Targeted assessment of a cosmetic ingredient


Bibra was asked to establish a tolerable systemic exposure for a key ingredient in an oral cosmetic product.

In the theoretical case that use of the cosmetic would provide the key ingredient at a dose matching the tolerable exposure, bibra was also asked to establish whether any of the other cosmetic constituents (at defined concentrations in the cosmetic product) might give rise to adverse effects in consumers.


A cosmetics manufacturer.

Project goals

To conduct a thorough review of the available toxicological data on the key chemical constituent, and to derive a tolerable exposure by applying appropriate uncertainty factors to the critical point of departure.

To also perform a pragmatic risk assessment of the other chemical constituents of the product, with a focus on Expert Group reports and opinions.


Toxicity data on the key ingredient and on other constituents of the cosmetic were identified by literature searches, including of the in-house TRACE database. A tolerable daily exposure for the key ingredient was calculated, as were the associated exposures to other chemical constituents in the product.

Project outcome

A tolerable systemic exposure was established for the key cosmetic ingredient. It was concluded that none of the other constituents should give rise to adverse effects at associated exposure levels.

Bibra project team

Beth O’Connell
James Hopkins


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