Registration Dossier
Registration Dossier
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EC number: 476-900-6 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
There are no studies available specifically examining the toxicokinetics of the substance registered or for the analogue substance 2 (refer to IUCLID chapter 13).
The substance is manufactured in aqueous medium and not isolated, but the notified substance as such is a solid prepared by drying. The substance will be used as an aqueous solution, so inhalation exposure is not anticipated.
The substance registered belongs to a group of Leucophores which are of high molecular weight and are very water soluble. The test substance registered has a high water solubility (608 g/L) and its Log Pow is less than -4.It is hydrolytically stable at pH 4, 7 and 9 and its vapour pressure is negligible (3.4E-32 Pa,calculated value).
Absorption and metabolism
Due to its hydrophilic character, the very low octanol-water partitioning coefficient and the high molecular weight, bioavailability is expected to be low. It is not likely that the substance will be absorbed through skin by passive diffusion, due to its poor solubility in lipids.A contact sensitization study conducted on the registered substance
was negative, which might imply that the substance would not be expected to bind to proteins. No treatment related effects were seen in an acute oral toxicity study or in an acute dermal study on the notified substance. In a two-generation toxicity study conducted with the analogue substance 2 (refer to IUCLID chapter 13), treatment related kidney changes (i.e. increase in organ weight without clear microscopic evidence effect) were observed, which indicate that absorption could occur from the gastro-intestinal tract.From the chemical structure, enzymatic cleavage might be expected possibly with production of sulfonamides and subsequent conjugation reactions. The high water solubility of the parent substance, however, suggests that excretion could occur without biotransformation.Hydrolysis does not constitute a relevant metabolic degradation mechanism.
Distribution and Excretion
Since the registered s
ubstance is of high water solubility and has a low Log Pow, the substance is not expected to accumulate in fatty tissue. It is anticipated that the substance will be delivered from the portal vein blood to the liver and kidneys. Due to the high water solubility the most likely excretion route will be via 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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