Registration Dossier

Diss Factsheets

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The bioactivity of Alcohols C12-13, branched and linear, ethoxylated (1-2,5 EO) sulphated, sodium salts (SPES) was assessed in a battery of in vitro tests relevant to systemic, reproductive, and developmental toxicity. Concentration-response curves were derived for 36 cell stress markers measured in HepG2 Cells and High Throughput Transcriptomics was conducted in HepG2, HepaRG and MCF7 cells. In vitro pharmacological profiling (IPP) of SPES against 73 targets was conducted, with specific follow-up with CALUX functional assays where necessary. Specific assays relating to developmental toxicity (Reprotracker, devTOXqp) were also conducted. Lowest reported Points of Departure (PoDs) were adjusted to correct for the activity of SPES (69.42%), and ranged from 1.1 - 89.8 µM. 


This data was used in a Next Generation Safety Assessment (NGSA), which is an exposure-led approach to safety assessment that employs the use of these New Approach Methodologies (NAMs). A full description of this approach can be found in Section 13.2 (Narrative Document/Next Generation Safety Assessment).

Additional information