Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Two GLP studies were conducted, to determine the skin sensitisation potential of Cyclic trimethylolpropane (CTF) and Dimethylolpropane Tech (DMP Tech) (Robinson, 2010) using the LLNA (OECD 429). Under the conditions of the studies, since treatment with DMP Tech or CTF at concentrations of up to 100% did not achieve stimulation index values of ≥3, it was considered that the test items did not have the potential to cause sensitisation.

There is no evidence from experience of use that the substance or its components has the potential to cause skin sensitisation in exposed workers.


Migrated from Short description of key information:
Negative LLNA results are reported for DMP and CTF. There is no evidence from experience of use that the substance or its components has the potential to cause respiratory sensitisation in exposed workers.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No animal data are available. There is no evidence from experience of use that the substance or its components has the potential to cause respiratory sensitisation in exposed workers.


Migrated from Short description of key information:
No animal data are available. There is no evidence from experience of use that the substance or its components has the potential to cause respiratory sensitisation in exposed workers.

Justification for classification or non-classification

The Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP) is not classified as a skin sensitiser based on negative LLNA results with the components DMP and CTF. The other component TMP is not considered to be a skin sensitiser based on read-across from DMP. There is no evidence from experience of use that the substance has the potential to cause skin or respiratory sensitisation in exposed workers. No classification is therefore proposed under Directive 67/548/EEC or Regulation (EC) No 1272/2008.