Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

EOGRTS


This information will be submitted later based on ECHA Communication/ Decision Number CCH-D-2114373450-54-01/F of 13 November 2017.

Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

EOGRTS


This information will be submitted later based on ECHA Communication/ Decision Number CCH-D-2114373450-54-01/F of 13 November 2017.


Various letters have been submitted on behalf of PMC Vlissingen and the OrganoTin REACH Consortium to ECHA and The Netherlands Authorities detailing the issues and delays that have been encountered in completing this study.
Extended one-generation reproductive toxicity study (EOGRTS) (Annex IX, Section 8.7.3; test method: OECD TG 443) in rats: An initial dose range-finding study using a dietary route of exposure was started in early July 2021 and the in-life phase of the study finished mid-October 2021. The draft report was issued in January 2022 and is currently in the process of being finalized. Unfortunately the dose levels selected for this study did not give the expected results, with the high and mid dose showing excessive maternal toxicity. Consequently the low dose, which was expected to be the NOAEL for the EOGRTS, needs to be the top dose level, with further lower doses now needing to be considered. This has caused further complications in that it has not been possible to validate an analytical method to demonstrate stability of the formulations at the new lower dose levels which will required. After significant investigations it was determined that the only way to proceed with testing was to change the dose route to oral gavage (the developmental study using this route of exposure showed that it should be possible to validate a method at the levels required). This change has meant that a new dose range-finding study has been required using oral gavage; this was initiated late January 2022 and the in-life phase was finished late March 2022. The draft report is due to be issued early June, but the results have been shown to give the information needed to set the dose levels for the EOGRTS.
The EOGRTS is planned to commence early June 2022; assuming the F2-generation is not triggered, the study will finish late December 2022, with the draft report due to be issued mid-May 2023. As soon as the final report is available (it should be noted that, due to the nature of this study, it could easily take 2 to 3 months for it to be reviewed and finalised, possibly longer depending upon the findings) then the data will be incorporated into the registration dossier, the CSR revised and an update will be submitted to ECHA. Overall, based on the current study schedules we would anticipate that the registration including all the new data required to meet the Decision on a compliance check will be submitted Q4 2023 (this could be extended if the F-2 generation is triggered on the EOGRTS).

Effects on developmental toxicity

Description of key information

Pre-natal developmental toxicity study


This information will be submitted later based on ECHA Communication/ Decision Number CCH-D-2114373450-54-01/F of 13 November 2017.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Pre-natal developmental toxicity study


This information will be submitted later based on ECHA Communication/ Decision Number CCH-D-2114373450-54-01/F of 13 November 2017.


Various letters have been submitted on behalf of PMC Vlissingen and the OrganoTin REACH Consortium to ECHA and The Netherlands Authorities detailing the issues and delays that have been encountered in completing this study. Following an exhaustive investigation into the conduct of the initial study that was carried out, along with a review of the data by an independent expert foetal pathologist, it was determined that the original study performed was not acceptable and did not meet the requirements of the EU B.31./OECD TG 414 guidelines. The study therefore needed to be repeated.
Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method: OECD TG 414) in a first species (rat): The simplified dose-range finding for the repeat developmental toxicity study in rats was initiated mid-February 2021 and finished early March 2021. The draft report for the study was issued mid-May 2021 and finalized mid-July 2021. The main developmental study commenced late March 2021 and the in-life phase finished mid-April 2021. The draft report was issued late August 2021 and has been undergoing a thorough review by Exponent’s toxicologists as the consultants monitoring the study and then by the toxicologists of the Organotin REACH Consortium. This review is nearing completion and so it is expected that the final report will be available Q2 2022. As soon as the final report is available then the data will be incorporated into the registration dossier, the CSR revised and an update will be submitted to ECHA. Overall based on the current study schedules we would anticipate that an update to the registration including this data will be submitted Q3 2022.


 

Justification for classification or non-classification

In accordance with Annex VI of the CLP Regulation, the substance has a harmonised classification and as such must be classified as a reproductive toxicant Category 2 (H361: Suspected of damaging fertility or the unborn child).

Additional information