Registration Dossier
Registration Dossier
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EC number: 255-449-7 | CAS number: 41583-09-9
Endpoint summary
Administrative data
Description of key information
Additional information
No data with the test substance were available. A weight of evidence approach with the read across substance melamine (CAS 108-78-1) is applied. As the substance is a salt of phosphate, effects were read-across from the cation, which is likely to have the more important effects. In biological systems, phosphate is an abundant in cells and body fluids. In ecological terms, because of its important role in biological systems, phosphate is a highly sought-after resource. Thus, read-across from component CAS 108-78-1, melamine, is justified. Several supporting studies of the source substance melamine are available. The supporting studies, 2 on plant toxicity (Jansen, 1982 (DSM), Koch, 1986 (DSM) and 1 on soil nitrifying microorganisms (Hauck, 1964) indicate a low toxicity of melamine.
According to REACH Annex IX 9.4 studies investigating the effects on terrestrial organisms does not need to be conducted if direct and indirect exposure to the soil compartment is unlikely. The Mackay Modelling shows that the soil is no target compartment for melamine. Melamine is distributed only to the water (95 %) and to the air (5 %).
Furthermore, the target test substance has a low potential to absorb to soil. Based on the low n-octanol/water partition coefficient also the adsorption to soil or sediment is expected to be low (Koc < 21; Log Koc < 1.3).
With reference to REACH criterion: "In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms." Guidance Document R.7.c.(ECHA, 2017): The PNECsoil can be estimated by the equilibrium partitioning method from the PNECaquatic, especially in case the substance is not strongly adsorptive, as is melamine. This method is used to estimate the PNEC. Melamine has a low toxicity to mammals and aquatic organisms, not leading to a classification. The chemical safety assessment therefore does not include a risk assessment and therefore do not indicate the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms.
In addition and in relation to the Guidance Document R.7.c (ECHA, 2017).: "The absence of chronic or long-term effects in aquatic organisms up to the substance solubility limit, or of acute effects within the solubility range above 10 mg/L (melamine meets both criteria) can be used to waive the data requirements of Annex IX and X."
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