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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
The requirement for a two-generation reproductive toxicity study (as required under section 8.7.3 of Annex IX) will be considered once the outstanding issues concerning the OECD 422 study are resolved.

This section will be completed upon availability of the finalised OECD 422 study report.


Short description of key information:
A screening for reproductive / developmental toxicity study (as required under section 8.7.1 of Annex VIII) has been conducted according to OECD Guideline 422. Upon review of the draft study report the validity of the study has been called into question because of the high number of non-pregnant females and total litter losses observed in the treated groups during the study period. Discussions between the laboratory which conducted the study and representatives of the registrants are ongoing. As soon as this matter is resolved a registration update will be provided to include data to address this endpoint.

Effects on developmental toxicity

Description of key information
A screening for reproductive / developmental toxicity study (as required under section 8.7.1 of Annex VIII) has been conducted according to OECD Guideline 422. Upon review of the draft study report the validity of the study has been called into question because of the high number of non-pregnant females and total litter losses observed in the treated groups during the study period. Discussions between the laboratory which conducted the study and representatives of the registrants are ongoing. As soon as this matter is resolved a registration update will be provided to include data to address this endpoint.  The requirement for a pre-natal developmental toxicity study (as required under section 8.7.2. of Annex IX) will be considered once the outstanding issues concerning the OECD 422 study are resolved. 
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
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
The requirement for a pre-natal developmental toxicity study (as required under section 8.7.2 of Annex IX) will be considered once the outstanding issues concerning the OECD 422 study are resolved.

This section will be completed upon availability of the finalised OECD 422 study report.

Justification for classification or non-classification

Pending availability of the finalised OECD 422 study, the substance does not require classification for reproductive or developmental toxicity effects under Regulation (EC) No 1272/2008.

Additional information