Preparation of a large number of toxicity monographs for a range of consumer-product ingredients


It is mandatory for manufacturers to perform human health risk assessments for their products to ensure the safety of the exposed workforce and consumer. In order to do this a toxicological assessment of all the ingredients used to produce the products is required. The client provided bibra with a list of over 100 ingredients, primarily cosmetics, that required the preparation of hazard reviews.


Formulator and retailer of consumer goods, cosmetics and over-the-counter-medicines.

Project goals

To provide up-to-date, high-quality ADME and toxicity monographs for each ingredient, highlighting any critical findings that may have an impact on human health and therefore would require particular attention at the risk assessment phase of the project.


Literature searches were performed using a range of data-sources to identify relevant ADME and toxicological data on each ingredient. This search was largely based on compound-specific CAS RNs and synonyms. Data-sources included the bibra TRACE database (primarily used to identify expert group reports and other expert and/or comprehensive reviews), PubMed, and the TOXNET system. The relevant sources of data were assessed, with a particular focus being placed on the dermal and inhalation routes of exposure to reflect the product uses.

Project outcome

Bibra produced high-quality ADME and toxicity monographs on a large-number of varied substances (including mono-constituents, multi-constituents, polymers and UVCBs). Each monograph included a concise summary of the critical available data on a range of toxicological aspects, primarily focusing on: irritation, sensitisation, acute/repeated dose toxicity, genotoxicity, carcinogenicity and reproductive/developmental toxicity. They also included, where available, the opinions of appropriate Expert groups, the current regulatory status of the substance (globally), and existing health criteria values (HCVs, e.g. US EPA RfCs, EFSA/JECFA ADIs/TDIs, industry-derived DNELs), and an Executive Summary.

Bibra project team

Richard Young
Anne Edwards
Beth O’Connell
Daniel Threlfall
Charlie Johnson


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