Registration Dossier

Administrative data

First-aid measures

Fire-fighting measures

Accidental release measures

Handling and storage

The substance is an intermediate to produce an API and an other intermediate.
It’s used in three steps chemical synthesis only:
- Mesylation reaction using mesyl chloride
- Mesyl group substitution by sesamol,
- salification and salt cristallization using acetic acid or hydrochloric acid

The process is carried on using closed reactors equipped with mechanical seals and valves. The load operation of the raw material (powder) is performed under specific exhaust system by personnel using tivek disposable clothes and mask with powder filter.
Pumps and dedicated pipes, made by compatible material, are used to move liquid or suspension from a reactor to another.
The intermediates are isolated using centrifuge completely sealed and inert zed by nitrogen.
The mother liquors are collected in dedicated tank using closed loop pipes and stored before to be send to the external waste.

There are no emissions in the work places in the normal production condition. The only hypothetical emissions are related with accident scenario.There are not diffuse emission. During the periodic enviroment controls in the work place no presence of the substance was found

The work places and the SOP are compliant with the actual Italian legislation ( D.Lgv 81/2008,D. Lgv 334/99-Seveso ). The production facility is managed through a Safety System (SGS) which is periodically controlled by the authority. All the production equipments (reactors, tanks, filters, driers) are made in the right materials and are managed by a preventive maintenance program.
All the “in pressure“ equipments are periodically verified by the authorities (ARPA, ISPSEL). The work places are periodically verified by the authority and by an external specialist in Labour Medicine and preventively authorized by the Italian Inter Minister (VVFF).
All the production areas are classified following the ATEX regulation and a Fire Prevent Certification (CPI) is available.
The health of the personnel dedicated to the raw material, intermediates and finished products handling is periodically monitored by a Labour Medicine specialist following a preapproved sanitary protocol.
The workers (production, warehouse, laboratories) are informed and trained on the chemical and toxicological characteristics of the substance in use and they are trained on the individual protection devices and safety procedure. The personnel is even trained on the emergency events and first aid.
Updated “ Material Safety Data Sheets “, 16 points European form, are available in the work place.
A complete collection of written SOP related to the GMP and Safety is available in the work places.

Transport information

Shippingopen allclose all
SpecialProvisionsopen allclose all
Shippingopen allclose all
Remarksopen allclose all

Marine transport (IMDG)

Remarksopen allclose all
Remarksopen allclose all
SpecialProvisionsopen allclose all

Exposure controls / personal protection

Stability and reactivity

Disposal considerations