Summary sheet on Commission
Review (Ref XXIV/1291/97)
Ingredient:
1-amino-3-methyl-4-(2-hydroxyethyl)-amino-6-nitrobenzene
CAS n°: 82576-75-8
Function and max in use
concentration: oxidative
(permanent) max 0.5 %; 0.25 %
with H2O2 and semipermanent
(non-oxidative) max 0.5 % -
hair dye
Assessment of acute
toxicity (dermal, oral, i.v.,
i.p.):
Oral toxicity low
Assessment of irritation
& corrosivity:
Very slightly irritating
to mucous membranes, not
irritating to the skin
Assessment of
chronic/subchronic toxicity:
Repeated dose toxicity
- 90 d oral application:
reasonable NOAEL
Assessment of
reproductive toxicity:
No signs of maternal
toxicity, no embryotoxicity or
teratogenic properties within
reasonable dose ranges
Assessment of
genotoxicity/carcinogenicity:
No evidence of mutagenic
activities in appropriate in
vitro as well as in vivo tests
Assessment of
allergenicity/sensitization:
No sensitizing or
allergenic potential
Percutaneous absorption:
In vitro testing
revealed a low absorption rate,
leading to an appropriate
"safety margin"
Classification: 1
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 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.