Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Study period:
Studies currently underway with dossier submission by December 2022
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
Due to circumstances beyond our control and described below, the earliest we will be able to submit the final report for the OECD 443 study is approximately December 2022.

- In response to the global COVID-19 pandemic, state-enforced COVID-19 legislation results in significant operational limitations of the Sasol facilities and the ERBC facility, as well as with supporting facilities beginning in March 2020.

- The search for non-testing resolution was started three years ago. Several relevant consortia, both in the EU and in the United were queried to determine if there was pertinent mammalian toxicity study data for very high molecular weight residual materials. This was in an effort to prevent unnecessary animal testing.

- Once it was determined that no existing studies could be purchased, the decision was made to conduct the studies at a GLP-validated laboratory. The laboratory had to have extensive technical capability to conduct complex analytical work with this UVCB material, toxicokinetic evaluation of the test material and/or its metabolites, as well as the classical OECD 443 mammalian toxicity study.

- Once representative laboratories were identified, the Sasol Product Safety group evaluated the draft protocols and the financial group evaluated the quotations and placed the study with ERBC.

Currently, the analytical method development work is underway, the toxicokinetic evaluation procedure is being optimized and the OECD 421 range finding procedure is being optimized. Once these preliminary steps are satisfactorily completed, the main OECD 443 study will be initiation.

Please note that COVID-19 restrictions are expected to continue into 2021 and that inclement weather and hazardous travel conditions may further restrict facility operations.

Please see attached letter from ERBC.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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