Registration Dossier
Registration Dossier
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EC number: 203-615-4 | CAS number: 108-78-1
Endpoint summary
Administrative data
Description of key information
Additional information
According to REACH Annex IX 9.4 studies investigating the effects on terrestrial organisms do 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 %), see Section 5.4.3 "BASF SE. Mackay Calculation".
Furthermore, melamine 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, i.e. in the range of 1.1 to 1.5. (EPI Suite Calculation: Koc: 32.28 L/kg; Log Koc: 1.509, see Section 5.4.1 "QSAR.Adsorption").
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.: 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.
The chemical safety assessment does not indicate the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms.
Guidance Document R.7.c.: "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."
The supporting studies, 2 on plant toxicity (Jansen 1982, Koch 1986) and 1 on soil nitrifying microorganisms (Hauck 1964) indicate a low toxicity of melamine.
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