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EC number: 273-227-8
CAS number: 68953-84-4
Skin irritation: according to the criteria established for Primary Irritation Index, 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. is rated “slight irritant”.Eye irritation: according to the results of the acute eye irritation test, the 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. was not found irritating to the eye.
2 Skin irritation studies in rabbits were available for assessment. Both
studies were performed according to GLP and internationally accepted
guidelines. The study by Merriman (1995) was chosen as the key study,
since in this study slight signs of irritation were noted, whereas the
study by Bomhard and Martins (1990) did not show any signs of skin
1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. was subjected to a
dermal irritation assessment consistent with methods described by OECD
and EPA. Following application of undissolved test chemical to rabbit
skin sites for a period of 4 hrs under semi-occlusive dressing, scoring
for signs of irritation were made at 1, 24, 48, & 72 hrs following
removal of residual chemical. The scoring system used was based upon the
Draize method. Only signs of slight erythema were observed. According to
criteria established for Primary Irritation Index, the chemical is rated
"slight irritant", though not to such a level as to trigger
classification under CLP.
The key study was performed with 1,4 -benzenediamine, N,N'-mixed Ph and
tolyl derivs. according to the OECD 405 test guideline. In the study the
test material was not irritating to the eye (exposure period 24h). Some
slight conjunctivitis was only observed 1h after application at all
three animals. By day 21, all animals were free of irritation signs. The
mild and transient reactions of the mucous membranes immediately
following exposure of the solid test substance into the eye are
considered as mechanically induced effects.
No data regarding respiratory irritation are available for
1,4-benzenediamine, N,N'-mixed Ph and tolyl derivs. As the irritating
properties of this substance when administered via the oral or dermal
route are very limited, it can be assumed that the respiratory
irritation potential of the substance would be likewise. Moreover, as
this multi-constituent substance has a very low vapour pressure and
virtually no particles of inhalable size, exposure via the respiratory
route is not likely.
In the key study used for classification and labelling (Merriman, 1995)
6 rabbits were used instead of 3. As a consequence, the “Guidance on the
Application of Regulation (EC) No 1272/2008” prescribes in section
18.104.22.168.2.2 that two approaches for evaluation of the irritation effects
should be used and compared in order to use the more stringent result.
Approach 1 is based on the arithmetic mean value of all animals.
According to the test results, the arithmetic mean after 24/48/72 hours
for erythema is below 0.5. As no signs of oedema were noted, the
arithmetic mean for this effect is 0. Both values are below 2.3, i.e. no
classification is warranted with regard to skin irritation.
Approach 2 is based on the average score per animal. According to the
test results, the average score per animal is below 1 in all cases for
erythema, and 0 for oedema. The cut-off value of 2.3 is reached for none
of the test animals, i.e. no classification is warranted with regard to
It can thus be concluded from both approaches that 1,4-Benzenediamine,
N,N'-mixed Ph and tolyl derivs. should not be classified as skin
irritant according to EU Classification, Labelling and Packaging of
Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
When comparing the recorded effects for erythema and oedema to the
criteria specified in Directive 67/548/EEC (Dangerous Substances
Directive), none of the 3 criteria (mean scores ≥ 2.3 or persisting
inflammation, or very definite positive effect in a single animal) is
fulfilled. As a consequence, classification of 1,4-benzenediamine,
N,N'-mixed Ph and tolyl derivs. as corrosive or irritant to the skin is
not deemed necessary.
The mean scores per animal following grading at 24, 48 and 72 hours are
in all cases below the cut-off values as defined in the criteria for
reversible effects on the eye (Category 2). The mean values per animal
for corneal opacity, iritis and conjunctival oedema are 0. The mean
value for conjunctival redness is below 0.5 for all of the animals. As a
consequence, no classification is warranted with regard to eye
irritation category 2 of EU Classification, Labelling and Packaging of
Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
When comparing the observed effects with the criteria specified in
Directive 67/548/EEC (Dangerous Substances Directive), it can be
concluded that these criteria (irreversible effects in at least one
animal and/or a positive response in at least 2 of 3 tested animals of ≥
3 for corneal opacity and/or > 1.5 for iritis) are not fulfilled. As a
consequence, classifcation of 1,4-benzenediamine, N,N'-mixed Ph and
tolyl derivs. as irritating to the eye is not deemed necessary.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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