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EC number: 255-449-7
CAS number: 41583-09-9
Ames test: Melamine phosphate was negative.
Chromosome Aberration assay: Melamine was negative.
Mammalian cell mutation assay: Melamine was negative.
Micronucleus assay: Melamine was negative.
was tested in the Salmonella typhimurium reverse mutation assay
according OECD TG 471 with four histidine-requiring strains of
Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and in the
Escherichia coli reverse mutation assay with a tryptophan-requiring
strain of Escherichia coli WPrUvrA. The test was performed in two
independent experiments in the presence and absence of S9-mix
(Aroclor-1254 induced rat liver S9-mix). The substance was tested up to
concentrations of 5 mg/plate in the absence and presence of S9-mix. It
precipitated on the plates at this dose-level. The bacterial background
lawn was not reduced at all concentrations tested and no biologically
relevant decrease in the number of revertants was observed (BASF SE
chromosome aberration study with melamine was performed according to the
US NTP standard protocol which is similar to the procedure outlined in
OECD testing guideline 473. Chinese hamster Ovary (CHO) cells were used
together with and without S9 mix prepared from the liver of Aroclor-1254
induced rats. Applied doses were 240, 270 and 300 µg per plate.
Mitomycin C and cyclophosphamide were used as positive controls.
Melamine was found to be non clastogenic in vitro. Considering the
higher molecular weight of melamine phosphate and that both are of
comparable solubility in water, this data is adequate to conclude that
melamine phosphate is not clastogenic in vitro (Galloway, 1987).
in mammalian cells in vitro was assessed in the mouse lymphoma assay
performed according the US National Toxicology Standard Program which is
comparable to OECD testing guideline 476. Concentrations of melamine
were 0; 10; 20; 40; 80; 100; 120; 140; 160 µg/mL ; testing of melamine
was limited to 160 µg/mL by its solubility in the exposure medium. A
dose-dependent increase in mutant frequency was observed for the
positive control, but not for the solvent control DMSO and not for
melamine. The cloning efficiency was not affected by
melamine.Considering the higher molecular weight of melamine phosphate
and that both are of comparable solubility in water, this data is
adequate to conclude that melamine phosphate is not mutagenic to
mammalian cells in vitro (McGregor 1988).
was investigated in a micronucleus study in vivo. Groups of five mice
were administered the substance at 0, 500, 1000 or 2000 mg/kg by
intraperitoneal injection on three consecutive days. Two days after the
third treatment, animals were sacrificed and bone marrow and peripheral
blood smears prepared. Per animal, two slides per tissue were prepared.
The initial test gave a positive trend (P = 0 .003) from 2.1 in the
control to 3.8 in the high dose (2000 mg/kg). Peripheral blood smears
from the dose determination test were scored and were negative as was a
repeat bone marrow test using doses of 1000 and 2000 mg/kg (Shelby
another micronucleus test according to Standard Operating Procedure
PH-309A, melamine was administered orally to mice in a dose of 1000
mg/kg bw. Distilled water was used as vehicle control and
triethylenemelamine as positive control. Erythrocytes were harvested
from femurs after 30 h, 48h or 72 h and analyzed for micronuclei. The
results for melamine were negative in the Micronucleus Test,
at a dose of 1000 mg/kg in the single dose groups and at 2 x 1000 mg/kg
administered in a split dose regimen to the multiple dose groups. This
is based upon the inability of the chemical to produce a statistically
significant increase in the number of micronuclei per 1000 polychromatic
erythrocytes in the treated versus the control group (American Cynamide
PH 309A-AC-001-81, 1981).
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008:
The available experimental test data are reliable and suitable for classification purposes. As a result the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EU) No. 2020/217.
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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