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Hydroxypropyl p-Phenylenediamine (A165) : preliminary Opinion of the SCCS

Hydroxypropyl p-phenylenediamine (A165) : Opinion préliminaire du CSSC

Following the mandate given by the European Commission, the SCCS has carried out a new safety assessment of the hair colouring ingredient Hydroxypropyl p-Phenylenediamine and its dihydrochloride salt (A165). The Scientific Committee has just published its preliminary Opinion. It is open to consultation until 8 January 2024.

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Background

Hydroxypropyl p-Phenylenediamine and its dihydrochloride salt are hair dye ingredients, currently not regulated by Cosmetics Regulation (EC) No.1223/2009.
In a first Opinion, the SCCS considered that “Hydroxypropyl p-Phenylenediamine and its dihydrochloride salt are not safe when used in oxidative hair colouring products due to potential genotoxicity.”
The industry then provided new data to defend the use of these substances in oxidative hair colouring products up to a maximum on-head concentration of 2%.

For an exhaustive background information, see the article
Hydroxypropyl p-Phenylenediamine: new request for Opinion to the SCCS, CosmeticOBS, 10 October 2022

Opinion

1. In light of the data provided, does the SCCS consider Hydroxypropyl p-Phenylenediamine and its dihydrochloride salt safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2%?

In light of the data provided, the SCCS considers that hydroxypropyl p-phenylenediamine and its dihydrochloride salt are safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2%.

2. Does the SCCS have any further scientific concerns with regard to the use of Hydroxypropyl p-Phenylenediamine and its dihydrochloride salt in cosmetic products?

A mild to moderate eye irritation potential of the test item cannot …

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