Executive Summary
1. General data
1.1 Identity of the
ingredient :
2,2'-(1,4-Phenylene)bis)-1H-benzimidazole-4,6-
disulfonic acid, monosodium
salt)
1.2 CAS n° : 180898-37-7
1.3 Use : As an
ultraviolet filter in sunscreen
and other cosmetics at a
maximum concentration of 10%
expressed as free acid.
Maximum absorption at
340 nm.
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
S80 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'-(1,4-Phenylene)bis)-1H-benzimidazole-4,6-disulfonic
acid, monosodium salt)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 Chronic/sub-chronic
toxicity : No evidence of any
dose related abnormalities
3.3 Photo-toxicity : No
photo-toxic potential observed
3.4 Reproductive
toxicity : No evidence of
teratogenicity
3.5 Percutaneous
absorption : No evidence of
absorption of the active
ingredient under the conditions
of the experiment
3.6 Irritation and
corrosivity : No effects
suggesting irritating
properties of the active
ingredient observed
3.7 Allergenicity and
sensitisation : The
allergy/photo-allergy test was
negative. No evidence of
capacity to induce
sensitisation
3.8
Genotoxicity/carcinogenicity :
No evidence of genotoxic nor
mutagenic properties
4. Opinion
The SCCNFP is of the
opinion that
2,2'-(1,4-Phenylene)bis)-1H-benzimidazole-4,6-disulfonic
acid, monosodium salt) 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.