Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Six different skin sensitization assays have been performed in Guinea pigs with slightly different protocols, especially concerning the induction phase using Freund's adjuvant for intradermal indiction other other means for epidermal induction.

In each case TGIC proved to be a weak to strong skin sensitizer. With most scientific studies performed it was a moderate skin sensitizer which is in agreement with Human case studies in which several workers exposed excessively to TGIC developed over months or even years allergic reactions to TGIC and in many cases also to other epoxides.

Epoxides in general are known to be skin sensitizers in Guinea pigs and Humans.


Migrated from Short description of key information:
In several Guinea pig maximization studies TGIC proved to be a moderate skin sensitizer. Depending on the design of the study and the way the substance was applied, the degree of sensitization varied, but most of the studies showed a clear positive result.
This was also cofirmed in a variety of Human case studies , reported under section 7.12 Additional toxicological information.

Respiratory sensitisation

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

TGIC is a well known skin sensitizer in Guinea pigs. This toxicological property is not surprising as most of the epichlorohydrin-based epoxides are more or less strong skin sensitizers. Also, a number of human case reports support the fact that epoxides including TGIC are Human skin sensitizers among occupationally imvolved wrrokers.

However, none of the epoxy resins and reactive diluents (on the basis of epoxy functional groups) have caused respiratory sensitization in Humans. Very few case reports , especially from Sweden and Denmark, claimed respiratory sensitization due to epoxy resins and TGIC, but none could prove the the respiratory irritation observed was a true allergic reaction.

Thus, TGIC is an established skin sensitizer , but not a resiratory sensitizer.


Migrated from Short description of key information:
No animal studies have been conducted on respiratory sensitization of the substance.
Human studies on occupational sensitization found several cases of skin sensitization, but only one case of respiratrory irritation. Whether this case was actually respiratory sensitization is unclear and has not been proven.

Justification for classification or non-classification

Based on the studies presented, the classification as an skin sensitizer , Xi and R 43, is justified for this substance