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EC number: 204-847-9
CAS number: 127-52-6
No carcinogenicity studies are planned to be performed.
Chloramine B trihydrate does not need to be
classified for carcinogenicity according to the Directive 67/548/EEC,
Annex VI and CLP regulation (No. 1272/2008 of 16 December 2008).
No genotoxic potential for humans was found in the
genotoxicity studies with Chloramine B trihydrate, including in vitro
bacterial reverse mutation, chromosome aberration and in vivo
micronucleus testing, nor in read across data from Chloramine T
Micronucleus test, and neither in a mammalian gene mutation test with
Benzenesulfonamide. Therefore, genotoxic carcinogenicity can be
On the other hand, there were no indications for
non-genotoxic carcinogenicity based on the suchchronic and chronic
toxicity testing. Chloramine B trihydrate when tested in a 90 -day oral
gavage toxicity study at dose levels 20, 60, 180 mg/kg bw/day, showed
LOAEL (Lowest Observed Adverse Effect Level) for males and females as 60
mg/kg bw/day and NOAEL (No Observed Adverse Effect Level) for males and
females at 20 mg/kg bw/day. The liver was considered
as a target organ based on irreversible increase in serum bilirubin in
high dosed females, significant increases in liver weights (not
reversible) and changes of liver colour (reversible)
at (mid and) high dosed male and female rats. These changes were without
associated histological findings, therefore they might be adaptive
rather than toxicological and certainly do not represent any
preneoplastic changes. The kidneys were also target organs based on
histological findings, although hyaline droplets in
renal tubules of mid and high dosed males are not relevant for humans.
There was however ‘mesangial cell proliferation’ in the renal glomeruli
at 180 mg/kg. Proliferative lesions
associated with the renal corpuscle involve Bowman´s capsule, the
mesangium and the juxtaglomerular body. None of these lesions has been
associated with neoplasia in the
rat. (Hard, G.C., Alden, C.L.,
Stula, E.F., Trump, B.F., 1995, Proliferative Lesions of the Kidney in
Rats, In: Guides for Toxicologic Pathology, STP/ARP/AFIP, Washington, DC). These
lesions may be immune mediated, infectious, toxic, mechanical, or of
other etiologies. A prominent histological feature of many experimental
glomerular inflammatory diseases is cellular hyperplasia in the
mesangium (proliferation of mesangial cells and an influx of leucocytes
(H. O. Schöcklmann, S. Lang, R. B. Sterzel, Regulation of mesangial cell
proliferation, In: Kidney International, Vol. 56, 1999, pp. 1199-1207). According
to the International Harmonization of Rat Nomenclature „mesangial
hyperplasia“ belongs to non-preneoplastic proliferative lesions. (The
international harmonized nomenclature is the reset of discussions among
the Rat Nomenclature Reconciliation Subcommittee, a presentation during
the 1999 Annual STP Meeting in Washington, D.C., and comments which have
been sent to the committee up to December 1999. The drafts were based on
the STP, WHO/IARC/RITA and NACAD nomenclature systems and were present
for discussion in the Internet since Spring 1999.)
Finally there were no structure activity
relationships for genotoxic and non-genotoxic carcinogenicity when
tested with the public Toxtree (Q)SAR tool for structure activity
relationship. Toxtree is a validated system containing a
rule-based system for alerts based on an extensive databases according
to Benigni-Bossa. Toxtree was applied to both Chloramine B and T as
major test substances and to Benzenesulfonamide and p-Toluenesolfonamide
(and o-Toluenesulfonamide) as major metabolites (and comparators). They
were all found negative for alerts, therefore they were predicted
negative for carcinogenicity.
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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