DRT has just received a first audited draft report from the CRO. We still need to comment on it (couple of weeks) and then we need to flll the RSS in IUCLID , update the dossier and submit the dossier. As a result we will miss the deadline set by ECHA despite our full engagement and the engagement of the CRO to meet the deadline. We are anticipating to update our IUCLID dossier before end of July. A letter prepared by the CRO (ERBC) has been attached to this endpoint study record.

Data source

Materials and methods

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion