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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

screening for reproductive / developmental toxicity
Data waiver
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
Delay in study finalisation

The lab is currently experiencing longer than normal lead times for both the safety assessment studies and the supporting Bioanalysis, this has resulted in extended reporting schedules across the program of studies commissioned. Therefore the registrant will not be able to submit the final reports within the time frame specified by ECHA (ECHA decision number CCH-D-2114471566-40-01/F).
An explanatory statement of the lab is attached to IUCLID section 13.2.

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion