1. General data

1.1 Identity : 2,4-Diamino-pyrimidine-3-oxide

1.2 CAS n° : 7438-76-9 (anhydrous ingredient)

1.3 Use : hair care formulations to prevent increased hair loss

1.4 Conditions of use : the cosmetic preparation is a solution containing 1.5% 2,4-DPO in ethanol/water. The product is available as a set of vials, each containing 6 ml, corresponding to a total of 90 mg 2,4-DPO per vial and per treatment. The recommendations for use of 2,4-DPO specify application of one vial per treatment to the scalp at least three times a week.

2. Terms of reference

2.1 Context of the question

The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.

2.2 Request to the SCCNFP

The SCCNFP is requested to answer the following questions :

* Is 2,4-DPO a derivative of Minoxidil?

* Does 2,4-DPO exert a pharmacological activity when used in cosmetic products at current levels/as currently proposed?

* Does the safety profile of 2,4-DPO support its safe use in cosmetic products?

* If 2,4-DPO is considered suitable for use in cosmetic products, does the SCCNFP recommend any specific warnings or restrictions?

3. Safety Assessment & Classification

The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.

Evaluation of acute toxicity (oral, dermal), skin and mucous membrane irritation, sensitisation, sub-chronic toxicity (oral, dermal), chronic (oral, dermal), reproductive toxicity (oral), genotoxicity, carcinogenicity, percutaneous absorption have shown that the compound can be safely used under the conditions stated in the Opinion.

Anti hair loss: Ru58841/Minoxidil Powder/Setipiprant /Dutasteride/Finasteride Powder