Previous research carried out by the cosmetics manufacturer characterised the anti-ageing potential of AAA and it has been proposed as a novel active ingredient for use in cosmetics
The safety of the active was assessed by following an in-house-developed ‘New Ingredient Testing Strategy’, which built a safety profile for AAA, comprising of a detailed literature and data bank search, in vitro safety testing, margin of safety (MoS) calculation and human compatibility testing.
The aim of this is to provide a library of safe ingredients, and where required, to remove potentially unsafe ingredients at the earliest opportunity to prevent further investment in the research phase.
Having performed this, the Oriflame team, made up of Paul Daly and Garrett Moran, says: “Taking into account all of the information, the ‘New Ingredient Testing Strategy’ has been proven to be an effective approach for assessing the safety of AAA in this instance.”
“This strategy allows the safety assessor to meet the stringent requirements of the EU Cosmetics Regulation and to overcome the challenges presented by the animal testing ban.”
Assessment
The team conducted its research by starting with a literature review of over 40 different information sources, to highlight a number of gaps which required testing data.
From this, AAA was tested for photo-toxicity according to OECD test guideline 432, skin irritation according to OECD test guideline 439 and eye irritation according to OECD test guideline 437.
Dermal absorption of the ingredient was also measured according to OECD test guideline 428 and was used to calculate the MoS, before it was tested in a human repeat insult patch test (HRIPT) and a 14-day in-use tolerance study.
These tests found that AAA was non-phototoxic and was non-irritating to skin and eyes in in vitro testing, while dermal absorption was calculated to be 5%.
The MoS was 351, at a level of 5%, for all cosmetic product types, indicating no systemic safety toxicity concern, and repeated application to the surrounding eye area, twice a day for 14 days, in 21 female volunteers, demonstrated that 1% AAA was well tolerated.
Requirement
The safety of finished cosmetic products must meet the legal requirements of the EU Cosmetics Regulation and the safety of the new ingredient should be assessed in line with the guidelines of the SCCS.
Over the past decade, the cosmetic industry has had to adapt to the introduction of more stringent regulations and to the implementation of the animal testing ban.
To adapt to these changes, cosmetic companies need to have experienced cosmetic safety assessors to certify the safety of their products and need to design alternative testing strategies to overcome the challenges of the animal testing ban.