P&G Beauty & Grooming's Approach to Risk Assessment
Step 3: Safety Testing
Once available data has been reviewed and exposures have been characterized, P&G scientists determine whether testing will be required to substantiate safety. Many ingredients used in our beauty and grooming products have a long history of safe use. However, in cases where scientists are dealing with a new ingredient or a new exposure to an existing ingredient, it may need to undergo additional safety testing. In many cases, the approach to safety testing is outlined by the government and covered by regulations. Safety testing programs are designed to address the most relevant potential hazards and conditions of exposure. A comprehensive safety program may take months or years to complete.
One of the primary objectives of safety testing is hazard identification. In hazard identification, the adverse health effects of a potential new ingredient are identified for a relevant route of exposure.
The major toxicological endpoints evaluated may include, but are not limited to:
- Systemic toxicity (short-term or long-term toxicity)
- Local effects on the skin and eye, such as irritation
- Reproductive toxicity
- Genetic toxicity
- Contact allergy or sensitization of the skin
- Respiratory toxicity
Where possible, these toxicological endpoints can be evaluated for individual ingredients using previous studies, validated in vitro methods or structure-activity comparisons. Read about our latest safety testing innovations to continue to improve safety evaluations. Cosmetic Safety Innovation »
As for animal testing, P&G Beauty & Grooming's position is clear: We do not test our beauty and grooming products on animals; nor do we ask suppliers to test them on our behalf. We also do not test beauty and grooming ingredients on animals, except in rare cases when needed to meet regulatory or safety obligations. Animal Testing Alternatives »
Dose-response studies are done to determine a value such as the No Observed Adverse Effect Level (NOAEL) for any adverse effects identified. This is the highest dose at which no toxicity is observed. Because an ingredient can be associated with several forms of toxicity, the focus of the safety studies is to identify the critical effect which is generally the toxic effect with the lowest NOAEL. Therefore, if a consumer is protected against this effect then protection against all other effects is provided.
For this exercise, let's assume that the critical effect for Ingredient A is skin irritation and the NOAEL was determined to be 5 mg/cm² by dose response studies. The NOAEL of the critical effect is then compared with the human exposure calculation illustrated in Step 2 to determine an acceptable human exposure. A common method used is the Margin-of-Safety (MOS) approach discussed in Step 4.
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