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 tertiary butyl acetate to cause dermal sensitization is well understood. In the key study, a Buehler test conducted according to EPA OPP Guideline 81-6, a concentration of 100% tertiary butyl acetate at challenge did not cause a sensitization reaction in ten male guinea pigs previously induced with three separate six-hour epicutaneous, occlusive exposures performed once per week for three weeks.

Justification for classification or non-classification

No evidence of a sensitization response was observed in a guideline dermal sensitization study conducted in guinea pigs. Tertiary butyl acetate is not classified for dermal sensitization according to EU CLP (Regulation (EC) No. 1272/2008) and UN GHS.