Executive Summary
1. General data
1.1 Identity of the
ingredient :
6-Acetyl-1,1,2,4,4,7-hexamethyltetraline
1.2 CAS n° : 21145-77-7;
1506-02-1
1.3 Use : Fragrance
ingredient
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
6-Acetyl-1,1,2,4,4,7-hexamethyltetraline
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 3. The
requested data must be
available within 12 months.
4. Opinion
Information on the
purity of the substance should
be provided.
Percutaneous absorption
was insufficiently assessed. A
new in vitro penetration study
has to be provided in
accordance with the SCCNFP
Notes of Guidance.
The absence of
phototoxicity should be
confirmed using the in vitro
3T3 Neutral Red Uptake
Phototoxicity Test.
In its final statement
the SCCNFP will take into
considerations the results of
the investigation and
characterisation of coloration
of internal organs in rats
(announced in Submission 6).
The above has been
formulated only on review of
the cosmetic use of AHTN. For
the full safety assessment of
AHTN, it is necessary to
consider other sources of
consumer exposure from non-food
products e.g., laundry
products.
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.