Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

The registered substance is classified as reproductive hazard based on the presence of an impurity (phenol, dodecyl-,branched; AKA TPP with CAS 121158 -58 -8). However, the substance itself is an alkaryl ZDDP and is not expected to cause reproductive effects based on read across from alkyl ZDDPs (i.e., this functional group is not associated with reproductive toxicity based on multiple studies for this category).

The amount of residual TPP is used in the risk assessment for potential reproductive toxicity, which is sufficient to address the potential hazards of the substance as a whole.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

This substance is classified under GHS as a category 1B reproductive hazard based on the presence of the impurity tetrapropenyl phenol (EC No. 310-154-3). However, the substance itself is not expected to be a reproductive toxicant based on read across to analogs with the same functional groups (alkyl ZDDPs).