Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Due to all technical measures to prevent contamination the exposure of the personnel is unlikely.

The following control measures have been identified as suitable control measures:

- Dust extraction units and laminar flow ventilation for charging/dischatging

- HVAC operates in all areas

- Regular maintenance is carried out on all ventilation installations.

- Respiratory protection equipment and personal protective equipment is specified

Process Safety Training regarding the use of control measures and the actions to be taken in the event of control measure failure is performed by the Process manager at the start of the production campaign and on a three-monthly basis thereafter.

The personal protective measure may be adapted appropriately when working in closed systems:

Respiration : Dust mask (tested in line with EN 149), approved respirator or airhood.

Filter : Combination filter

Eye : Wear approved safety glasses or visor

Hand : All KCL chemical protective gloves used on-site provide >8 hours protection

Additional protection : Wear chemical protective suit tested in line with EN 369/374-3

The site will be operating by the end of 2020 and it will be closed in 2021. The last campaign of DIACETYL-L-THYMIDINE production is planned in 2019.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Due to all technical measures to prevent contamination the exposure of the personnel is unlikely.

The following control measures have been identified as suitable control measures:

- Dust extraction units and laminar flow ventilation for charging/dischatging

- HVAC operates in all areas

- Regular maintenance is carried out on all ventilation installations.

- Respiratory protection equipment and personal protective equipment is specified

Process Safety Training regarding the use of control measures and the actions to be taken in the event of control measure failure is performed by the Process manager at the start of the production campaign and on a three-monthly basis thereafter.

The personal protective measure may be adapted appropriately when working in closed systems:

Respiration : Dust mask (tested in line with EN 149), approved respirator or airhood.

Filter : Combination filter

Eye : Wear approved safety glasses or visor

Hand : All KCL chemical protective gloves used on-site provide >8 hours protection

Additional protection : Wear chemical protective suit tested in line with EN 369/374-3

The site will be operating by the end of 2020 and it will be closed in 2021. The last campaign of DIACETYL-L-THYMIDINE production is planned in 2019.