Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In the guinea pig Optimization test 1,6-Hexanediol Diglycidylether (HDDGE) at a concentration for challenge of 1% wt/v elicited positive dermal reactions in all 20 animals. In the mouse LLNA asay HDDGE had an Estimated Concentration 3 of 1.9% based on DPMs suggesting that HDDGE is a moderate dermal sensitizer. Based on the results of the mouse LLNA study and applying E.C.H.A. guidance (RIP Chapter 8) the Worker dermal DMEL/DNEL is estimated to be 22.6 ug/cm2.

Migrated from Short description of key information:
1,6-Hexanediol Diglycidylether (HDDGE) was accessed for dermal sensitizing potential in a guinea pig Optimization test and a O.E.C.D. Testing Guideline mouse LLNA assay conducted with GLP compliance. HDDGE gave a positive skin sensitizing response in both studies.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data

Justification for classification or non-classification

The positive findings from both the guinea pig Optimization test and the mouse LLNA study are sufficient to support the Classification and Labeling of 1,6 -Hexanediol Diglycidylether (HDDGE) as R43, "May cause sensitization by skin contact".