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EC number: 617-116-8
CAS number: 80573-04-2
Default (DNEL calculator)
All industrial activities involving the use of Balsalazide acid will
take place under strict Good Manufacturing Practices (GMP).
Exposure of balsalazide acid to the general population will be
negligible as it is an intermediate substance used in the synthesis of
pharmaceutical ingredients. The intake of the pharmaceutical by the
general public is not covered by REACH legislation.
In accordance with the use information detailed in the pharmacology
document attached in Section 13.2 of IUCLID, the maximum daily dose of
the pharmaceutical balsalazide disodium salt (Colazide) is 6.6 g/day.
This corresponds to 5.8 g/day of balsalazide acid or 97.9 mg/kg bw/day.
Therefore, the DNEL values calculated above are likely to be very
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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