Executive Summary
1. General data
1.1 Identity of the
ingredient :
2,2'-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-
(1,1,3,3-tetramethylbutyl)phenol)
1.2 CAS n° : 103597-45-1
1.3 Use : cosmetics,
plastic material
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.
Request for inclusion of
S79 in Annex VII, part 1 - List
of UV filters which Cosmetic
Products may contain - to
Council Directive 76/768/EEC.
2.2 Request to the
SCCNFP
The SCCNFP is requested
to answer the following
questions :
* Is
2,2'-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)
safe for use in cosmetic
products?
* Does the SCCNFP
propose any restrictions or
conditions for its use in
cosmetic products?
3. Toxicological
Evaluation &
Characterisation
3.1 Acute toxicity
(dermal, oral) : No special
signs of toxicity were observed
3.2 Sub-chronic toxicity
(oral) : No evidence of toxic
effects on either the in-life
or pathomorphological
parameters
3.3 Photo-toxicity : No
evidence of photo-toxicity
3.4 Reproductive
toxicity : No teratogenic
potential observed
3.5 Percutaneous
absorption : The overall
penetration of the test
substance through the skin is
very low and is taken into
account for the calculation of
the margin of safety.
3.6 Mucous membrane/
acute eye irritation :
Non-irritant according to
83/467/EEC
3.7 Skin irritation :
Non-irritant according to
83/467/EEC
3.8 Allergenicity and
sensitisation: No allergenic
reactions observed
3.9 Photo-allergenicity
: No photo-allergenic reactions
observed
3.10 Photo-sensitisation
: No evidence of
photo-allergenic potential
3.11
Genotoxicity/Mutagenicity : Not
genotoxic nor mutagenic in
presence or absence of
metabolic activation
3.12 Photo-mutagenicity
: Not photo-mutagenic
3.13 Photo-stability :
highly photo-stable
4. Opinion
The SCCNFP is of the
opinion that
2,2'-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)
is safe for use in cosmetic
products as a UV light absorber
at a maximum concentration of
10%.
The SCCNFP proposes no
further restrictions or
conditions for its use in
cosmetic 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.
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.