Please note, this OEL/ADE monograph also applies to eucalyptus extract (CAS RN 84625-32-1). The herbal substance consists of the fresh leaves or fresh terminal branchlets of various species of eucalyptus rich in 1,8-cineole (also known as eucalyptol) from which the oil is obtained by steam distillation and rectification. The three species mainly used are Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and Eucalyptus smithii R.T. Baker. Eucalyptus belongs to the family of myrtaceae and subfamily myrtoideae. There are more than 700 species in the genus.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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