Cannabidiol (CBD) is gaining prominence as a sought-after ingredient in skincare and beauty formulations, thanks to its notable anti-inflammatory, antioxidant and anti-bacterial properties. Derived directly from the hemp plant, this compound is increasingly being used as an ingredient in skincare products, particularly for the management of various skin conditions like eczema, dermatitis and psoriasis.
Despite topical cannabinoids rising popularity, the scientific community has seen limited pre-clinical studies with comprehensive data on skin sensitisation, or establishment of safe use levels within a dermal sensitisation quantitative risk assessment.
In an insightful scientific paper by Avon Products International, an in-depth investigation delves into the skin sensitisation potential of CBD. The study specifically focuses on CBD’s application in face cream at a concentration of 0.3%, utilising the innovative Next Generation Risk Assessment (NGRA) framework. In line with the European Cosmetics Regulation (Regulation (EC) No 1223/2009) which prohibits the use of animal testing, and the OECD guideline No.497 which adopts the use of the integrated testing strategy (ITS) defined approach (DA) for skin sensitisation, Avon Products International conducted hazard identification and potency categorisation using ITSv1 DA.
What is the integrated testing strategy (ITS) defined approach (DA)?
The ITS DA utilises in chemico, in vitro and in silico test methods to predict skin sensitisation potential and determine potency sub-classification of chemicals. Both versions of the ITS DA use three key information sources; h-CLAT (an in vitro assay), DPRA (an in chemico assay) and either Derek Nexus for ITSv1 or OECD Toolbox for ITSv2 (an in silico toxicity model).
In the article published in Computational Toxicology, Avon Products International use Derek Nexus together with in chemico and in vitro data within ITSv1 DA to estimate that CBD is a weak sensitiser, which would fall within UN GHS sub-category 1B.
How was read-across used to assess the skin sensitisation potential of CBD?
As a next step to support a Weight of Evidence-based risk assessment, suitable read-across analogues for CBD with existing skin sensitisation hazard and potency data were identified. The data for the four read-across candidates identified confirmed that CBD would be a weak sensitiser. Based on the weak skin sensitisation prediction generated by the EC3 model in Derek Nexus, Avon International Products were able to identify a suitable point of departure value to yield a favourable NGRA outcome. The scientific publication provides a comprehensive literature study of other relevant sensitisation data for CBD which supports this outcome, including SENS-IS data and a supervised human repeated insult patch test. Read the full publication to discover how Derek Nexus, the ITSv1 defined approach and read-across were used to support the use of CBD at 0.3 % in face cream formulation.
Computational approaches to support human risk assessment
Avon Products International submitted this publication as part of a Computational Toxicology special edition, titled Computational approaches to support better human risk assessments on chemical safety. The special edition aims to highlight the need for in silico supported decision-making and to create usable models based upon knowledge and data to propel the field of predictive toxicology beyond animal observations.
In 2023, Kao Corporation, a Japanese chemical and cosmetic company combined ITSv1 with read-across to refine the prediction of skin sensitisation potency for use within a NGRA, discover more in this Lhasa blog.
Have you visited our skin sensitisation assessment page? Find out how the combined capabilities of Derek Nexus, the ITSv1 DA web application and Vitic can support the assessment of skin sensitisation potential and potency of chemicals.
