Executive Summary

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.

4. Opinion

The SCCNFP is of the opinion that :

- 2,4-DPO is not a derivative of Minoxidil;

- it is unknown as to whether 2,4-DPO exerts any pharmacological activity when used in cosmetic products at doses and applications as currently proposed;

- under the stated conditions of use, the safety profile of 2,4-DPO does support its safe use in cosmetic products.

At present, the SCCNFP does not recommend any specific warnings or restrictions under the currently proposed conditions of use.

However, as it is a new substance in cosmetic products, it is suggested that there should be adequate surveillance of any side-effects in consumers.

5. Statement on the toxicological evaluation

The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.

The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.

The extend to which these validated methods are applicable to cosmetic products and its ingredients is a matter of the SCCNFP.

SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.