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EC number: 221-264-5
CAS number: 3049-71-6
No expected bioavailability neither orally, dermally nor
inhalative was suggested. No bioaccumulation potential assumed. The test
substance is expected not to be metabolized in the body due to low
solubility in both water and fat. Further, excretion was concluded to
occur via feces. However, no experimental data concerning absorption,
distribution, and metabolism have been conducted.
Assessment of the
The test substance is a
red solid dyestuff with a relative density of 1.479 at 20°C and a
molecular weight of 750.8 g/mol. The test article has a vapor pressure
of < 0.000001 hPa at 20°C and is characterized by very low solubility in
both water (< 10 µg/l at 20°C) and organic solvents (n-octanol: < 0.1
mg/L). The log Pow was estimated based
on the solubility in water and octanol to be 1.0 at 20°C. No studies are
available investigating the toxicokinetic properties of the test
substance. The toxicokinetic behavior is therefore assessed based
on physic-chemical properties and on available toxicity studies
performed with the test article and with other members of the category
(for category justification refer to the attached document).
Based on the very low
water solubility and the low solubility in n-octanol (i.e. fat),
bioavailability of the test substance is generally not expected. This is
supported by the available toxicity studies. In an oral toxicity study
male and female Sprague-Dawley rats (5/sex) were administered the test
substance at a single dose of 5000 mg/kg bw by gavage followed by a
14-day observation period (BASF, 1978). None of the animals died during
the exposure period. Besides red stained feces no abnormal clinical
findings were made and no abnormal findings were made at necropsy. In a
second oral toxicity study rats (5/sex/dose) were administered the test
substance at single doses of 200, 1,600 and 6,400 mg/kg bw by gavage
followed by a 7-day observation period (BASF, 1966). None of the animals
died during the study. Clinical signs were atony, ruffled fur, curved
body position dyspnea and jumpy behavior. The feces were stained red. No
abnormal findings were made at necropsy. The results of both studies do
not indicate any systemic availability of the test substance upon oral
addition, various oral toxicity studies with repeated administration
have been performed with structural analogues of the same category. None
of them revealed any toxicity up to the highest dose levels tested (1000
mg/kg bw and up). These results support the proposed lack of absorbance
for the members of this category. As a result an accumulation of the
test article in the body is not expected.
Dermal absorption is
equally unlikely based on the test compound’s very low solubility
properties in both water and fat. In addition, substances with a
molecular weight of greater than 500 may be too large for dermal uptake.
In a dermal toxicity study performed with a structure analogue no signs
of toxicity were observed with the limit dose of 2500 mg/kg, indicating
a low systemic availability after dermal exposure. In conclusion, based
on the low water solubility together with the results of acute dermal
toxicity studies, dermal absorption of the test article is not expected.
No indications for
absorption after inhalation are given from the available toxicity data
and the physic-chemical properties of the test article. In an inhalation
risk test performed with the test substance (BASF, 1978), the toxicity
of an atmosphere that has been saturated at room temperature with dust
of the compound was investigated. Two groups of rats (3/sex/group) were
exposed sequentially to the dusts for 7 h. None of the animals died
during the exposure period and no abnormal clinical signs were reported.
Body weights and gross pathology were normal. The results of this study
do not indicate systemic availability of the test article. Particle size
distribution analysis showed that 85.3% of the analyzed material was
smaller than 100 µm and 6.7% of the substance was found in particles
smaller than 10 µm. These data demonstrate that the test substance can
be inspired and small fractions may reach the alveolar region upon dust
inhalation. However, since the test article is neither soluble in water
nor soluble in fat, absorption and systemic availability after
inhalation is not expected. Particles deposited in the nasopharyngeal
region will most likely be coughed or sneezed out and particles
deposited in the trachea-bronchial region will be cleared by
mucocilliary mechanisms and swallowed. Dust particles reaching the
alveolar region will mainly be engulfed by alveolar macrophages and
cleared via the ciliated airways or the lymphatic drainage. In
conclusion, the test article can be inspired in the form of dust,
however, as indicated by the acute inhalation toxicity study and based
on the very low solubility, particles are expected to be not absorbed
and not bioavailable.
Considering the chemical
structure of the test article, Cytochrome P450 linked oxidations of the
aromatic ring systems are possible steps in the metabolism. However,
based on the low solubility property in both water and fat, the
substance is most likely not absorbed and excreted unchanged. This is
supported by the observation of colored feces in toxicity studies.
on genotoxicity (Ames assays, BASF, 2011, 2002) were negative, i.e.
there is no indication of a reactivity of the test substance or its
metabolites with biomacromolecules under the chosen test conditions.
Since the test article is
not soluble in water and fat, excretion is expected to occur
predominantly via the feces. This assumption is strengthened by the
observation of colored feces in the toxicity studies. Overall,
accumulation of test material within the body is not expected.
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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