Evaluation of skin irritation and skin sensitization potential of Moisturex Baby Moisturizing Lotion and Moisturex Baby Shampoo using Human Repeat Insult Patch Test (HRIPT).IS 4011:2018 Guidelines

Topical exposure to chemicals can lead to adverse skin effects or skin intolerances.

While some chemicals will only trigger an irritant response after repeated exposure of the same

skin area, other chemicals will even after a one-time exposure cause irritation.

HRIPT is a standard test; usually performed to check the tolerance of a product on skin after

repeated application of those products on the same site.

Sensitization is the process by which a person becomes, over time, increasingly allergic to a

substance through repeated exposure to that substance. It is very different from irritation

because it involves immune response, the reaction becomes worse with repeated exposure, and

it is usually specific to individuals. The HRIPT consists of 2 phases, possibly 3.

Phase I is the Induction Phase where product is applied to the skin 9 times over duration of 3

weeks. This is a followed by rest period of 10- 14 days after which the skin is exposed to the

product again in Phase II or the Elicitation Phase. A response in Phase II is usually allergic in

nature. In some cases when reactions at challenge are weak or do not follow a consistent

pattern, it may be necessary to conduct additional studies on a participant to determine if the

responses are indicative of allergy. This is Phase III of the study- Rechallenge Phase. A

Rechallenge may also be performed to verify that the response is persistent.