Executive Summary
1. General data
1.1 Identity of the
ingredient : Ketoconazole
1.2 CAS n° : 65277-42-1
1.3 Field of application
: Topical cosmetic : 1 % of
ketoconazole in rinse-off and
leave-on products
1.4 Other usage data : 2
% Ketoconazole-containing
licensed shampoo
2. Terms of reference
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.
Technical adaptation to
Annex III of Directive
76/768/EEC, List of substances
which cosmetic products must
not contain except subject to
restrictions and conditions
laid down.
3. Safety Assessment
& Classification
The assessment followed
the SCCNFP 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,
intravenous), repeated dose
toxicity (dermal), skin and
mucous membrane irritation,
sub-chronic toxicity (oral,
dermal), reproductive toxicity
(oral), genotoxicity, chronic
toxicity (oral, dermal),
percutaneous absorption and
also dose-dependent endocrine
and other adverse effects 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 Ketoconazole can
be used safely in both
rinse-off and leave on cosmetic
products, excluding oral care
products. According to the
existing data, its maximum
authorised concentration in the
finished cosmetic product
should be restricted to 2.0 %.
In order to avoid any
risk by accidental intake,
cosmetic products containing
Ketoconazole should not be used
by nursing mothers.
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.
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.