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:

The potential for di (2-ethylhexyl) terephthalate to cause dermal sensitization is well understood. In a human repeat insult patch test conducted according to acceptable scientific methodology and Good Clinical Practices, 203 test subjects were induced by application of 0.2 mL of a 0.5% solution of the test material to the back of each test subject three times a week for three weeks. The application sites were semi-occluded and patches were evaluated for signs of irritation at 48-72 hours after application. Only slight erythema was observed for one to seven subjects at any given time during the induction phase. Following a single open challenge application using naïve sites on the back, only one subject exhibited erythema. Under the conditions used in this study, di-(2-ethylhexyl) terephthalate did not elicit dermal sensitization. In a non-guideline supporting study conducted according to an internal Eastman Kodak Company method in which guinea pigs were induced with di (2-ethylhexyl) terephthalate using the footpad technique and challenged seven days later via dermal application, there was no increased incidence of erythema or edema in any animal.

Justification for classification or non-classification

No evidence of a sensitization response was observed when human volunteers were induced with di (2-ethylhexyl) terephthalate by application of 0.2 mL of a 0.5% solution of the test substance to the back three times a week for three weeks under semi-occlusive contact and then challenged at naïve sites on the back following a 10-17 day rest period. In addition, there was no evidence of a sensitization response when guinea pigs were immunized with di (2-ethylhexyl) terephthalate by the footpad technique and challenged via dermal application. Di (2-ethylhexyl) terephthalate was not previously classified under Directive 67/548/EEC, i.e., Annex I of the Dangerous Substances Directive for skin sensitization. Based on a weight-of-the-evidence assessment, di (2-ethylhexyl) terephthalate would not be classified for skin sensitization according to the UN Globally Harmonized System of Classification and Labeling (GHS) or the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) no. 1272/2008.