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Data sharing

Precompetitive data sharing initiatives that support risk assessments by providing fast access to high-quality data

We work collaboratively with industry members to develop data sharing initiatives that support precompetitive data sharing and industry progression

Sharing Ames mutagenicity results

Aromatic Amines

Advancing the understanding of Ames mutagenicity assays for primary aromatic amines.


Sharing Ames mutagenicity results for common intermediates and in vitro mammalian cell assays.

Complex Nitrosamines

Anonymously sharing Ames data on structurally complex nitrosamines.

Sharing excipient and vehicle toxicity data


Assessing the levels of nitrites in pharmaceutical excipients, solvents and reagents.

Elemental Impurities

Supporting more scientifically driven risk assessments under ICH Q3D.


Facilitating data sharing on the tolerability of pharmaceutical excipient formulations.

Sharing Acceptable Intake (AI) and Permitted Daily Exposure (PDE) data


Supporting you in defining compound-specific acceptable exposure limits.

Sharing analytical and Ames data on nitrosamines


Sharing analytical data on the levels of nitrites in common excipients, reagents and solvents, and mutagenicity data on structurally-complex nitrosamines.

Additional data sharing collaborations

FDA Research Collaboration Agreement

Making use of publicly releasable FDA data to make improvements to our software.

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