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EC number: 253-575-7
CAS number: 37640-57-6
Repeated-dose exposure to melamine cyanurate revealed kidney as the
target organ of systemic toxicity at very low doses. The mode of action
is precipitation of poorly soluble crystals of the parent compound which
is not related to reproductive toxicity.
Experimental data on the components melamine and cyanuric acid show no
reproductive toxicity hazard at doses exceeding by far the threshold for
melamine cyanurate crystal formation in the kidney. Therefore, both
components were tested for fertility or toxicity to reproductive organs
at much higher doses that could be tolerated for melamine cyanurate.
For melamine, no developmental toxicity was observed in a GLP compliant study following OECD testing guideline 414 (BASF 1996). Absence of a teratogenic potential was reported in a short summary of a teratogenicity study with sodium cyanurate (Cascieri 1983) and in a screening study according to OECD 422 (MHLW 1997). A study following the procedure of OECD 421 (feed application) is in the in-life phase (August 2016).
the in-life phase (Augu
the in-life phase (Augu
The potential for
developmental toxicity is derived from experimental data on the
components melamine and isocyanuraric acid. Melamine cyanurate is of
much more effective in causing nephrotoxicity than either melamine or
cyanuric acid by themselves. Therefore, the experimental data on the
components is suitable for assessment of a reproductive toxicity hazard. For
melamine, no developmental toxicity was observed in a GLP compliant
study following OECD testing guideline 414 (BASF 1996); the NOAEL of
maternal toxicity was 400 mg/kg bw. Absence of a teratogenic potential
at 5000 mg/kg bw was reported in a short summary of a teratogenicity
study with sodium cyanurate (Cascieri 1983). No developmental toxicity
hazard was identified in a GLP compliant screening study (OECD 422) with
cyanuric acid up to the highest tested dose of 600 mg/kg bw (MHLW 1997).
The doses tested for the components exceed by far the effective doses
causing renal toxicity, therefore it is concluded that melamine
cyanurate has no teratogenic properties.
This is confirmed by a supporting developmental toxicity study in rats
conducted with a 1:1 mixture of melamine and cyanurate (Kim et al.,
2013). In this study, developmental effects were confined to reduced
fetal body weight and delayed fetal ossification, which were both noted
at a dose level associated with clear maternal toxicity. The 1:1 mixture
of melamine and cyanurate was not teratogenic under the conditions of
this reliable supporting study.
No experimental data is available in how far melamine cyanurate is
transferred to human breast milk.
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for
classification purposes under 67/548/EEC. As a result the substance is
not considered to be classified for reproductive toxicity under
Directive 67/548/EEC, as amended for the 28th time in Directive
Classification, Labelling, and Packaging Regulation (EC) No.
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. As a result the
substance is not considered to be classified for reproductive toxicity
under Regulation (EC) No. 1272/2008.
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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