How to Build a SDS with Robust Toxicological Data

Tox by Design can develop Safety Data Sheets with a special focus on the following sections:

SDS Section 2: Hazards Identification

This section of the safety data sheet describes the hazards of the substance or mixture and the appropriate warning information associated with those hazards.

The classification of the substance is to be given according to the rules of the CLP Regulation.

The hazard(s) that the product present(s) to human health or the environment need to be indicated by means of:

  • Classification: hazard class and category, including associated hazard statements
  • Label elements: hazard pictogram(s), signal word(s), hazard statement(s) and precautionary statement(s)

The main requirement for this section is section 2.3:

Other hazards, especially if the substance meets the criteria for PBT/vPvB, or if the substance is known for its endocrine disrupting properties.

SDS Section 3: Composition/Information on Ingredients

This section of the safety data sheet describes the chemical identity of the ingredient(s) of the substance or mixture, including impurities and stabilising additives.

Appropriate and available safety information on surface chemistry shall be indicated.

The main requirement for this section is to indicate, if applicable and available:

  • The specific concentration limit ("SCL")
  • The multiplication factor ("M-factor")
  • The acute toxicity estimate ("ATE")

SDS Section 8: Exposure Controls/Personal Protection (PPE)

This section of the safety data sheet describes:

  • Applicable Occupational Exposure Limits ("OEL") and
  • Necessary risk management measures.

SDS section 11: Toxicological Information

This section of the safety data sheet is meant for use primarily by medical professionals, occupational health and safety professionals and toxicologists.

A concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects shall be provided, including where appropriate information, on toxicokinetics, metabolism and distribution.

The main requirement in section 11.2:

Information on other hazards and concerns, as well as information on adverse health effects caused by endocrine disrupting properties, should be provided where available for the substances identified as such.


You can check Socosur Tox methodology for Safety Data Sheet development, signed by an European Registered Toxicologist expert here.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Socosur Tox is duly accredited for the French Research Tax Credit CIR.

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