Executive Summary
1. General data
1.1 Identity of the
ingredient :
3-Iodo-2-propynyl-butylcarbamate
(IPBC)
1.2 CAS n° :
55406-53-6
1.3 Use :
for use as a
preservative in all types of
cosmetic products
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
IPBC in Annex VI, part 1 - List
of preservatives allowed - to
Council Directive 76/768/EEC.
IPBC is provisionally allowed
for use as a preservatives in
cosmetic products to a maximum
authorised concentration of
0.05% until 30 June 1999 (Annex
VI, part 2, n° 29).
2.2 Request to the
SCCNFP
The SCCNFP is requested
to answer the following
questions :
* Is
3-Iodo-2-propynyl-butylcarbamate
(IPBC) safe for use in cosmetic
products?
* Does the SCCNFP
propose any restrictions or
conditions for its use in
cosmetic products?
2.3 Definitions of terms
where appropriate.
Not applicable
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, dermal), skin
and mucous membrane irritation,
sub-chronic toxicity (oral),
sensitisation, reproductive
toxicity (oral), genotoxicity,
percutaneous absorption,
dose-dependent adverse effects
(Cholinesterase activity
inhibition) have shown that the
compound can be safely used
under the conditions stated in
the Opinion. The same is valid
for an evaluation of possible
influences of IPBC (especially
its iodine contents) on
endocrine functions.
4. Opinion
The SCCNFP is of the
opinion that
3-Iodo-2-propynyl-butylcarbamate
(IPBC) is safe for use in
cosmetic products as a
preservative at a maximum
concentration of 0.05%.
The SCCNFP proposes the
following further restrictions
or conditions for its use in
cosmetic products : the
substance should not be used in
oral hygiene and lip products.
Leave-on products, containing
more than 0.02 % of
3-Iodo-2-propynyl-butylcarbamate
(IPBC), must be labelled
'Contain Iodine'.
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.