Alkenes, C13-14, hydroformylation products, distn. residues

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Study period:

Dose range finding study has been completed; draft report under review. Anticipated main study initiation March/April 2023.

Data waiving:

other justification

Justification for data waiving:

other:

Justification for type of information:

The data will be Read-Across from Alkenes, C11-12, hydroformylation products, distn. residues (EC 292-427-6) as described in the Read Across Justification Document (see section 13.2 'Assessment report - Read-across Justification 11152017').

We had anticipated submitting the OECD 443 study mentioned above by December 2022. This date itself was later than originally anticipated. Unfortunately, we have experienced additional delays that have further extended the timeline for this study. The current anticipated start date for the main study is now March/April 2023. The reason for the various delays in the project are summarized in what follows below.


- 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, working with ERBC, the dose range study has been completed (draft report in review) and the toxicokinetic evaluation procedure is being optimized. Once these preliminary steps are satisfactorily completed, the main OECD 443 study will be initiated.

Please see also attached letter from ERBC for study commitment confirmation and further information on study progress and scheduling.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information