title: Safety assessment of a novel active ingredient, acetyl aspartic acid, according to the EU Cosmetics Regulation and the Scientific Committee on Consumer Safety guidelines.
abstract: OBJECTIVE
  Acetyl aspartic acid (A-A-A) was proposed as a new novel active ingredient for use in cosmetics. The safety of A-A-A was assessed by following an in-house-developed 'New Ingredient Testing Strategy', which was designed in accordance with the Scientific Committee on Consumer Safety (SCCS) notes of guidance and the requirements of Annex I of the EU Cosmetics Regulation. The aim of the project was to determine whether A-A-A was safe for use in cosmetics and to determine a maximum permitted safe level in the formulations.
  
  
  METHODS
  A literature review was conducted, consulting over 40 different information sources. This highlighted a number of gaps which required testing data. A-A-A was tested for phototoxicity 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 A-A-A was measured according to OECD test guideline 428 and was used to calculate the margin of safety (MoS). Finally, A-A-A was tested in a human repeat insult patch test (HRIPT) and a 14-day in-use tolerance study.
  
  
  RESULTS
  A-A-A was non-phototoxic and was non-irritating to skin and eyes in in vitro testing. Dermal absorption was calculated to be 5%. The MoS for A-A-A was 351, at a level of 5%, for all cosmetic product types, indicating no systemic safety toxicity concern. A-A-A at 5% under occlusive patch on a panel of 50 adult volunteers induced no skin irritation or allergic reaction in the HRIPT study. Finally, repeated application of A-A-A to the periocular area, twice per day for 14 days, in 21 female volunteers, demonstrated that 1% A-A-A was well tolerated following dermatological and ophthalmological assessment in a cosmetic formulation.
  
  
  CONCLUSIONS
  A-A-A was assessed as safe by the cosmetic safety assessor for use in cosmetics at a level of 5% in all cosmetic product types, in line with the requirements of the EU Cosmetics Regulation and in accordance with the SCCS notes of guidance.
authors.affiliation: Oriflame R&D Ltd, Bray Business Park, Kilruddery, Bray, Co Wicklow, Ireland.
authors.forename: P
authors.initials: P
authors.lastname: Daly
authors.affiliation: Oriflame R&D Ltd, Bray Business Park, Kilruddery, Bray, Co Wicklow, Ireland.
authors.forename: G
authors.initials: G
authors.lastname: Moran
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D001224:Aspartic Acid / Q000009:adverse effects* / Q000031:analogs & derivatives*; D003358:Cosmetics / Q000633:toxicity*; D017408:Guidelines as Topic; D018675:Toxicity Tests
chemical_list: D003358:Cosmetics; D001224:Aspartic Acid
keywords: EU Cosmetics Regulation; Scientific Committee on Consumer Safety notes of guidance; cell culture; cosmetic ingredient safety; safety testing; skin barrier