Registration Dossier
Registration Dossier
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Coupling reaction products of diazotized 2-amino-6-[(2-substitued ethyl)sulfonyl]naphthalene-1-substituted acid with 4-({4-chloro-6-[ethyl(3-{[2-(substituted oxy)ethyl]sulfonyl}phenyl)amino]-heteromonocycl-2-yl}amino)-5-hydroxynaphthalene-2,7-disubstituted acid and their sodium and potassium salts
EC number: - | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Summary
Considering the physiochemical properties of FAT 40850, [i.e., high molecular weight for
organic salts (above and around 1000), small log POW value (-4.2), and low vapor pressure of
3.04 x 10-28 Pa at 25 °C (estimate)], absorption of FAT 40850 from various routes of exposure,
such as oral, dermal or inhalation is expected. However, absorption of FAT 40850 is
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expected to mainly occur via oral （50% absorption rate）and inhalation routes (100%
absorption rate), but with limited potential for dermal absorption (10% absorption rate can be
expected).
The results of the 28-day repeated oral toxicity study also provide evidence that the organic
components of FAT 40850 may not cross the blood-brain barrier (BBB) upon oral exposure
and cause CNS effects. Retaining of small particles in the deep lungs via the inhalation route
may not be excluded due to the substance physicochemical properties. Following absorption,
FAT 40850 is anticipated to be distributed at the very least to the kidneys, lungs, mesenteric
lymphnodes and stomach in animals following repeated oral exposure. However, excepting
kidneys, bioaccumulation/deposition of the test material in a short term oral exposure may be
unlikely to cause toxicity concern based on the results of the 28-day and prenatal studies
which displayed no directly substance treated adverse effects in the dosed animals. The
constituents of FAT 40850 having large molecular weight may be metabolized in the liver and
consequently excreted via bile. On the other hand, the inorganic salts/ions may be excreted
mainly through urine.
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.
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