Executive Summary
1. General data
1.1 Identity of the
ingredient :
4-Amino-3-nitrophenol
1.2 CAS n° : 610-81-1
1.3 Use : oxidative hair
dye, max. use 3.0%; 1.5% in
combination with H2O2.
Semi-permanent hair dye, max.
use 3.0%
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
4-Amino-3-nitrophenol safe for
use in cosmetic products?
* Does the SCCNFP
propose any restrictions or
conditions for its use in
cosmetic products?
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), skin and
mucous membrane irritation,
sub-chronic toxicity (oral),
reproductive toxicity (oral),
genotoxicity, 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
4-Amino-3-nitrophenol can be
used safely in permanent hair
dye formulations at a maximum
concentration of 3.0%. However,
as permanent hair dyes are
mixed with hydrogen peroxide
before application, the maximum
in-use concentration should not
exceed 1.5 %. In semi-permanent
hair dye formulations, the
maximum concentration is 3.0 %.
The animal sensitisation
data in the dossier was
generated with a method not
conforming with OECD n° 406.
Cosmetic products containing
this substance shall carry a
label warning of a risk of
sensitisation.
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.