OUR OCCUPATIONAL EXPOSURE LIMIT (OEL) REPORTS

Several hundred APIs substances OEL-OEB reports have already been developed.

  New reports are regularly developed internally by Toxby.design experts team and below database is updated weekly.

Any OEL-OEB report can be developed upon request.

Our rates of OEL-OEB reports are based on the status of development for such active substance, and discounts can be granted upon scale up quantities.

Protection of Workers from the Risk of Chemical Agents and fixation of an Upper Exposure Limit: OEL

Occupational Exposure Limits ("OEL") are regulatory values

  which indicate levels of exposure to be safe (health based)

  for a chemical substance in a work place.

OELs are adopted under 2 EU legal frameworks:

• Chemical Agents Directive (Directive 98/24/EC) and
• Carcinogens and Mutagens Directive (Directive 2004/37/EC)

As stated in the Questions and answers EMA/CHMP/CVMP/SWP/246844/2018, Health Based Exposure Limits,

  i.e. PDEs but as well OELs, are required for all medicinal products and have to be established by toxicological experts.

OEL value is used as data, to assign the chemical in a category or band, to which correspond

• containment measures and
• personal protective equipment

Determination of an OEL involves:

The derivation of occupational exposure limit is based on the equation published by Galer et al. (1992), Naumann and Weideman (1995), Sargent and Kirk (1988), and Schwartz (1995):

• from a NOAEL/LOAEL,
• human body weight,
• safety factors and
• human breathing rate.

For one API, OELs are calculated considering all sensitive species.

  NOEL in healthy volunteers as the highest exposure level

  at which there are no effects (adverse or non adverse) has preference to calculate an OEL more than NOAEL in animals.

Safety concerns detailed in the Risk Management Plan of the medicine are reviewed in order to detect other critical effects in humans.

  Hazard statements and precautionary statements prevention and response according to CLP, are given.

From those toxicological criteria and for the specific work conditions, 

  is determined an OEL category according the NTP 1104, INSHT or Safebridge banding schemes.