Summary sheet on Commission
Review (ref. XXIV/1992/97)
Ingredient :
6-(Piperidinyl)-2,4-pyrimidine
diamine-3-oxide and salts.
CAS n° : 38304-91-5
Function and max in use
concentration : hair growth
stimulant 2 %.
Pharmacological
activity: Peripheral
vasodilatator.
Relevant toxicity data :
Assessment of
chronic/toxicity : Cardiotoxic
in long term oral studies
(rats, dogs) Ý very low NOAEL.
Assessment of
reproductive/developmental
toxicity : Foetotoxicity and
maternal toxicity by
subcutaneous inj. (rats) Ý very
low NOAEL.
Human data : Significant
skin absorption.
Classification: 2a (See
Classification of Substances)
SCCNFP Opinion
Minoxidil is a
peripheral vasodilatator acting
on vascular smooth muscle
cells, used as a drug in the
management of severe
hypertension. It may stimulate
some hair regrowth during
continuing topical application.
The SCCNFP is of the
opinion that minoxidil and its
salts (*) must not be used in
cosmetic products because of
their antihypertensive
activity, and because minoxidil
absorption after scalp
application could lead to
systemic effects.
(*) Any minoxidil
derivative used in cosmetic
products must be submitted to
E.C. by industry in view of a
specific assessment.
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.
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.